Orlandini, Alessandra. (49178). Azienda Ospedaliera Universitaria di. Parma ...... Name and Address of IEC/IRB. Subinvestigators. Horsmans, Yves. (45227).
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
16.1__4
Investigators and Other Important Participants in the Study
16.1__4.1
List and Description of Investigators
1
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Agarwal, Kaushik (Kosh) (44408)
University College London Hospitals NHS Foundation Trust Institute of Liver Studies King's College Hospital Denmark Hill London, SE5 9RS United Kingdom
Central: NRES Committee Research Health Authority – London Bridge Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Al-Chalabi, Thawab Audimoolam, Vinod Barnabas, Ashley Carey, Ivana Verma, Suman
Aguilar, Humberto (42730)
Louisiana Research Center, LLC Suite 318 1453 East Bert Kouns Shreveport, LA 71105 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Barber Stephens, Brandi Burgoyne, Michelle Anne Carroll, Beverly Chambers, Winde Davis, Jeremy Payne Dies, David Frank Giddings, Stacy Hatfield, Deborah Hebert, Heather Andrina Hobley, James C Johnson, Lawrence Webster Miller, Seth Wayne Mohan,Sathya Narayana Raj Jagan Paskey, Stacy Philips, David Miller Poch, Arthur Lewis Provenza, John Mark Rimmer, Jr., Douglas Edward
2
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Aguilar, Humberto (continued) (42730) Bacon, Bruce (38646)
Subinvestigators Robinson, Thomas Russell Salter, Robert Matthew White, John Michael
St. Louis University Gastroenterology and Hepatology Clinical Research Unit 2nd Floor 3545 Lafayette Avenue St. Louis, MO 63104 United States
Local: St. Louis University Institutional Review Board Room C110 3556 Caroline Street St. Louis, MO 63104 United States
Befeler, Alex S Burton, Mary Stinson Campbell, Shirley Di Bisceglie, Adrian M Heller, Dorothy L Prather, Charlene M Rao, Savitha Shelley, Nancy L Siegner, Joan M Stewart, Susan Tetri, Brent A Thompson, Judy A Wilkins, Rebecca F Wriston, Kristina L
3
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Banyai, Tivadar (45203)
Bekes Megyei Pandy Kalman Korhaz Infektologia Semmelweis u. 1 Gyula, 5700 Hungary
Central: Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga Medical Research Council Ethics Committee for Clinical Pharmacology Arany Janos u 6-8 Budapest, 1051 Hungary
Lakatos, Piroska Martyin, Tibor Seres, Abel
Barcena Marugan, Rafael (40858)
Hospital Universitario Ramon y Cajal Gastroenterologia planta –1 Carretera de Colmenar Viejo, Km. 9,1 Madrid, 28034 Spain
Local: Hospital Universitario Ramon y Cajal CEIC Area 4 Planta -2 Dcha Ctra. de colmenar Viejo, km. 9,1 Madrid, 28034 Spain Central: CEIC Hospital Parc de Salut del Mar Secretaria Tecnica CEIC-IMAS 1a Planta C/Dr Aiguader, 88- Edifici PRBB Barcelona, 08003 Spain
Garcia-Hoz Rosales, Fernando Gil Grande, Luis
4
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Bennett, Michael (31542)
Medical Associates Research Group Suite 200 8008 Frost Street San Diego, CA 92123 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Flores, Sergio R Kim, Hyun S Politoske, Douglas A Pressman, Jeffrey H Snyder, Richard J Tuohy, Dianne
Berg, Thomas (43114)
Leber- und Studienzentrum am Checkpoint Charlottenstrasse 81 Berlin, 10969 Germany
Central: Medizinische Hochschule Hannover Ethik-Komission - OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany Local: Landesamt fuer Gesundheit und Soziales Ethik-Kommission des Landes Berlin Fehrbelliner Platz 1 Berlin, 10707 Germany
Biermer, Michael Fueloep, Balazs Heyne, Renate Moeller, Bernd Moeller, Hjoerdis
5
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Brunetto, Maurizia (47140)
Azienda Ospedaliera Universitaria Pisana Unita Operativa di Epatologia Via Paradisa, 2 Cisanello Pisa, 56126 Italy
Local: Azienda Ospedaliera Universitaria Pisana Comitato Etico per la Sperimentazione Clinica dei Medicinali Via Roma, 67 Pisa, 56126 Italy
Coco, Barbara Colombatto, Piero Romagnoli, Veronica
Buti Ferret, Maria-Asuncion (47163)
Hospital Universitario Vall d'Hebron Lab ref hepatica Edif. modular azul, planta baja P Vall d'Hebron, 119-129 Barcelona, 08035 Spain
Local: Hospital Universitario Vall d'Hebron CEIC Instituto Recerca 3a planta, Edificio Mediterranea P Vall d'Hebron, 119-129 Barcelona, 08035 Spain Central: CEIC Hospital Parc de Salut del Mar Secretaria Tecnica CEIC-IMAS 1a Planta C/ Dr. Aiguader, 88 - Edifici PRBB Barcelona, 08003 Spain
Mur, Esteban
6
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Caporaso, Nicola (47142)
Azienda Ospedaliera Universita degli studi Federico II Unita Operativa di Gastroenterologia Via Pansini, 5 Naples, 80131 Italy
Local: Azienda Ospedaliera Universita degli studi Federico II Comitato Etico per le attivita biomediche Carlo Romano Via Pansini 5 Naples, 80131 Italy
Camera, Silvia Donnarumma, Laura Granata, Rocco Morisco, Filomena
Cardell, Kristina (45473)
University Hospital Linkoping Dept. of Infectious Diseases Linkoping, 581 85 Sweden
Central: Regionala etikprovningsnamnden i Stockholm FE 289 Stockholm, 171 77 Sweden
Fryden, Aril Ostholm Balkhed, Ase
Crawford, Darrell (46997)
Greenslopes Private Hospital Gallipoli Medical Research Foundation Newdegate Street Greenslopes, QLD 4120 Australia
Local: Greenslopes Private Hospital Research and Ethics Committee Executive Suite Newdegate Street Greenslopes, QLD 4120 Australia
Aye, Chaw Britton, Laurence Corney, Christopher Mair, Adam McCullen, Mark A Stuart, Katherine
7
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Davis, Mitchell (40605)
South Florida Center of Gastroenterology, P.A. Suite #205 1447 Medical Park Boulevard Wellington, FL 33414 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Sacks, Steven R Smith, Matthew J Wahl, Joan K
De Ledinghen, Victor (44366)
Hopital du Haut Leveque Service d'Heato-gastroenterologie et Oncologie Digestive Avenue de Megellan Pessac, 33600 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Chermak-Corvaisier, Faiza Faberes, Carole Foucher, Juliette Vergniol, Julien
Dieterich, Douglas (15228)
Mount Sinai School of Medicine Box 1123 One Gustave L. Levy Place New York, NY 10029 United States
Local: Mount Sinai School of Medicine Program for the Protection of Human Subjects One Gustave L. levy Place, Box 1075, 1st Floor 3 East 101 Street New York, NY 10029 United States
Bansal, Meena Chang, Charissa Fanelli, Donna JC Laverty, Maura Martel-Laferriere, Valerie Ng, Michel Perumalswami, Ponni
8
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Dillon, John (32918)
Ninewells Hospital Biomedical Research Institute, Medical School Gastro Lab Level 5 Dundee, DD1 9SY United Kingdom
Central: NRES Committee Research Health Authority London Bridge Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Evans, Morgan Heron, Tim Miller, Michael
Dufour, Jean-Francois (45400)
Inselspital - Universitaetsspital Bern Universitaetsklinik fuer Viszerale Chirugie und Medizin Freiburgstrasse 10 Bern, 3010 Switzerland
Local: Kantonale Ethikkommission Bern (KEK) Postfach 56 Bern, 3010 Switzerland
De Gottardi, Andrea Semmo, Nasser Stirnimann, Guido
Eisner, Mark (12338)
Florida Medical Clinic, PA Clinical Research Division 38135 Market Square Zephyrhills, FL 33542 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Chami, Tawfik N Ellis, Sandi L Hoyle, Precious Johnston, William Daily Sikes, David Hilton
Elion, Richard (33842)
Whitman-Walker Health 1701 14th Street NW Washington, DC 20009 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Celenza, Tina Dieterich, Megan Henn, Sarah Letourneau, Stephanie Thomas, Karidee
9
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Everson, Gregory (37869)
University of Colorado Denver and Hospital AOP 7th floor 1635 Aurora Court Aurora, CO 80045 United States
Local: Western Institutional Review Board (WIRB) 3535 Seventh Avenue Southwest Olympia, WA 98502-5010 United States
Bambha, Kiran Bhatt, Asmeen Biggins, Scott Burton, James R Forman, Lisa Henrichs, Kelly Pratt, Lindsay Rosen, Hugo Tise, Sarah
Feld, Jordan (43189)
Toronto Western Hospital Liver Centre 6B Fell Pavilion 399 Bathurst Street Toronto, ON M5T 2S8 Canada
Local: University Health Network Research Ethics Board 10th Floor, Suite 1056 700 University Avenue Toronto, M5G 1Z5 Canada
Abu-Amara, Mahmoud Cruz Pereira, Oscar Janssen, Harry Juan, Joshua Shah, Hemant Wong, David
Felizarta, Franco (18161)
Dr. Franco Felizarta, Bakersfield, CA Suite 24 3535 San Dimas Street Bakersfield, CA 93301 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
None
10
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Flamm, Steven (38645)
Northwestern University Suite 19-046 676 North St. Clair Street Chicago, IL 60611 United States
Local: Northwestern University IRB Rubloff Hall, 7th Floor 750 North Lake Shore Drive Chicago, IL 60611 United States
Ganger, Daniel
Forns, Xavier (40722)
Hospital Casa Maternidad Consultas externas de Hepatology c/Sabino de Arana s/n Edificio Helios III, 1a planta Barcelona, 08028 Spain
Local: Hospital Clinic i Provincial Comite Etico de Investigacion Clinica Servicio de Farmacia, Escalera 8 Sotano C/ Villarroel, 170 Barcelona, 08036 Spain Central: CEIC Hospital Parc de Salut del Mar Secretaria Tecnica CEIC-IMAS 1a Planta C/ Dr. Aiguader, 88 - Edifici PRBB Barcelona, 08003 Spain
Lens, Sabela Londono, Maria Carlota Marino, Zoe
11
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Foster, Graham (43110)
The Royal London Hospital Grahame Hayton Unit, (GHU) Ambrose King Centre Whitechapel Road London, E1 1BB United Kingdom
Central: NRES Committee Research Health Authority – London Bridge Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Cunningham, Morven De Silva, Sampath Dearden, Janet Gill, Upgar Hansi, Navjyot Lahiri, Rajiv
Fouchard-Hubert, Isabelle (47939)
CHU d'Angers Service d'Hepato-Gastroenterologie 4 Rue Larrey Angers Cedex 9, 49933 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Boursier, Jerome Cales, Paul Lunel-Fabiani, Francoise Oberti, Frederic
Freilich, Bradley (22854)
Kansas City Research Institute Suite 430 6675 Holmes Road Kansas City, MO 64131 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Kissinger, Janay A
12
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Gane, Edward (38898)
Auckland City Hospital New Zealand Liver Transplant Unit 15th Floor Support Building Park Road, Grafton Auckland, 1142 New Zealand
Central: Multi Region Ethics Committee Health and Disability Ethics Committees Ministry of Health 1 The Terrace, PO Box 5013 Wellington, 6011 New Zealand
Harry, Rachel Lampen-Smith, Alex Nancy Ray-Chaudhuri, Dominic Sekra, Anurag Shaik, Riaz
George, Jacob (40622)
Westmead Hospital Storr Liver Unit Hawkesbury Road Westmead, NSW 2145 Australia
Central: Monash Institute of Medical Research Southern Health Human Research and Ethics Committee 246 Clayton Road Clayton, VIC 3168 Australia
Douglas, Mark William Kwan, Vu Phuong Liddle, Christopher Lin, Rita Ong, Adrian Teck Leng Phung, Thuc Nghi Samarasinghe, Dev Amrit Vongsuvanh, Roslyn van der Poorten, David
Gordon, Stuart (38627)
Henry Ford Health System K-7 2799 West Grand Blvd Detroit, MI 48202 United States
Local: Henry Ford Health System Institutional Review Board CFP-046 2799 West Grand Blvd Detroit, MI 48202 United States
Hanschu, Inge Maria Moeller, Matthew Schairer, Jason Nicholas Tang, Jeffrey Christian Yudovich, Allen
13
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hanson, John (19986)
Charlotte Gastroenterology and Hepatology, PLLC Suite 208 2015 Randolph Road Charlotte, NC 28207 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Lawson, Aimee M Mohanty, Sanjib P Prendiville, Simon S Roddey Jr., John Gardiner R Scholz, David G Stone, Eric E Wilson, Jason A
Hezode, Christophe (44318)
CHU Henri Mondor Service d'Hepato-Gastoenterologie 51 Avenue du Marechal de Lattre de Tassigny Creteil, 94010 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Borghi-Scoazec, Giovanna Mallat, Ariane Varaut, Anne
14
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hinrichsen, Holger (43524)
Zentrum Kiel Leberstudienzentrum Kiel Preetzer Chaussee 134 Kiel, 24146 Germany
Central: Medizinische Hochschule Hannover Ethik-Komission - OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany Local: Ethikkommission der Medizinischen Fakultaet der Christian Albrechts Universitaet zu Kiel Schwanenweg 20 Kiel, 24105 Germany
Schroeder, Michael
Horvath, Gabor (39408)
Budai Hepatologiai Centrum Egry Jozsef u. 1-3 Budapest, 1111 Hungary
Central: Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga Medical Research Council Ethics Committee for Clinical Pharmacology Arany Janos u 6-8 Budapest, 1051 Hungary
Tolvaj, Gyula
15
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hunyady, Bela (37406)
Kaposi Mor Oktato Korhaz Hepatologiai Szakendeles Tallian Gyula u. 20-32 Kaposvar, 7400 Hungary
Central: Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga Medical Research Council Ethics Committee for Clinical Pharmacology Arany Janos u 6-8 Budapest, 1051 Hungary
Haragh, Attila Szinku, Zsolt
Jackson, Daniel (42362)
Digestive Health Specialists of the South 480 Honeysuckle Road Dothan, AL 36305 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Williams, Carol
16
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Klinker, Hartwig (15819)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Universitaetsklinikum Wuerzburg Medizinische Klinik und Poliklinik II Zentrum Infektiologie DGI Oberduerrbacher Str. 6 Wuerzburg, 97080 Germany
Central: Medizinische Hochschule Hannover Ethik-Komission - OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany Local: Universitaetsklinikum Wuerzburg Ethik-Kommission bei der Medizinischen Fakultaet Institut fuer Pharmakologie und Toxikologie Versbacher Str. 9 Wuerzburg, 97078 Germany
Schulze, Petra Wiebecke, Susanne
17
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Kowdley, Kris (38934) (Replaced by Wang, Chia [49531])
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Virginia Mason Medical Center MS: C3-GAS 1101 9th Avenue Seattle, WA 98101 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Cardona-Gonzalez, Lupita Gelinas, Katharyn Kanwar, Pushpjeet Lee, Maximilian Mooney, Jody C Pierce, Tracey Shah, Nihar Shaw, Cheryl Siddique, Asma Siekas, Lacey Wagenaar, Rebecca M. Rankin Wang, Chia C
18
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Kramer, Ludwig (37572)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
LKH Lainz Krankenhaus Hietzing mit neurologischem Zentrum Rosenhuegel 1. Med. Abteilung mit Gastroenterologie Wolkersbergenstrasse 1 Vienna, 1130 Austria
Central: Ethics Committee of the Medical University of Graz LKH-Universitaetsklinikum Eingangsgebaeude, 3.OG Auenbruggerplatz 2 Graz, 8036 Austria Local: LKH Lainz Ethikkommission der Stadt Wien Schnirchgasse 12/2, Stiege 2, 1 Stock Vienna, 1030 Austria
Nitsche, Lisa-Marie Rosenbeiger, Martha Wunsch, Peter
19
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Laferl, Hermann (46998)
SMZ-Sud-Kaiser-Franz-Josef-Spital der Stadt Wien 4. Medizinische Abteilung Innere Medizin Kundratstrasse 3 Vienna, 1010 Austria
Local: Ethikkommission der Stadt Wien Stiege 2, 1. Stock Schnirchgasse 12/2 Vienna, 1030 Austria Central: Ethics Committee of the Medical University of Graz LKH-Universitaetsklinikum Eingangsgebaeude, 3.OG Auenbruggerplatz 2 Graz, 8036 Austria
Kitzberger, Reinhard
Lannergard, Anders (45266)
Uppsala University Hospital Dept. of Infectious Diseases Uppsala, 751 85 Sweden
Central: Regionala etikprovningsnamnden i Stockholm FE 289 Stockholm, 171 77 Sweden
Ljunghill Hedberg, Anna Nystrom Rosander, Christina
20
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Lawitz, Eric (37388)
Texas Liver Institute, American Research Corporation 607 Camden Street San Antonio, TX 78215 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Castillo, Maria Theresa Coste, Angela M France, Michael R Freeman-Trudo, Joni Leann Galley, Samantha Macaitis, JJ Membreno, Fernando E Poordad, Fred F Trevino-Garcia, Veronica
Lucey, Michael (38625)
University of Wisconsin Hospital and Clinics H6/517 CSC, MC 5124 600 Highland Avenue Madison, WI 53792-5124 United States
Local: Western Institutional Review Board (WIRB) 1019 39th Avenue SE Puyallup, WA 98374 United States
Agarwal, Parul Cervantes, Lisa L Evans, Virginia Glasser, Annette Kennedy, G Patrice Musat, Alexandru Rice, John Said, Adnan
Magenta, Lorenzo (47653)
Fondazione Epatocentro Ticino, SA Via Soldino, 5 Lugano, 6900 Switzerland
Local: Comitato Etico Cantonala c/Ufficio di Sanita Vio Orico 5 Bellinzona, 6501 Switzerland
Balmelli, Manuela Bihl, Florian Cerny, Andreas Gurtner, Vanina Moriggia, Alberto Robatto, Antonella Terziroli, Benedetta
21
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Makara, Michael (Mihaly) (45300)
Egyesitett Szent Istvan es Szent Laszlo Korhaz Rendelointezet Kozponti Felnott Szakrendelo Albert Florian ut 5-7 Budapest, 1097 Hungary
Central: Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga Medical Research Council Ethics Committee for Clinical Pharmacology Arany Janos u 6-8 Budapest, 1051 Hungary
Sulyok, Mihaly Szlavik, Janos
Marcellin, Patrick (44365)
Hopital Beaujon Service d'Hepatologie INSERM CRB3-U773 100 Boulevard du General Leclerc Clichy, 92110 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Asselah, Tarik Aurieres-Maders, Christine Boyer, Nathalie Castelnau, Corrine Giuily, Nathalie Pouteau, Michele Sitruk, Veronique
22
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Mauss, Stefan (15494)
Dres. S Mauss G Schmutz, P Hegener, C Athmann, Duesseldorf Gemeinschaftspraxis Grafenberger Allee 128a Duesseldorf, 40237 Germany
Local: Ethik-Kommission der Aerztekammer Nordrhein Tersteegenstrasse 9 Duesseldorf, 40474 Germany Central: Medizinische Hochschule Hannover Ethik-Kommission OE 9515 Carl-Neuberg-Strasse 1 Hannover, 30625 Germany
Athmann, Christoph Hegener, Petra Schmutz, Guenther
Moradpour, Darius (47165)
Centre Hospitalier Universitaire Vaudois BU44/07 Rue du Bugnon 44 Lausanne, 1011 Switzerland
Local: Commission d'Ethique de la Recherche Clinique de la Faculte de Biologie et de Medecine de l'Universite de Lausanne Cemin des Falaises Lausanne, 1005 Switzerland
Buyse, Sophie Goerig, Christopher Guirgis, Marianne
23
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Muellhaupt, Beat (45610)
University Hospital Zurich Klinik fuer Gastroenterologie und Hepatologie Raemistrasse 100 Zurich, 8091 Switzerland
Local: Kantonale Ethikkommission Zurich Stampfenbachstrasse 121 Zurich, 8090 Switzerland
Biedermann, Luc Haller, Yeri Kuntzen, Thomas
Mutimer, David (47008)
University Hospitals Birmingham NHS Queen Elizabeth Hospital 3rd Floor, Nuffield House Edgbaston Birmingham, B15 2TH United Kingdom
Central: NRES Committee Research Health Authority London Bridge Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Elsharkawy, Ahmed Holt, Andrew Htun Oo, Ye Rowe, Ian
Nelson, David (38624)
University of Florida Hepatology Research at CTRB 2004 Mowry Road Gainesville, FL 32610 United States
Local: Western Institutional Review Board (WIRB) 1019 39th Ave. SE Puyallup, WA 98374 United States
Bauer, Angela Marie Cabrera, Roniel Clark, Virginia Catherine Firpi-Morell, Roberto J Gunnett, Amy Michelle Horne, Patrick Michael Martin, Angela Bauer Mills, Rennie Marie Morelli, Giuseppe (Joesph) Peter, Joy Anne
24
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Norkrans, Gunnar (45264)
Sahlgrenska University Hospital Dept. of Infectious Diseases Byggnad IK Osra Sjuhuset Smorslottsgatan 1 Gothenburg, 416 85 Sweden
Central: Regionala etikprovningsnamnden i Stockholm FE 289 Stockholm, 171 77 Sweden
Eilard, Anders Lagging, Martin Lindh, Magnus Wejstal, Rune Westin, Johan
Nunes, Frederick (16516)
Penn Gastroenterology at Pennsylvania Hospital Gastroenterology 4th Floor 230 W. Washington Square Philadelphia, PA 19106 United States
Local: University of Pennsylvania Office of Regulatory Affairs, IRB Suite 301 South 3624 Market Street Philadelphia, PA 19104 United States
Porat, Gail Shen, Xinying
Nyberg, Lisa (45260)
Kaiser Permanente Hepatology Research 3rd Floor 4650 Palm Avenue San Diego, CA 92154 United States
Local: Kaiser Permanente Southern California IRB 2nd Floor 393 East Walnut St. Pasadena, CA 91188 United States
Farb, Brian S Nyberg, Anders H Rathbun, Robert A
25
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Parruti, Giustino (47139)
Azienda USL Pescara - Presidio Ospedaliero di Pescara Unita Operativa di Malattie Infettive e Tropicali Via Fonte Romana n. 8 Pescara, 65126 Italy
Local: Comitato Etico Provinciale Chieti e Pescara Comitato Etico, Universita degli studie G. d'Annunzio di Chieti-Pescara e ASL di Laciano-Vasto-Chieti, Segreteria Tecnico-Amministrativa Via dei Vestini 29B Chieti, 66100 Italy
Cacciatore, Pierluigi Sozio, Federica Ursini, Tamara
Poleynard, Gary (45261)
Digestive Health Specialists, PA Suite 200 2025 Frontis Plaza Boulevard Winston-Salem, NC 27103 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Barton, Gregory Allen Bray, William Charles Long, Ashley Holdren
Poliquin, Marc (40549)
Clinique Medicale L'Actuel Suite 1130 1001 Boulevard Maisonneuve East Montreal, QC H2L 4P9 Canada
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Huchet, Emmanuelle Lavoie, Stephane Longpre, Daniele Thomas, Rejean Trottier, Benoit Vezina, Sylvie
26
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Ramgopal, Moti (33226)
Midway Immunology and Research Center 356 East Midway Road Fort Pierce, FL 34982 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Collin, Berjan Jacobs, Brenda
Roberts, Stuart (40282)
The Alfred Hospital Gastroenterology Department Commercial Road Melbourne, VIC 3004 Australia
Local: The Alfred Hospital Human Research Ethics Committee Commercial Road Melbourne, VIC 3004 Australia
Gordon, Adam Gory, Ilana Kemp, William Kitson, Matthew
Runnels, John (40526)
Gastrointestinal Associates, P.A. dba Tarheel Clinical Research LLC Suite 203 1421 North State Street Jackson, MS 39202 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Gregg, Tina M Long, Billy W McDavid, James P
Rustgi, Vinod (9174)
Metropolitan Research Suite 209 3301 Woodburn Road Annandale, VA 22003 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Bian, Rakhvinder K Keller, Andrea Lynn Pham, Huong (Jane) T Rassulova, Svetlana Sackett, Beth M Schultz, Beth M Yankouskaya, Maria
*Investigator number is listed as (09174) in the clinical database.
27
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Ryder, Stephen (42765)
University Hospital Queen's Medical Centre Nottingham Digestive Diseases Centre and Biomedical Research Unit Nottingham University Hospitals NHS Trust Derby Road, Queens Medical Centre Campus Nottingham, NG7 2UH United Kingdom
Central: NRES Committee London - City and East South West REC Centre, Level 3, Block B Whitefriars, Lewins Mead Bristol, BS1 2NT United Kingdom
James, Martin Ramappa, Vidyasagar Thomas, James
Santoro, John (42368)
AGA Clinical Research Associates, LLC 3205 Fire Road Egg Harbor Township, NJ 08234 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Kaufman, Barry P Rosman, Gary A Spaar, Joseph L Stevens, Theresa M
Shafran, Stephen (5602)
University of Alberta Hospital WMC 2E4.14 8440-112 Street Edmonton, AB T6G 2B7 Canada
Local: Health Research Ethics Board University of Alberta 308 Campus Tower 8625-112 Street Edmonton, AB, T6G 0K8 Canada
Chiu, Isabelle Cooper, Ryan Doucette, Karen Kunimoto, Dennis Rosser, Stuart Smith, Stephanie Tyrrell, Lorne
*Investigator number is listed as (05602) in the clinical database.
28
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Shiffman, Mitchell (40537)
Liver Institute of Virginia Bon Secours St. Mary's Hospital of Richmond, Inc. Suite 313 12720 McManus Boulevard Newport News, VA 23602 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Alexander, Philip C Coleman, Rochelle Hamlin, Tashara James, Amy Long, April Tipps, Suzette Townsend, Denisha Vollum, Susan Williams, Shanay
Sievert, William (46995)
Monash Institute of Medical Research Department Gastroenterology Southern Health 246 Clayton Road Clayton, VIC 3168 Australia
Central: Monash Institute of Medical Research Southern Health Human Research and Ethics Committee 246 Clayton Road Clayton, VIC 3168 Australia
Choy, Matthew Doyle, Adam Goldberg, Rimma Ket, Shara Knight, Virginia Pianko, Stephen Shelton, Edward Tabatabai, Shireen Ye, Bei
Sigal, Samuel (39549)
NYU School of Medicine NYU Langone Medical Center HCC 4J 530 First Avenue New York, NY 10016 United States
Local: NYU School of Medicine NYU Langone Medical Center IRB Human Research Protection Program, 6th Floor One Park Avenue New York, NY 10016 United States
Hahambis, Thomas Park, James Reyes, Flordelis
29
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Sola Lamoglia, Ricardo (40857)
Hospital Parc de Salut del Mar Seccion Hepatologia, Servicio de Digestivo Edif. de consultas externas, letra A Passeig Maritim, 25-29 Barcelona, 08003 Spain
Local: Hospital Parc de Salut del Mar CEIC Secretaria Tecnica CEIC-IMAS 1 Planta C/Dr. Alguader, 88 - Edifici PRBB Barcelona, 08003 Spain Central: CEIC Hospital Parc de Salut del Mar Secretaria Tecnica CEIC-IMAS 1a Planta C/ Dr. Aiguader, 88 - Edifici PRBB Barcelona, 08003 Spain
Canete Hidalgo, Nuria Carrion Rodriguez, Jose Antonio Coll Estrada, Susana Garcia Retortillo, Montserrat
Stauber, Rudolf (39547)
Landeskrankenhaus Universitaetsklinikum Graz Department of Internal Medicine Division of Gastroenterology and Hepatology Auenbruggerplatz 15 Graz, 8036 Austria
Central: Ethics Committee of the Medical University of Graz LKH-Universitaetsklinikum Eingangsgebaeude, 3.OG Auenbruggerplatz 2 Graz, 8036 Austria
Douschan, Philipp Spindelboeck, Walter
30
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Sulkowski, Mark (35827)
Johns Hopkins University Medical Institutions Falls Concourse, Suite 412 10751 Falls Road Lutherville, MD 21093 United States
Local: Johns Hopkins University School of Medicine IRB, Office of Human Subjects Research Reed Hall, Suite B-130 1620 McElderry Street Baltimore, MD 21205-19118 United States
Brinkley, Sherilyn McArthur, Julie Melia, Michael
Sullivan, James (12538)
Parkway Medical Center 1160 Huffman Road Birmingham, AL 35215 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
King, Duane W
Tam, Edward (42420)
LAIR Centre Suite 305 750 West Broadway Vancouver, BC V5Z 1H2 Canada
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Viljoen, Mark
31
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Tran, Albert (47112)
CHU de Nice Pole de reference Hepatite C, Niveau -2 Hopital de l'Archet 2 151 Route de Saint Antoine de Ginestiere - BP 3079 Nice, 06202 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Foti, Pauline Truchi, Regine
Ustianowski, Andrew (47010)
North Manchester General Hospital Infectious Diseases Research Department 2nd Floor J Block Delaunays Road, Crumpsall Manchester, M8 5RB United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Baxter, Joanne Uriel, Alison Jane Van Helsema, Clare
Vierling, John (38851)
Advance Liver Therapies St. Lukes Health Baylor College of Medicine Medical Center, Suite 1505 6620 Main Street Houston, TX 77030 United States
Local: Biomedical Research Alliance of New York, LLC Biomedical Research Alliance of New York Suite 210 1981 Marcus Ave. Lake Success, NY 11042 United States
Dietrich, Beth Hollinger, F Blaine Jalal, Prasun Kumar Sood, Gagan K Stribling, Rise J Sussman, Norman L Westergren, Paula
32
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Wang, Chia (49531) (Replaced Kowdley, Kris [38934]) Weber, Jr., Fredrick (42372)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Virginia Mason Medical Center MS: C3-GAS 1101 9th Avenue Seattle, WA 98101 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Ackermann, Sarah Cardona-Gonzalez, Lupita Gelinas, Katharyn Mooney, Jody C Shaw, Cheryl Siddique, Asma
TriHealth, Inc. Suite 200 & 300 10600 Montgomery Road Cincinnati, OH 45242 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Bawtenheimer, Vivian Ann Bell, Grace Ellen Firsich, Nancy M Hoffman, Laura Lea Peck, Allan Lawrence
33
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Wedemeyer, Hans (40785)
Medizinische Hochschule Hannover Abteilung fuer Gastroenterologie, Hepatologie, Endokrinologie Carl-Neuberg-Strasse 1 Hannover, 30625 Germany
Central: Medizinische Hochschule Hannover Ethik-Kommission OE 9515 Carl-Neuberg-Strasse 1 Hannover, 30625 Germany Local: Medizinische Hochschule Hannover Ethik-Kommission OE 9515 Carl-Neuberg-Strasse 1 Hannover, 30625 Germany
Cornberg, Markus Deterding, Katja Hoener zu Siederdissen, Christoph Maasoumy, Benjamin Manns, Michael Peter Port, Kerstin
Weiland, Ola (45207)
Karolinska University Hospital Huddinge, Div. of Infectious Diseases 173 Stockholm, 141 86 Sweden
Central: Regionala etikprovningsnamnden i Stockholm FE 289 Stockholm, 171 77 Sweden
Aleman, Soo Lindahl, Karin
34
ABT-450/r/ABT-267, ABT-333 M11-646 Clinical Study Report – Final R&D/14/1302
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Zeuzem, Stefan (40784)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Klinikum der Johann Wolfgang Goethe Universitaet Innere Medizin I Theodor-Stern-Kai 7 Frankfurt, 60590 Germany
Local: Klinikum der Johann Wolfgang Goethe Universitaet Ethik-Kommission des Fachbereichs Medizin Haus 1 Theodor-Stern-Kai 7 Frankfurt, 60590 Germany Central: Medizinische Hochschule Hannover Ethik-Komission – OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany
Buslau, Anna Fitting, Daniel Gerber, Ludmila Kofler, Stefan Reichardt, Adriane Sprinzl, Kathrin Andrea Tal, Andrea Welzel, Tania
35
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
16.1__4
Investigators and Other Important Participants in the Study
16.1__4.1
List and Description of Investigators
1
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Afdhal, Nezam (9190) *Investigator number is listed as (09190) in the clinical database.
Beth Israel Deaconess Medical Center Liver Research Center Suite 4A 110 Francis St Boston, MA 02215 United States
Local: Beth Israel Deaconess Medical Center Committee on Clinical Investigations (CCI) 330 Brookline Avenue Boston, MA 02215 United States
Cohen, Eric Colagreco, Joseph P. Curry, Michael P. Ghaziani, Tahereh Lai, Michelle Malik, Raza Rourke, Amy E Taskaya, Tiffany A.
Agarwal, Kaushik (Kosh) (44408)
University College London Hospitals NHS Foundation Trust Institute of Liver Studies Cheyne Wing, 3rd floor Denmark Hill London, SE5 9RS United Kingdom
Central: NRES Committee London – London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Al-Chalabi, Thawab Audimoolam, Vinod Barnabas, Ashley Carey, Ivana Verma, Suman
Aggarwal, Avanish (36888)
Internal Medicine Specialists 3885 Oakwater Circle Orlando, FL 32806 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Bhaskar, Sudhir Kumar Jolly, Walter Mike
2
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Aguilar, Humberto (42730)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Louisiana Research Center, LLC Suite 318 1453 East Bert Kouns Shreveport, LA 71105 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Barber Stephens, Brandi Burgoyne, Michelle Anne Carroll, Beverly Chambers, Winde Davis, Jeremy Payne Dies, David Frank Giddings, Stacy Hatfield, Deborah Hebert, Heather Andrina Hobley, James C. Johnson, Lawrence Webster Miller, Seth Wayne Mohan, Sathya Narayan Raj Jagan Paskey, Stacy Philips, David Miller Poch, Arthur Lewis Provenza, John Mark Rimmer, Jr., Douglas Edward Robinson, Thomas Russell Salter, Robert Matthew White, John Michael
3
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Albrecht, Helmut (45262) (Site did not enroll)
University of South Carolina School of Medicine Div. of Infectious Diseases Suite 502 2 Medical Park Columbia, SC 29203 United States
Local: Palmetto Health IRBs 5 Richland Medical Park Drive Columbia, SC 29203 United States
Ahuja, Divya Dash, Sangita Horvath, Joseph Alexander Weissman, Sharon
Alves Oliveira, Celia Maria Moreira (46970) *Investigator is listed as "Alves Oliveira, Celia" in the clinical database.
Centro Hospitalar du Baixo Vouca, EPE Servico de Infecciologia Hospital de Aveiro Avenida Artur Ravara Aveiro, 3814-501 Portugal
Central: CEIC – Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Coutinho, Daniel Freitas, Filomena Maio, Antonio Velez, Jorge
Angarano, Gioacchino (47138)
Azienda Ospedaliero Universitaria Consorziale Policlinico Consorziale di Bari U.O.C. Malattie Infettive Piazza Giulio Cesare, 11 Bari, 70124 Italy
Local: Azienda Ospedaliero Universitaria Consorziale Policlinico Consorziale di Bari Comitato Etico Piazza Giulio Cesare, 11 Bari, 70124 Italy
Milella, Michele
4
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Ankoma-Sey, Victor (45466)
Liver Associates of Texas, P.A. Suite 225 6410 Fannin Street Houston, TX 77030 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Egwim, Chukwuma Tran, Ky-Dieu Zela, Scott
Bakulin, Igor (46993)
LLC MedElitConsulting 2/2, Pobedy sq. Moscow, 121170 Russian Federation
Local: LLC MedElitConsulting Local Etics Committee 2/2, Pobedy sq. Moscow, 121170 Russian Federation
Abdulaeva, Hanika Galushko, Mikhail Sandler, Yulia
Central: Ethics Counsel under the Ministry of Healthcare 3, Rakhmanovskiy pereulok Moscow, 127994 Russian Federation
5
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Baumgarten, Axel (34085)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
mib Dienstleistung GmbH Seestrasse 13 Berlin, 13353 Germany
Local: Landesamt fuer Gesundheit und Soziales Ethik-Kommission des Landes Berlin Fehrbelliner Platz 1 Berlin, 10707 Germany
Ingiliz, Patrick Krznaric, Ivanka Weinberg, Gorden
Central: Ethik-Kommission des Fachbereichs Medizin der Johann Wolfgang Goethe-Universitaet Haus 1 Theodor-Stern-Kai 7 Frankfurt, 60590 Germany Bourliere, Marc (44317)
Hopital Saint Joseph Department of Hepato Gastroenterology 26 Boulevard de Louvain Marseilles, 13285 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Ansaldi, Christelle Ben Ali, Souad
6
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Brehm Christensen, Peer (47652)
Odense Universitets Hospital Department of Infectious Diseases Sdr. Boulevard 29 Odense C, 5000 Denmark
Central: De Videnskabsetiske Komiteer for Region Midtjylland Regionssekretariatet, Juridisk Kontor Skottenborg 26 Viborg, 8800 Denmark
Christensen, Jacob Soholm Hornstrup, Tinne
Brown, Ashley (47009)
St. Marys Hospital Liver and Anti-Viral Unit 10th Floor, Queen Elizabeth The Queen Mother Building (QEQM) Praed Street London, W2 1NY United Kingdom
Central: NRES Committee London – London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Main, Janice Nieddu, Paolo Saleh, Ghada Selvapatt, Nowlan
7
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Calleja, Jose Luis (44372) *Investigator is listed as "Calleja Panero, Jose" in the clinical database.
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hospital Universitario Puerta de Hierro Majadahonda Planta 3 Digestivo C/Manuel de Falla, No. 1 Majadahonda, Madrid, 28222 Spain
Central: Hospital Universitario Puerta de Hierro Majadahonda CEIC C/Manuel de Falla, 1 Spain
Martinez, Jose Luis de la Revilla, Juan
Local: Hospital Universitario Puerta de Hierro Majadahonda CEIC C/Manuel de Falla, 1 Majadahonda (Madrid), 28220 Spain Canva, Valerie (48391)
CHRU de Lille, Hopital Claude Huriez Service d'Hepato-Gastro-Enterologie 1 Place de Verdun – Rue Polonovski Lille Cedex, 59037 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Cannesson, Amelie Deltenre, Pierre Dharancy, Seastien Lassailly, Guillaume Louvet, Alexandre Mathurin, Philippe
8
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Carvalho, Armando (47041)
Centro Hospitalar e Universitario de Coimbra, EPE Servico de Medicina III Avenida Bissaya Barreto Coimbra, 3000-075 Portugal
Central: CEIC – Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Correia, Lurdes Silva, Raquel Simao, Adelia
Cooper, Curtis (21909)
Ottawa Hospital 501 Smyth Road Ottawa, ON K1H 8L6 Canada
Local: Ottawa Hospital Research Ethics Board Civic Campus, LOEB Building 725 Parkdale Avenue Ottawa, ON K1Y 4E9 Canada
Garber, Gary E. Hodgins, Michael Lee, Craig
de Knegt, Robert (48121)
Erasmus Medisch Centrum s-Gravendijkwal 230 Rotterdam, 3015 CE Netherlands
Central: Academisch Medisch Centrum Medisch Ethische Commissie Meibergdreef 9 Amsterdam, 1105 AZ Netherlands
Koning, Ludi Maan, Raoel van der Meer, Adriaan Johannes Pieter
9
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Desmond, Paul (46996)
St. Vincents Hospital Melbourne Department of Gastroenterology Level 4 Daly Wing 35 Victoria Parade Fitzroy, Melbourne, VIC 3065 Australia
Central: St. Vincents Hospital Melbourne Human Research Ethics Committee D 41 Victoria Parade Fitzroy, Melbourne, VIC 3065 Australia
Bell, Sally Burns, Gareth Holmes, Jacinta Alison Hong, Thai Thompson, Alexander J. V. Yi Mei, Swee Lin Chen
Diago Madrid, Moises (40766)
Hospital Quiron de Valencia Unidad de Hepatologia Servicio de Aparato Digestivo Avenida Blasco Ibanez, 10 Valencia, 46014 Spain
Central: Hospital Universitario Puerta de Hierro Majadahonda CEIC C/Manuel de Falla, 1 Majadahonda (Madrid), 28220 Spain
Moreno Martin, Maria Luisa Perez Anton, Celia
Local: Hospital de la Ribera CEIC Ctra. Corbera, Km 0 Alzira (Valencia), 46600 Spain
10
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Di Bisceglie, Adrian (38937)
Saint Louis University Gastroenterology and Hepatology Clinical Research Unit 2nd floor 3545 Lafayette Avenue St. Louis, MO 63104 United States
Local: Saint Louis University Institutional Review Board Caroline Building C110 3556 Caroline Street St. Louis, MO United States
Bacon, Bruce Raymond Befeler, Alex S. Campbell, Shirley Rao, Savitha Shelley, Nancy L. Tetri, Brent A. Thompson, Judy A. Wilkins, Rebecca F. Wriston, Kristina L.
Dusheiko, Geoffrey (42783)
The Royal Free Hospital Division of Medicine Centre for Hepatology Pond Street London, NW3 2QG United Kingdom
Central: NRES Committee London – London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Burney, Tabinda Rosenberg, William Trembling, Paul
Epstein, Michael (12649)
Investigative Clinical Research Suite 204 621 Ridgely Avenue Annapolis, MD 21401 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Medeiros, Lisa Ann
11
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Etzkorn, Kyle (9953) *Investigator number is listed as (09953) in the clinical database.
Borland-Groover Clinic Suite 301 4800 Belfort Road Jacksonville, FL 32256 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Corregidor, Ana M. DiTeodoro, Linda Ann Gopal, Vikram D. Nieto, Jose
Everson, Gregory (37869)
University of Colorado Denver and Hospital AOP 7th floor 1635 Aurora Court Aurora, CO 80045 United States
Local: Western Institutional Review Board (WIRB) 3535 Seventh Avenue Southwest Olympia, WA 98502-5010 United States
Bambha, Kiran Bhatt, Asmeen Biggins, Scott Burton, James R. Forman, Lisa Henrichs, Kelly Pratt, Lindsay Rosen, Hugo Tise, Sarah
Feld, Jordan (43189)
Toronto Western Hospital Liver Centre 6B Fell Pavilion 399 Bathurst Street Toronto, ON M5T 2S8 Canada
Local: University Health Network Research Ethics Board 10th Floor, Suite 1056 700 University Avenue Toronto, M5G 1Z5 Canada
Abu-Amara, Mahmoud Cruz Pereira, Oscar Janssen, Harry Juan, Joshua Shah, Hemant Wong, David
12
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Freilich, Bradley (22854)
Kansas City Research Institute Suite 430 6675 Holmes Road Kansas City, MO 64131 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Kissinger, Janay A.
Gaeta, Giovanni (45531)
University of Naples Unita Epatiti Virali Acute e Coniche Via S. Pansini, 5 Naples, 80131 Italy
Local: Comitato Etico dell A.O. Univ della sconda Comitato Etico dell'Azienda Ospedaliera Universitaria della Seconda Universita Degli Studi di Napoli Via Costantinopoli 104 Naples, 80138 Italy
Brancaccio, Giuseppina Marchese, Valentina Rizzo, Viviana
Galambos, Michael (13082)
Digestive Healthcare of Georgia Suite 4085 95 Collier Road Atlanta, GA 30309 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Sims, Mark A.
13
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Galler, Greg (32432)
Kelsey Research Foundation Suite 660 5615 Kirby Drive Houston, TX 77005 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Snyder III, Ned
Goff, John (4253)
Rocky Mountain Gastroenterology Associates 7000 West Colfax Avenue Lakewood, CO 80215 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Bilir, Bahri M. Hightower, Lynn M. Jain, Rajesh Mackenzie, Scott H. Reveille, Robert Matthew
Hassanein, Tarek (16471)
Southern California Research Center Suite 101 131 Orange Avenue Coronado, CA 92118 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Biando, Karel Couturier, Thomas A. Fuchs, Tyler Harvey, Samantha T. Hassanein, Roukaya Hefner, Anna Marie Icban, Maria C Mendoza, Adriana Meza, Lauren Elizabeth Monson, Petrea Reshamwala, Preeti A. Vargas, Chanel
14
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Hobstova, Jirina (44345)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Fakultni Nemocnice v Motole Klinika infekcnich chorob V Uvalu 84 Prague 5, 150 06 Czech Republic
Local: Fakultni Nemocnice v Motole Multicentricka a lokalni eticka komise V Uvalu 84 Prague 5, 150 06 Czech Republic
Novak, Jan
Central: Eticka Komise Fakultni nemocnice Brno Jihlavska 20 Brno, 625 00 Czech Republic Husa, Petr (42721) (Site did not enroll)
Fakultni Nemocnice Brno Klinika infekcnich chorob Jihlavska 20 Brno, 625 00 Czech Republic
Local: Fakultni Nemocnice Brno Local Ethics Committee Jihlavska 20 Brno, 625 00 Czech Republic
Slesinger, Pavel
Central: Fakultni Nemocnice Brno Local Ethics Committee Jihlavska 20 Brno, 625 00 Czech Republic
15
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Isakov, Vasiliy (32887)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Clinic of Scientific and Research Institute of Nutrition RAMS 21, Kashirskoe shosse Moscow, 115446 Russian Federation
Local: Clinic of Scientific and Research Ethics Committee Insitute of Nutrition RAMS 21, Kashirskoe shosse Moscow, 115446 Russian Federation
Morozov, Sergey Vladimirovich
Central: Ethics Counsel under the Ministry of Healthcare 3, Rakhmanovskiy pereulok Moscow, 127994 Russian Federation Ivashkin, Vladimir (32891)
Moscow State Medical University n.a. I.M. Sechenov Clinic of Propedeutics of Internal Diseases, Gastroenterology and Hepatology n.a. V.H. Vasilenko 1, Build. 1, Pogodinskaya str. Moscow, 119435 Russian Federation
Local: Interacademic Ethics Committee Building 2 37, Gagarinskiy pr. Moscow, 119002 Russian Federation
Fedosyina, Ekaterina Shauki, Ondos
Central: Ethics Counsel under the Ministry of Healthcare 3, Rakhmanovskiy pereulok Moscow, 127994 Russian Federation 16
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Jacobson, Ira (37740)
Weill Medical College of Cornell University 4th Floor 1305 York Avenue New York, NY 10021 United States
Local: Weill Medical College of Cornell University Institutional Review Board 1st floor 407 East 61st Street New York, NY 10065 United States
Carasso, Monique Cervini, Christine Kumar, Sonal Marks, Kristen Olson, Mary Opong, Adomah
Jayakumar, Saumya (47442)
University of Calgary Liver Unit 5E31 TRW Building 3280 Hospital Drive, NW Calgary, AB T2N 4Z6 Canada
Local: University of Calgary Conjoint Health Research Ethics Board (CHREB), Office of Medical Bioethics Research Services Office, Energy Resource Research Building Suite N 140, 3512 33rd Street NW Calgary, AB T2L 2A6 Canada
Burak, Kelly Coffin, Carla Eksteen, Bertus Lee, Samuel S. Myers, Robert Paul Swain, Mark
17
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Jensen, Donald (40283) (Replaced by Reau, Nancy [48135])
University of Chicago Medical Center MC-7120 5841 S. Maryland Avenue Chicago, IL 60637 United States
Local: University of Chicago The Institutional Review Board 5751 S. Woodlawn Avenue McGiffert Hall, 2nd Floor AMB-S138, MC1108 Chicago, IL 60637 United States
Aronsohn, Andrew Arrieta, Rosario L. Komar-Samardzija, Melanie Newsome, Maria A. Reau, Nancy Reddy, K. Gautham Silver, Audrey I. Te, Helen S. Williams, Monique L.
Koval, George (2965)
The Oregon Clinic – P.C. Gastroenterology West Suite 300 9701 Southwest Barnes Road Portland, OR 97225 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Ader, Vesna Burg, Erica Caine, Amy J. Eisen, Glenn Forsyth, Emily Grunkemeier, David M.S. Hartshorn, Anna Kaynard, Alan H. Lee, Brent Lewis, Shannon K. Maciolek, Izabela Owens, Michael M. Sleven, Rodger A. Vallejos, Cristian R. Weprin, Jeffrey J. Wong, Banny
18
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Kowdley, Kris (38934) (Replaced by Wang, Chia [49531])
Virginia Mason Medical Center 1100 Ninth Avenue Seattle, WA 98101 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Ackermann, Sarah Cardona Gonzalez, Lupita Gelinas, Katharyn Kanwar, Pushpjeet Lee, Maximilian Mooney, Jody C. Pierce, Tracey Shah, Nihar Shaw, Cheryl Siddique, Asma Siekas, Lacey Wagenaar, Rebecca M. Rankin Wang, Chia C.
Kwo, Paul (37868)
Indiana University IB327 975 West Walnut Street Indianapolis, IN 46202-5121 United States
Local: Western Institutional Review Board (WIRB) Suite 120 1019 39th Avenue Southeast Puyallup, WA 98374-2115
Lacerda, Marco Yoo, Hwan
19
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Laursen, Alex (40364) (Replaced Leutscher, Peter [47651]) *Investigator is listed as "Laursen, ." in the clinical database.
Aarhus University Hospital, Skejby Department of Infectious Diseases Brendstrupgaardsvej 100 Aarhus N, 8200 Denmark
Central: De Videnskabsetiske Komiteer for Region Midtjylland Regionssekretariatet, Juridisk Kontor Skottenborg 26 Viborg, 8800 Denmark United States
Arildsen, Hanne
Lawitz, Eric (37388) (Replaced by Poordad, Fred [37739])
Alamo Medical Research 621 Camden Street, Suite 202 San Antonio, TX 78215 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Castillo, Maria Theresa Coste, Angela M. France, Michael R. Freeman-Trudo, Joni Leann Khan, Uroosa Membreno, Fernando E. Poordad, Fred F. Solitaire, Roxann Trevino Garcia, Veronica
Leutscher, Peter (47651) (Replaced by Laursen, Alex [40364])
Aarhus University Hospital, Skejby Department of Infectious Diseases Brendstrupgaardsvej 100 Aarhus N, 8200 Denmark
Central: De Videnskabsetiske Komiteer for Region Midtjylland Regionssekretariatet, Juridisk Kontor Skottenborg 26 Viborg, 8800 Denmark
Arildsen, Hanne Lund Laursen, Alex
20
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Li, Xiaoyu (45808) (Site did not enroll)
University of Florida Suite 300 4555 Emerson Street Jacksonville, FL 32207 United States
Local: Western Institutional Review Board (WIRB) 3535 Seventh Avenue Southwest Olympia, WA 98502-5010 United States
Ebuen, Benedict L. Elfvin, Kerri Munoz, Juan C.
Lok, Anna (40521)
University of Michigan Hospital 3912 Taubman Center, SPC 5362 1500 E. Med Center Drive Ann Arbor, MI 48109 United States
Local: IRBMED Room 3214, Building 520 2800 Plymouth Road Ann Arbor, MI 48109-2800 United States
Fontana, Robert Kaza, Sravanthi Oberhelman, Kelly White, Diane Wu, Elizabeth
Macedo, Guilherme (34984)
Centro Hospitalar de Sao Joao, E.P.E. Servico de Gastroenterologia Alameda Prof. Hernani Monteiro Porto, 4200-319 Portugal
Central: CEIC – Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Cardoso, Helder Lopes, Susana Marques, Marigarida Pereira, Pedro Vale, Ana Maria
21
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Martin, Paul (38652)
University of Miami Schiff Center for Liver Diseases Suite 1101 1500 NW 12th Avenue Miami, FL 33136 United States
Local: University of Miami Human Subjects Research Office (HSRO) Suite 1002 1500 NW 12th Avenue Miami, FL 33136 United States
Bhamidimarri, Kalyan Ram Levy, Cynthia O'Brien, Christopher
Mathiesen, Lars Reinhardt (8307) (Site did not enroll)
Hvidovre Hospital Department of Infectious Diseases 144 Kettegaard Alle 30 Hvidovre, 2650 Denmark
Central: De Videnskabsetiske Komiteer for Region Midtjylland Regionssekretariatet, Juridisk Kontor Skottenborg 26 Viborg, 8800 Denmark
Weis, Nina
McCormick, Aiden (47666)
St. Vincent's University Hospital Elm Park Dublin 4 Ireland
Central: St. Vincent's University Hospital Ethics and Medical Research Committee St. Vincent's Healthcare Group Limited Elm Park Dublin 4, Ireland
Chin-Tech, Vincent Elgaily, Elrayah Iqbal, Masood Ryan, John
22
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Mills, Peter (47321)
Gartnavel General Hospital Western Infirmary and Gartnavel General Hospital 1053 Great Western Road Glasgow, G12 0YN United Kingdom
Central: NRES Committee London – London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Bell, David Fox, Raymond Priest, Matthew Thomson, Emma
Morales Garza, Luis Alonso (47129) (Site did not enroll)
Accelerium S. de R.L. de C.V. Modesto Arreola No. 917 Ote Col. Centro Nuevo Leon Monterrey, C.P. 64000 Mexico
Local: Accelerium S. de R.L. de C.V. Modesto Arreola No. 917 Ote Comite de Etica en Investigacion Col. Centro Nuevo Leon Monterrey, C.P. 64000 Mexico
Morales Cerda, Jesus David
Murray, Frank (45724)
Beaumont Hospital Beaumont Road Dublin 9, Ireland
Central: St. Vincent's University Hospital Ethics and Medical Research Committee St. Vincent's Healthcare Group Limited Elm Park Dublin 4, Ireland
Cannon, Mary Harterey, Karen Iqbal, Nadeem Mohamed, Abdelhafeez S. O'Toole, Aoibhlinn Mary Pritchard, David
23
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Norris, Suzanne (47011)
St. James Hospital Hepatology/Liver Diseases (GEMS) James's Street Dublin 8, Ireland
Central: St. Vincent's University Hospital Ethics and Medical Research Committee St. Vincent's Healthcare Group Limited Elm Park Dublin 4, Ireland
El-Sherif, Omar
Orlandini, Alessandra (49178)
Azienda Ospedaliera Universitaria di Parma U.O. Malattie Infettive ed Epatologia Via Antonio Gramsci, 14 Parma, 43126 Italy
Local: Azienda Ospedaliera Universitaria di Parma Comitato Etico, Comitato Etico Unico per la Provincia di Parma Via Gramsci, 14 Parma, 43126 Italy
Boni, Carolina Negri, Elisa Sacchelli, Luca
Phillips, Raymond (37491)
Gastroenterology Group of Naples 1064 Goodlette Road Naples, FL 34102 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Amar, Sivakumar Liberski, Susan Mary Naccarato Webb, Patrice Pendelton Horner, Sally
24
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Pol, Stanislas (44319)
Groupe Hospitalier Cochin Unite Fonctionnelle Hepatologie Medicale Pole Medico-Chirugical d'HepoGastroenterologie 27 Rue du Faubourg Sant Jaques Paris Cedex 14, 75679 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Corouge, Marion Fontaine, Helene Mallet, Vincent Sogni, Philippe Trabut, Jean-Baptiste Tripon, Simona Vallet-Pichard, Anais
Poordad, Fred (37739) (Replaced Lawitz, Eric [37388]) *Investigator number is listed as (3773902) in the clinical database.
Texas Liver Institute, American Research Corporation 607 Camden Street San Antonio, TX 78215 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Castillo, Maria Theresa Coste, Angela M. France, Michael R. Freeman-Trudo, Joni Leann Khan, Uroosa Lawitz, Eric J. Membreno, Fernando E. Solitaire, Roxann Trevino Garcia, Veronica
Poulos, John (35823)
Cumberland Research Associates, LLC Suite 102 2109 Valleygate Drive Fayetteville, NC 28304 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Daignault, Thomas Daniels, Anthony Hill, Crystal Kodali, Valli P. Kumar, Arvind Parker, Elena Rys, Jill Zafirov, Dimiter
25
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Ravendhran, Natarajan (40525)
Digestive Disease Associates, PA Suite 303 4660 Wilkens Avenue Baltimore, MD 21229 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Salas, Louis A.
Reau, Nancy (48135) (Replaced Jensen, Donald [40283])
University of Chicago Medical Center MC-7120 5841 S. Maryland Avenue Chicago, IL 60637 United States
Local: University of Chicago The Institutional Review Board 5751 S. Woodlawn Avenue McGiffert Hall, 2nd Floor AMB-S138, MC1108 Chicago, IL 60637 United States
Arrieta, Rosario L. Komar-Samardzija, Melanie Newsome, Maria A. Reddy, K. Gautham Silver, Audrey I. Te, Helen S. Williams, Monique L.
Reesink, Hendrik Willem (45200) *Investigator is listed as "Reesink, Hendrik" in the clinical database.
Academisch Medisch Centrum Universiteit van Amsterdam Meibergdreef 9 Amsterdam, 1105 AZ Netherlands
Central: Academisch Medisch Centrum Medisch Ethische Commissie Meibergdreef 9 Amsterdam, 1105 AZ Netherlands
Willemse, Sophie Bertine van der Ree, Meike Henriette
Reindollar, Robert (41723)
Carolinas Center For Liver Disease Suite 100 633 Brookdale Drive Statesville, NC 28677 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Ellis, Justin D. Powell, Jesse G.
26
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Rivero Roman, Antonio (17597)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hospital Universitario Reina Sofia Unidad de Enfermedades Infecciosas Avenida Menendez Pidal, s/n Cordoba, 14004 Spain
Central: Hospital Universitario Puerta de Hierro Majadahonda CEIC C/Manuel de Falla, 1 Majadahonda (Madrid), 28220 Spain
Camacho Espejo, Angela Garcia, Milagros Jurado Jimenez, Rafael Kindelan, Jose Mari Rivero Juarez, Antonio de la Torre, Julian
Local: Hospital Universitario Reina Sofia CEIC Avenida Menendez Pidal, s/n Cordoba, 14004 Spain Rodriguez-Perez, Federico (45122)
Klinical Investigations Group, LLC Office 303 1420 Americo Salas St. Santurce, 00909 Puerto Rico
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Bigio, Johanna
27
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Romero Gomez, Manuel (44436)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hospital Universitario Nuestra Senora de Valme Servicio de Digestivo Carretera de Cadiz, Km. 548,9 Seville, 41014 Spain
Central: Hospital Universitario Puerta de Hierro Majadahonda CEIC C/ Manuel de Falla, 1 Majadahonda (Madrid), 28220 Spain
Aparcero Lopez, Reyes
Local: Hospital Universitario Nuestra Senora de Valme Comite Etico de Investigacion Clinica Carretera de Cadiz, Km. 548.9 Seville, 41014 Spain Sarmento e Castro, Rui Manuel do Rosario (47042) *Investigator is listed as "Sarmento E Castro, Rui" in the clinical database.
Hospital Joaquim Urbano Servico de Doencas Infecciosas Centro Hospitalar do Porto, EPE Rua Camara Pestana 348 Porto, 4369-004 Portugal
Central: CEIC – Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Aravjo Abrev, Migel Mendez, Josefina Silva, Ana Rita
28
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Schuchmann, Marcus (38887) (Replaced by Sprinzl, Martin [49779])
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz I. Medizinische Klinik und Poliklinik Langenbeckstrasse 1 Mainz, 55131 Germany
Local: Ethik-Kommission Landesaerztekammer Rheinland-Pfalz Deutschhausplatz 3 Mainz, 55116 Germany
Grambihler, Annette Kittner, Jens Martin Schattenberg, Joern Markus Sprinzl, Martin Franz Thieringer, Florian Rolf Zimmermann, Tim
Central: Ethik-Kommission des Fachbereichs Medizin der Johann Wolfgang Goethe-Universitaet Haus 1 Theodor-Stern-Kai 7 Frankfurt, 60590 Germany Smith, Coleman (38847) (Replaced by Zogg, Donald [81470])
Minnesota Gastroenterology, P.A Suite 120 2200 University Avenue West St. Paul, MN 55114 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Boldt, Mark Feldshon, S. David Heller, Leon (Chip) Laughlin, Casie Storrs, Gina
29
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Sprinzl, Martin (49779) (Replaced Schuchmann, Marcus [38887])
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz I. Medizinische Klinik und Poliklinik Langenbeckstrasse 1 Mainz, 55131 Germany
Local: Ethik-Kommission Landesaerztekammer Rheinland-Pfalz Deutschhausplatz 3 Mainz, 55116 Germany
Grambihler, Annette Kittner, Jens Martin Schattenberg, Joern Markus Thieringer, Florian Rolf Zimmermann, Tim
Central: Ethik-Kommission des Fachbereichs Medizin der Johann Wolfgang Goethe-Universitaet Haus 1 Theodor-Stern-Kai 7 Frankfurt, 60590 Germany Stewart, Stephen (47662)
Mater Misericordiae University Hospital Centre for Liver Disease 48 Eccles Street Dublin 7, Ireland
Central: St. Vincent's University Hospital Ethics and Medical Research Committee St. Vincent's Healthcare Group Limited Elm Park Dublin 4, Ireland
Galvin, Zita Lambert, Jack
30
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Stoehr, Albrecht (7584)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
ifi-Studien und Projekte GmbH An der Asklepios Klinik St. Georg Haus L Lohmuehlenstrasse 5 Hamburg, 20099 Germany
Local: Ethik-Kommission der Aerztekammer Hamburg Humboldtstrasse 67a Hamburg, 22083 Germany
Buggisch, Peter Matschenz, Katrin Petersen, Joerg Unger, Stefan Voelker, Katharina
Central: Ethik-Kommission des Fachbereichs Medizin der Johann Wolfgang Goethe-Universitaet Haus 1 Theodor-Stern-Kai 7 Frankfurt, 60590 Germany Strasser, Simone (38899)
Royal Prince Alfred Hospital AW Morrow Gastroenterology and Liver Centre Missenden Road Camperdown, NSW 2050 Australia
Local: St. Vincents Hospital Melbourne Human Research Ethics Committee D 41 Victoria Parade Fitzroy, Melbourne, VIC 3065 Australia
Bowen, David G. Koorey, David J. McCaughan, Geoffrey W. Prakoso, Emilia Shackel, Nicholas Adam
31
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Sulkowski, Mark (35827)
Johns Hopkins University Medical Institutions Falls Concourse, Suite 412 10751 Falls Road Lutherville, MD 21093 United States
Local: Johns Hopkins University School of Medicine IRB, Office of Human Subjects Research Reed Hall, Suite B-130 1620 McElderry Street Baltimore, MD 21205-1911 United States
Brinkley, Sherilyn Durand, Christine Keller, Sara McArthur, Julie Melia, Michael
Tam, Edward (42420)
LAIR Centre Suite 305 750 West Broadway Vancouver, BC V5Z 1H2 Canada
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Viljoen, Mark
Tato Marinho, Rui (46971)
Hospital de Santa Maria Servico de Gastrenterologia e Hepatologia Centro Hospitalar de Lisboa Norte, EPE Avenida Prof. Egas Moniz Lisbon, 1649-035 Portugal
Central: CEIC – Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Ferreira, Paula Noronha Ferreira, Carlos Vieira, Catarina
32
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Urbanek, Petr (42788)
KlinMed s.r.o. Jugoslavska 16 Prague 2, 120 00 Czech Republic
Local: Fakultni Nemocnice Brno Local Ethics Committee Jihlavska 20 Brno, 625 00 Czech Republic
Marecek, Zdenek
van Hoek, Bart (45212)
Leiden University Medical Center C4-P Albinusdreef 2 Leiden, 2333 ZA Netherlands
Central: Academisch Medisch Centrum Medisch Ethische Commissie Meibergdreef 9 Amsterdam, 1105 AZ Netherlands
Coenraad, Minneke Joycellene Doves-Siegersma, Nynke Christine Inderson, Akin van Weyenberg, Stijn J.B.
Varunok, Peter (42371)
Premier Medical Group of the Hudson Valley, PC Suite 304 243 North Road Poughkeepsie, NY 12601 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Ashraf, Khurram I. Buffa, Salvatore M. Cahill, Alyson Dean, Robert S. Elmi, Farshad Hida, Sven Khurana, Sunil K. Muslim, Arif Nguyen, Thanh-Ho Sabatino, Meggin
33
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Wang, Chia (49531) (Replaced Kowdley, Kris [38934])
Virginia Mason Medical Center 1100 Ninth Avenue Seattle, WA 98101 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Ackermann, Sarah Cardona Gonzalez, Lupita Gelinas, Katharyn Kanwar, Pushpjeet Mooney, Jody C. Pierce, Tracey Shah, Nihar Shaw, Cheryl Siddique, Asma
Wedemeyer, Hans (40785)
Medizinische Hochschule Hannover Abteilung fuer Gastroenterologie, Hepatologie, Endokrinologie Carl-Neuberg-Strasse 1 Hannover, 30625 Germany
Local: Medizinische Hochschule Hannover Ethik-Kommission OE 9515 Carl-Neuberg-Strasse 1 Hanover, 30625 Germany
Cornberg, Markus Deterding, Katja Hoener zu Siederdissen, Christoph Maasoumy, Benjamin Manns, Michael Peter Port, Kerstin
Central: Ethik-Kommission des Fachbereichs Medizin der Johann Wolfgang Goethe-Universitaet Haus 1 Theodor-Stern-Kai 7 Frankfurt, 60590 Germany
34
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Weltman, Martin (39506)
Nepean Hospital Kingswood Department of Gastroenterology and Hepatology Derby St Kingswood, 2747 Australia
Local: St. Vincents Hospital Melbourne Human Research Ethics Committee D 41 Victoria Parade Fitzroy, Melbourne, VIC 3065 Australia
Hunt, James Stuart Wu, Yang Clare
Zarski, Jean-Pierre (45371)
CHU de Grenoble – Hopital Albert Michallon Clinique Universitaire d'HepatoGastroenterologie BP 217 Boulevard de la Chantourne Grenoble Cedex 9, 38043 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Antonino, Anca-Teodora Hilleret, Marie-Noelle Leroy, Vincent Tatu, Aurora
35
ABT-450/r/ABT-267, ABT-333 M13-098 Clinical Study Report – Final R&D/14/1304
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Zekry, Amany (38897) (Site did not enroll)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
St. George Hospital Department of Gastroenterology and Hepatology Gray Street Kogarah, NSW 2217 Australia
Local: St. Vincents Hospital Melbourne Human Research Ethics Committee D 41 Victoria Parade Fitzroy, Melbourne, VIC 3065 Australia
Farah, Beshoy Freiman, John Saul Pavendranathan, Gokulan
Central: St. Vincents Hospital Melbourne Human Research Ethics Committee D 41 Victoria Parade Fitzroy, Melbourne, VIC 3065 Australia
36
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Zeuzem, Stefan (40784)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Klinikum der Johann Wolfgang Goethe Universitaet Innere Medizin I Theodor-Stern-Kai 7 Frankfurt, 60590 Germany
Local: Klinikum der Johann Wolfgang Goethe Universitaet Ethik-Kommission des Fachbereichs Medizin Haus 1 Theodor-Stern-Kai 7 Frankfurt, 60590 Germany
Buslau, Anna Fitting, Daniel Gerber, Ludmila Kofler, Stefan Reichardt, Adriane Sprinzl, Kathrin Andrea Tal, Andrea Welzel, Tania
Central: Ethik-Kommission des Fachbereichs Medizin der Johann Wolfgang Goethe-Universitaet Haus 1 Theodor-Stern-Kai 7 Frankfurt, 60590 Germany Zogg, Donald Louis (81470) (Replaced Smith, Coleman [38847]) *Investigator is listed as "Zogg, -" in the clinical database.
Minnesota Gastroenterology, P.A Suite 120 2200 University Avenue West St. Paul, MN 55114 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Boldt, Mark Feldshon, S. David Heller, Leon (Chip) Storrs, Gina
37
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Zoulim, Fabien (44320)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hopital de la Croix Rousse Service d'Hepato-Gastro-Enterologie 103 Grande Rue de la Croix Rousse Lyon, 69004 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Bailly, Francois Hartig-Lavie, Kerstin Maynard-Muet, Marianne Trepo, Christian
38
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16.1__4
Investigators and Other Important Participants in the Study
16.1__4.1
List and Description of Investigators
1
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Agarwal, Kaushik (Kosh) (44408)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
University College London Hospitals NHS Foundation Trust Institute of Liver Studies Cheyne Wing, 3rd floor Denmark Hill London, SE5 9RS United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Al-Chalabi, Thawab Audimoolam, Vinod Barnabas, Ashley Carey, Ivana Verma, Suman
2
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Aguilar, Humberto (42730)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Louisiana Research Center, LLC Suite 318 1453 East Bert Kouns Shreveport, LA 71105 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Barber Stephens, Brandi Carroll, Beverly Chambers, Winde Davis, Jeremy Payne Dies, David Frank Giddings, Stacy Hatfield, Deborah Hebert, Heather Andrina Hobley, James C. Johnson, Lawrence Webster Miller, Seth Wayne Mohan, Sathya Narayana Raj Jagan Paskey, Stacy Philips, David Miller Poch, Arthur Lewis Provenza, John Mark Rimmer, Jr., Douglas Edward Robinson, Thomas Russell Salter, Robert Matthew White, John Michael
3
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Andreone, Pietro (45530)
Policlinico S. Orsola Malpighi Dipartimento di Medicina Clinica DAI di Malattie dell'Apparato Digerente e Medicina Interna Padiglione 11, Via Massarent, 9 Bologna, 40138 Italy
Local: Policlinico S. Orsola Malpighi Comitato Etico Indipendente Via Albertoni, 15 Bologna, 40138 Italy
Cursaro, Carmela Scuteri, Alessandra Vukotic, Ranka
Bacon, Bruce (38646)
St. Louis Univ School of Medicine Gastro and Hepatology Clinical Research Unit 2nd floor 3545 Lafayette Avenue St. Louis, MO 63104 United States
Local: St. Louis Univ School of Medicine Institutional Review Board Caroline Building C110 3556 Caroline Street St. Louis, MO 63104 United States
Befeler, Alex S. Campbell, Shirley Di Bisceglie, Adrian M. Shelley, Nancy L. Tetri, Brent A. Wilkins, Rebecca F. Wriston, Kristina L.
Bain, Vince (48838)
University of Alberta Zeidler Ledcor Centre Department of Medicine Division of Gastroenterology 130 University Campus Edmonton, AB T6G 2X8 Canada
Local: University of Alberta Health Research Ethics Board 308 Campus Tower 8625 - 112 Street Edmonton, AB T6G 1K8 Canada
Mason, Andrew Montano-Loza, Aldo Javier Tandon, Puneeta
4
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Baumgarten, Axel (34085)
mib Dienstleistung GmbH Seestrasse 13 Berlin, 13353 Germany
Local: Landesamt fuer Gesundheit und Soziales Ethik-Kommission des Landes Berlin Fehrbelliner Platz 1 Berlin, 10707 Germany Central: EK der Medizinischen Hochschule Hannover OE 9515 Carl-Neuberg-Strasse 1 Hannover, 30625 Germany
Ingiliz, Patrick Krznaric, Ivanka Weinberg, Gorden
Bennett, Michael (31542)
Medical Associates Research Group Suite 200 8008 Frost Street San Diego, CA 92123 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Flores, Sergio R. Khoshini, Reza Kim, Hyun S. Politoske, Douglas A. Pressman, Jeffrey H. Snyder, Richard J. Tuohy, Dianne
5
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Berenguer, Marina (45224)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hospital Universitario y Politenico La Fe Servicio de Hepatologia Torre F Planta 5 Calle Bulevar Sur s/n Valencia, 46026 Spain
Local: Hospital Universitario y Politenico La Fe CEIC Escuela de Enfermeria, 6a Planta - Hab.613 Av. Campanar, 21 Valencia, 46009 Spain Central: Hospital Universitario y Politenico La Fe CEIC Escuela de Enfermeria, 6a Planta - Hab.613 Av. Campanar, 21 Valencia, 46009 Spain
Aguilera Sancho-Tello, Victoria Benlloch, Salvador Garcia-Eliz, Maria Hontangas, Vanessa Prieto Castillo, Martin Vinaixa Aunes, Carmen
6
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Berg, Thomas (43114) *Investigator number is 4311402 in the clinical database.
Bernstein, David (38853)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Zentrum fuer Innere Medizin der Universitaet Leipzig Klinik und Poliklinik für Gastroenterologie & Rheumatologie Liebigstr. 20 Leipzig, 04103 Germany
Local: Universitaetsklinikum Leipzig Ethik-Kommission der Medizinischen Fakultat der Universitat Leipzig Haus: Karl-Sudhoff-Institut Kaethe-Kollwitz-Strasse 82 Leipzig, 04109 Germany Central: Medizinische Hochschule Hannover Ethik-Komission - OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany
Boehlig, Albrecht Herber, Adam Koukoulioti, Eleni Wiegand, Johannes Ziagaki, Athanasia
North Shore-Long Island Jewish Health System 4 Levit 300 Community Drive Manhasset, NY 11030 United States
Local: Biomedical Research Alliance of New York, LLC IRB Suite 210 1981 Marcus Avenue Lake Success, NY 11042 United States
DeVito, Bethany S. Duddempudi, Anupama T. Khodadadian, Edna Palmer, Radica Tiev, Maly
7
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Biermer, Michael (47597) (Replaced by Heyne, Renate [50924])
Leber- und Studienzentrum am Checkpoint Charlottenstrasse 81 Berlin, 10969 Germany
Central: Medizinische Hochschule Hannover Ethik-Komission - OE 9515 Carl-Neuberg-Strasse 1 Hannover, 30625 Germany Local: Landesamt fuer Gesundheit und Soziales Ethik-Kommission des Landes Berlin Fehrbelliner Platz 1 Berlin, 10707 Germany
Berg, Thomas Heyne, Renate Moeller, Bernd Moeller, Hjoerdis
Bourgeois, Stefan (47437)
ZNA Stuivenberg SGS CPU Lange Beeldekensstraat 267 Antwerp, 2060 Belgium
Central: Cliniques Universitaires Saint Luc Commission d'Ethique Biomedicale Hospitalo-Facultaire, Tour Harvey Niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Anthone, Nancy Gheyle, Lien Haazen, Wouter Mesens, Sofie Petkova, Magdalena Ramael, Steven Vets, Eva
8
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Bourliere, Marc (44317)
Hopital Saint Joseph Department of Hepato Gastroenterology 26 Boulevard de Louvain Marseilles, 13285 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Ansaldi, Christelle Ben Ali, Souad
Box, Terry (20229)
Clinical Research Centers of America, LLC Suite B 5450 South Green Street Murray, UT 84123 United States
Central: Quorum Review IRB PO Box 84572 Seattle, WA 98124 United States
Cobb, Deborah Deans, Amy Little, Susan Munk, Heather Stevens, Kerin Strong, Sharon Thomason, I. Raymond Waddoups, Lindsey
Boyer, Thomas (42358)
University of Arizona Medical Center Liver Research Institute Rm 6309 1501 N. Campbell Avenue Tucson, AZ 85724-5136 United States
Local: Western Institutional Review Board (WIRB) Suite 120 1019 39th Ave SE Puyallup, WA 98374-2115 United States
Habib, Shahid Peters, Carol L
9
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Brown, Ashley (47009)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
St. Marys Hospital Liver and Anti-Viral Unit 10th Floor, Queen Elizabeth The Queen Mother Building (QEQM) Praed Street London, W2 1NY United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Main, Janice Nieddu, Paolo Saleh, Ghada Selvapatt, Nowlan
10
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Castro Iglesias, Maria (47326)
Complejo Hospitalario Universitario de A Coruna Medicina Interna Calle as Xubias, 85 A Coruna, 15006 Spain
Local: Comite Etico de Investigacion Clinica de Galicia Division de Farmacia y Productos Sanitarios Edificio Administrative San Lazaro, s/n La Coruna Santiago de Compostela, 15703 Spain Central: Hospital Universitario y Politenico La Fe CEIC Escuela de Enfermeria, 6a Planta - Hab.613 Av. Campanar, 21 Valencia, 46009 Spain
Lopez, Soledad Mena, Alvaro Pedreira, Jose Domingo Pernas, Berta Vazquez, Pilar
Cebollero-Santamaria, Francisco (45461)
Gastroenterologia Avanzada del Caribe CPR Building 104 #55 De Diego Street Mayaguez, 00681 Puerto Rico
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Ramirez-Ronda, Ramon A.
11
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Craxi, Antonio (39006)
Azienda Ospedaliera Universitaria Policlinico P. Giaccone Dipartimento di Gastroenterologia ed Epatologia Piazza delle Cliniche, 2 Palermo, 90127 Italy
Local: Azienda Ospedaliera Universitaria Policlinico P. Giaccone Comitato Etico Via del Vespro 129 Palermo, 90127 Italy
Almasio, Piero Luigi Bavetta, Maria Grazia Calvaruso, Vincenza Petta, Salvatore
Davis, Mitchell (40605)
South Florida Center of Gastroenterology, P.A. Suite # 205 1447 Medical Park Boulevard Wellington, FL 33414 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Sacks, Steven R Smith, Matthew J. Wahl, Joan K.
Dillon, John (32918)
Ninewells Hospital Biomedical Research Institute, Medical School Gastro Lab Level 5 Dundee, DD1 9SY United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Evans, Morgan Heron, Tim Miller, Michael
12
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Dusheiko, Geoffrey (42783)
The Royal Free Hospital Division of Medicine Centre for Hepatology Pond Street London, NW3 2QG United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Burney, Tabinda Rosenberg, William Trembling, Paul
Enayati, Pedram (40076)
California Liver Institute Suite 1020 E 8631 W. 3rd Street Los Angeles, CA 90048 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Mathew, Lucy
Everson, Gregory (37869)
University of Colorado Denver and Hospital AOP 7th floor 1635 Aurora Court Aurora, CO 80045 United States
Local: Western Institutional Review Board (WIRB) 3535 Seventh Avenue Southwest Olympia, WA 98502-5010 United States
Bambha, Kiran Bhatt, Asmeen Biggins, Scott Burton, James R. Forman, Lisa Henrichs, Kelly Pratt, Lindsay Rosen, Hugo Tise, Sarah 13
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Fernandez Rodriguez, Conrado (45484)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hospital Universitario Fundacion Alcorcon Servicio de Aparato Digestivo Secretaria de Especialidades Medicas, planta A0 C/Budapest 1 Alcorcon (Madrid), 28922 Spain
Central: Hospital Universitario y Politenico La Fe CEIC Escuela de Enfermeria 6a Planta Hab. 613 Avda Companar, 21 Valencia, 46009 Spain Local: Hospital Universitario Fundacion Alcorcon CEIC Area 8 Secretaria del Comite Etico de Investigacion Clinica, Planta Sotano Calle Budapest 1 Alcorcon (Madrid), 28922 Spain
Alonso, Sonia Gutierrez, Maria Luisa
14
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Forns, Xavier (40722)
Hospital Clinic de Barcelona Consultas externas de Hepatologia Hospital Casa Maternidad, Edificio Hellos III, 1a planta C/ Sabino de Arana, s/n Barcelona, 08028 Spain
Central: Hospital Universitario y Politenico La Fe CEIC Escuela de Enfermeria 6a Planta Hab. 613 Avda Companar, 21 Valencia, 46009 Spain Local: Hospital Univ Clinic i Provincial Comite Etico de Investigacion Clinica, Servicio de Farmacia Escalera 8 Sotano C/ Villaroel, 170 Barcelona, 08036 Spain
Lens, Sabela Londono, Maria Carlota Marino, Zoe
Foster, Graham (43110)
The Royal London Hospital Grahame Hayton Unit, (GHU) Ambrose King Centre Whitechapel Road London, E1 1BB United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Cunningham, Morven De Silva, Sampath Dearden, Janet Gill, Upgar Hansi, Navjyot Lahiri, Rajiv
15
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Fouchard-Hubert, Isabelle (47939)
CHU d'Angers Service d'Hepato-Gastroenterologie 4 Rue Larrey Angers Cedex 9, 49933 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Boursier, Jerome Cales, Paul Lunel-Fabiani, Francoise Oberti, Frederic
Freilich, Bradley (22854)
Kansas City Research Institute Suite 430 6675 Holmes Road Kansas City, MO 64131 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Kissinger, Janay A.
Fried, Michael (37834)
University of North Carolina at Chapel Hill School of Medicine, Division of Gastroenterology and Hepatology 8015 Burnett Womack Building - CB#7584 99 Manning Drive Chapel Hill, NC 27599-7584 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Barritt IV, Alfred Sidney Blanchard, Renee T. Cardona, Danielle Elizabeth Darling, Jama Margaret Elliott, Scott Mathew Hayashi, Paul Hideyo Jones, Tamara S. Metheny, Vikki G. Zacks, Steven Lawrence
16
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Goff, John (4253)
Rocky Mountain Gastroenterology Associates 7000 West Colfax Avenue Lakewood, CO 80215 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Hightower, Lynn M. Jain, Rajesh Mackenzie, Scott H. Reveille, Robert Matthew
Good, Gary (42808)
Upper Delaware Valley Infectious Diseases Suite 1 427 Broadway Monticello, NY 12701 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Singer, Ethan A.
Gordon, Stuart (38627)
Henry Ford Health System K-7 2799 West Grand Blvd Detroit, MI 48202 United States
Local: Henry Ford Hospital Henry Ford Health System IRB CFP-046 2799 West Grand Boulevard Detroit, MI 48202 United States
Hanschu, Inge Maria Moeller, Matthew Schairer, Jason Nicholas Tang, Jeffrey Christian Yudovich, Allen
17
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hanson, John (19986) (Site did not enroll)
Charlotte Gastroenterology and Hepatology, PLLC Suite 208 2015 Randolph Road Charlotte, NC 28207 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Lawson, Aimee M. Mohanty, Sanjib P. Prendiville, Simon S. Roddey Jr., John Gardiner R. Scholz, David G. Stone, Eric E. Wilson, Jason A.
Hassanein, Tarek (16471)
Southern California Research Center Suite 101 131 Orange Avenue Coronado, CA 92118 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Biando, Karel Hefner, Anna Marie Mendoza, Adriana Meza, Lauren Elizabeth Reshamwala, Preeti A. Vargas, Chanel
18
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Heyne, Renate (50924) (Replaced Biermer, Michael [47597])
Leber- und Studienzentrum am Checkpoint Charlottenstrasse 81 Berlin, 10969 Germany
Central: Medizinische Hochschule Hannover Ethik-Komission - OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany Local: Landesamt fuer Gesundheit und Soziales Ethik-Kommission des Landes Berlin Fehrbelliner Platz 1 Berlin, 10707 Germany
Berg, Thomas Fueloep, Balazs Moeller, Bernd Moeller, Hjoerdis
Hezode, Christophe (44318)
CHU Henri Mondor Service d'Hepato-Gastoenterologie 51 Avenue du Marechal de Lattre de Tassigny Creteil, 94010 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Borghi-Scoazec, Giovanna Mallat, Ariane Varaut, Anne
19
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Horsmans, Yves (45227)
Cliniques Universitaires Saint Luc Avenue Hippocrate 10 Brussels, 1200 Belgium
Central: Cliniques Universitaires Saint Luc Commission d'Ethique Biomedicale Hospitalo-Facultaire Tour Harvey Niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Starkel, Peter
Jacobson, Ira (37740)
Weill Medical College of Cornell University 4th Floor 1305 York Avenue New York, NY 10021 United States
Local: Weill Medical College of Cornell University Institutional Review Board 1st floor 407 East 61st Street New York, NY 10065 United States
Carasso, Monique Cervini, Christine Kumar, Sonal Marks, Kristen Olson, Mary Opong, Adomah
20
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Kowdley, Kris (38934) (Replaced by Wang, Chia [49531])
Virginia Mason Medical Center MS: C3-GAS 1101 9th Avenue Seattle, WA 98101 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Cardona-Gonzalez, Lupita Gelinas, Katharyn Kanwar, Pushpjeet Lee, Maximilian Mooney, Jody C. Pierce, Tracey Shah, Nihar Shaw, Cheryl Siddique, Asma Siekas, Lacey Wagenaar, Rebecca M. Rankin Wang, Chia C.
Kwo, Paul (37868)
Indiana University IUSCC Room C2102 550 N. University Boulevard Indianapolis, IN 46202-5271 United States
Local: Western Institutional Review Board (WIRB) 3535 Seventh Avenue Southwest Olympia, WA 98508 United States
Lacerda, Marco Yoo, Hwan
21
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Larrey, Dominique (44367)
Hopital Saint Eloi Service d'Hepato-Gastroenterologie et Transplantation CHRU Montpellier 80 Avenue Fliche Montpellier - Cedex 5, 34295 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Faure, Stephanie Pageaux, Georges-Philipp Ripault, Marie-Pierre
Lawitz, Eric (37388) (Replaced by Poordad, Fred [37739])
Texas Liver Institute, American Research Corporation 607 Camden Street San Antonio, TX 78215 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Castillo, Maria Theresa Coste, Angela M. France, Michael R. Freeman-Trudo, Joni Leann Membreno, Fernando E. Poordad, Fred F. Trevino-Garcia, Veronica
Lee, Samuel (48171)
University of Calgary HSC G130 Teaching, Research and Wellness Building 3280 Hospital Drive Northwest Calgary, AB T2N 4Z6 Canada
Local: University of Calgary Conjoint Health Research Ethics Board (CHREB), Office of Medical Bioethics Research Services Office, Energy Resource Research Building Suite N 140, 3512 33rd Street NW Calgary, AB T2L 2A6 Canada
Burak, Kelly Coffin, Carla Eksteen, Bertus Jayakumar, Saumya Myers, Robert Paul Swain, Mark
22
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Levin, James (32294)
Dean Clinic 1313 Fish Hatchery Road Madison, WI 53715 United States
Local: Dean Foundation for Health, Research and Education Institutional Review Board Suite 300 2711 Allen Boulevard Middleton, WI 53562 United States
Jean-Louis, Garry Nasrallah, Ammar Fathi
Lucey, Michael (38625)
University of Wisconsin Hospital and Clinics 4268 MFCB 1685 Highland Avenue Madison, WI 53705-2281 United States
Local: Western Institutional Review Board (WIRB) 1019 39th Avenue SE Puyallup, WA 98374 United States
Agarwal, Parul Cervantes, Lisa L. Evans, Virginia Glasser, Annette Kennedy, G Patrice Musat, Alexandru Rice, John Said, Adnan
Martin, Paul (38652)
University of Miami Schiff Center for Liver Diseases Suite 1101 1500 NW 12th Avenue Miami, FL 33136 United States
Local: University of Miami Human Subjects Research Office (HSRO) Suite 1002 1500 NW 12th Avenue Miami, FL 33136 United States
Bhamidimarri, Kalyan Ram Levy, Cynthia O'Brien, Christopher
23
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Mills, Peter (47321)
Gartnavel General Hospital Western Infirmary and Gartnavel General Hospital 1053 Great Western Road Glasgow, G12 0YN United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Bell, David Fox, Raymond Priest, Matthew Thomson, Emma
Muir, Andrew (46464)
Duke University Medical Center Orange Zone Suite 03107, Room 03137-B, Basement 200 Trent Drive, Duke South Durham, NC 27710 United States
Local: Duke University Medical Center Health System Institutional Review Board Hock Plaza, Suite 405 2424 Erwin Road Durham, NC 27705 United States
Goacher, Elizabeth King Jezsik, Janet A. Naggie, Susanna Patel, Keyur Ross, Loranda
Mulkay, Jean-Pierre (45465)
CHU St. Pierre Rue Haute 322 Brussels, 1000 Belgium
Central: Cliniques Universitaires Saint Luc Commission d'Ethique Biomedicale Hospitalo-Facultaire, Tour Harvey Niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Serste, Thomas Van Gossum, Marc
24
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Mutimer, David (47008)
University Hospitals Birmingham NHS Queen Elizabeth Hospital 3rd. Floor, Nuffield House Mindelsohn Way, Edgbaston Birmingham, B15 2TH United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Elsharkawy, Ahmed Holt, Andrew Oo Htun, Ye Rowe, Ian
Nash, Kathryn (43109)
Southampton General Hospital NHS Foundation Trust Termona Road, Hampshire Southampton, SO16 6YD United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Domanski, Aleksander Hydes, Theresa Nagaraj, Jagadish Wright, Mark
25
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Nelson, David (38624)
University of Florida Hepatology Research at CTRB 2004 Mowry Road Gainesville, FL 32610 United States
Local: Western Institutional Review Board (WIRB) 1019 39th Ave. SE Puyallup, WA 98374 United States
Bauer, Angela Marie Cabrera, Roniel Clark, Virginia Catherine Firpi-Morell, Roberto J. Gunnett, Amy Michelle Horne, Patrick Michael Martin, Angela Bauer Mills, Rennie Marie Morelli, Giuseppe (Joesph) Peter, Joy Anne
Nevens, Frederik (45199)
Universitair Ziekenhuis Leuven Herestraat 49 Leuven, 3000 Belgium
Central: Cliniques Universitaires Saint Luc Commission d'Ethique Biomedicale Hospitalo-Facultaire, Tour Harvey Niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Cassiman, David Laleman, Wim Van der Merwe, Schalk
Pockros, Paul (36927)
Scripps Clinic 10666 N. Torrey Pines Road La Jolla, CA 92037 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Chang, Jill Y. Frenette, Catherine T. Goicoechea, Miguel A. Scherschel, Andrea C.
26
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Pol, Stanislas (44319)
Groupe Hospitalier Cochin Unite Fonctionnelle Hepatologie Medicale Pole Medico-Chirugical d'Hepo-Gastroenterologie 27 Rue du Faubourg Sant Jaques Paris Cedex 14, 75679 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Corouge, Marion Fontaine, Helene Mallet, Vincent Sogni, Philippe Trabut, Jean-Baptiste Tripon, Simona Vallet-Pichard, Anais
Poliquin, Marc (40549)
Clinique Medicale L'Actuel Suite 1130 1001 Boulevard Maisonneuve East Montreal, QC H2L 4P9 Canada
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Huchet, Emmanuelle Longpre, Daniele Thomas, Rejean Trottier, Benoit Vezina, Sylvie
27
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Poordad, Fred (37739) (Replaced Lawitz, Eric [37388])
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Texas Liver Institute, American Research Corporation 607 Camden Street San Antonio, TX 78215 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Architect, Karen L. Castillo, Maria Theresa Coste, Angela M. France, Michael R. Freeman-Trudo, Joni Leann Gutierrez, Julio Anacleto Lawitz, Eric J. Membreno, Fernando E. Salcido, Rossalynn Marie Trevino-Garcia, Veronica Wentworth, Corinne Lee
GIRI Gastrointestinal Research Institute Suite 700 1190 Hornby Street Vancouver, BC V6Z 2K5 Canada
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Amar, Jack N. Bressler, Brian L. Enns, Robert A. Halparin, Lawrence Ko, Hin Hin Lam, Eric Chon-San Telford, Jennifer Jan Whittaker, J. Scott
*Investigator number is 3773902 in the clinical database.
Ramji, Alnoor (47486)
28
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Reau, Nancy (48135)
University of Chicago Medical Center MC-7120 5841 S. Maryland Avenue Chicago, IL 60637 United States
Local: University of Chicago IRB McGiffert House, 2nd Floor 5751 South Woodlawn Avenue Chicago, IL 60637 United States
Aronsohn, Andrew Arrieta, Rosario L. Jensen, Donald M. Komar-Samardzija, Melanie Newsome, Maria A. Reddy, K. Gautham Silver, Audrey I. Te, Helen S. Williams, Monique L.
Reindollar, Robert (41723)
Carolinas Center For Liver Disease Suite 100 633 Brookdale Statesville, NC 28677 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Ellis, Justin D. Powell, Jesse G.
Rodriguez-Perez, Federico (45122)
Klinical Investigations Group, LLC Office 303 1420 Americo Salas St. Santurce, 00909 Puerto Rico
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Bigio, Johanna
29
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Rosado-Carrion, Barbara (47091)
Gastro-Hepatology & Geriatric Center Galeria del Sur Building, Suite 200 1046 Ave. Hostos Ponce, 00716 Puerto Rico
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Perez-Roman, Heidi Marie Torres-Lozada, Francisco J.
Ryan, Michael (31549)
Digestive and Liver Disease Specialists Suite 114 885 Kempsville Road Norfolk, VA 23502 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Ayers, Paula R. Biddle, Wendy Brooks, Whitney D. Hornbuckle, Kelvin Johnson, David A. Smith, John H. Thiwan, Syed Ismael M. Willis, Jeff R. Wootton III, F. Taylor
30
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Ryder, Stephen (42765)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Universiity Hospital Queen's Medical Centre Nottingham Digestive Diseases Centre and Biomedical Research Unit Nottingham University Hospitals NHS Trust Derby Road, Queens Medical Centre Campus Nottingham, NG7 2UH United Kingdom
Local: NRES Committee London - City and East South West REC Centre, Level 3, Block B Whitefriars, Lewins Mead Bristol, BS1 2NT United Kingdom
James, Martin Thomas, James
31
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Schuchmann, Marcus (38887) Replaced by Sprinzl, Martin [49779])
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz I. Medizinische Klinik und Poliklinik Langenbeckstrasse 1 Mainz, 55131 Germany
Central: Medizinische Hochschule Hannover Ethik-Komission - OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany Local: Ethik-Kommission Landesaerztekammer Rheinland-Pfalz Deutschhausplatz 3 Mainz, 55116 Germany
Grambihler, Annette Kittner, Jens Martin Schattenberg, Joern Markus Sprinzl, Martin Franz Thieringer, Florian Rolf Zimmermann, Tim
Sherman, Kenneth (40529)
University of Cincinnati, College of Medicine UC Physicians Company, Division of Digestive Diseases Mail Location #0595 231 Albert Sabin Way Cincinnati, OH 45267-0595 United States
Local: Western Institutional Review Board (WIRB) South Hill Business & Technology Center 1019 39th Ave., S.E. Olympia, WA 98502-5010 United States
Bari, Khurram Daria, Diane Gacheru, Tarsicio G Hussain, Syed Jennings, Carrie L. Sibert, Susan R. Zucker, Stephen D.
32
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Sherman, Morris (40603)
Toronto General Hospital - University Health Network NCSB11C 1252 585 University Avenue Toronto, ON M5G 2N2 Canada
Local: University Health Network - Toronto Western Hospital Research Ethics Board 700 University Ave Toronto, ON M5G 1Z5 Canada
Fung, Scott Yogeswaran, Kumar
Shiffman, Mitchell (40537)
Liver Institute of Virginia Suite 313 12720 McManus Boulevard Newport News, VA 23602 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Alexander, Philip C. Coleman, Rochelle Hamlin, Tashara James, Amy Long, April Tipps, Suzette Townsend, Denisha Vollum, Susan Williams, Shanay
33
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Sprinzl, Martin (49779) (Replaced Schuchmann, Marcus [38887])
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz I. Medizinische Klinik und Poliklinik Langenbeckstrasse 1 Mainz, 55131 Germany
Central: Medizinische Hochschule Hannover Ethik-Komission - OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany Local: Ethik-Kommission Landesaerztekammer Rheinland-Pfalz Deutschhausplatz 3 Mainz, 55116 Germany
Grambihler, Annette Schattenberg, Joern Markus Zimmermann, Tim
Sullivan, James (12538)
Parkway Medical Center 1160 Huffman Road Birmingham, AL 35215 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
King, Duane W.
34
ABT-450/r/ABT-267, ABT-333 M13-099 Clinical Study Report – Final R&D/14/1300
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Tran, Albert (47112)
CHU de Nice Pole de reference Hepatite C, Niveau -2 Hopital de l'Archet 2 151 Route de Saint Antoine de Ginestiere Nice Cedex 3, 06202 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Foti, Pauline Truchi, Regine
Trautwein, Christian (48309)
Universitaetsklinikum Aachen Pauwelsstr. 30 Aachen, 52074 Germany
Local: Universitaetsklinikum Aachen Ethik-Kommission and der Medizinischen Fakultaet der Rheinisch-Westfaelischen Technischen Hochschule Aachen Pauwelsstr. 30 Aachen, 52074 Germany Central: Medizinische Hochschule Hannover Ethik-Komission - OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany
Lutz, Holger Strnad, Pavel Tacke, Frank Temizel, Ilknur Voigt, Sebastian
35
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Ustianowski, Andrew (47010)
North Manchester General Hospital Infectious Diseases Research Department 2nd Floor J Block Delaunays Road, Crumpsall Manchester, M8 5RB United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Baxter, Joanne Uriel, Alison Jane Van Helsema, Clare
Van Vlierberghe, Hans (38878)
University Ziekenhuis Ghent, UZ Ghent De Pintelaan 185 Ghent, 9000 Belgium
Central: Cliniques Universitaires Saint Luc Commission d'Ethique Biomedicale Hospitalo-Facultaire, Tour Harvey Niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Geerts, Anja Verhelst, Xavier
Vargas, Hugo (37741)
Mayo Clinic Arizona 5777 E. Mayo Boulevard Phoenix, AZ 85054 United States
Local: Mayo Clinic Institutional Review Board 200 First Street Southwest Rochester, MN 55905 United States
Byrne, Thomas J. Carey, Elizabeth J. Chervenak, Amy E. Douglas, David D. Mahmoud Aqel, Bashar Ahmed
36
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Wang, Chia (49531) (Replaced Kowdley, Kris [38934])
Virginia Mason Medical Center MS: C3-GAS 1101 9th Avenue Seattle, WA 98101 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Ackermann, Sarah Cardona-Gonzalez, Lupita Gelinas, Katharyn Mooney, Jody C. Shaw, Cheryl Siddique, Asma
Weber, Jr., Fredrick (42372)
Gastroenterology Research Consultants of Greater Cincinnati Trihealth, Inc Suite 200 & 300 10600 Montgomery Road Cincinnati, OH 45242 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Bawtenheimer, Vivian Ann Bell, Grace Ellen Firsich, Nancy M. Grandhi, Nav Kumar Hoffman, Laura Lee Peck, Allan Lawrence
37
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Wedemeyer, Hans (40785)
Medizinische Hochschule Hannover Abteilung fuer Gastroenterologie, Hepatologie, Endokrinologie Carl-Neuberg-Strasse 1 Hannover, 30625 Germany
Local: Medizinische Hochschule Hannover Ethik-Komission - OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany Central: Medizinische Hochschule Hannover Ethik-Komission - OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany
Cornberg, Markus Deterding, Katja Hoener zu Siederdissen, Christoph Maasoumy, Benjamin Manns, Michael Peter Port, Kerstin
Yoshida, Eric (47487)
Gordon and Leslie Diamond Care Centre 5153 - 2775 Laurel Street Vancouver, BC V5Z 1M9 Canada
Local: UBC Clinical Research Ethics Office Room 210, Research Pavillion 828 West 10th Avenue Vancouver, BC V5Z 1L8 Canada
Erb, Siegfried Kwan, Peter Steinbrecher, Urs
Younes, Ziad (22887)
Gastro One Suite A 1310 Wolf Park Drive Germantown, TN 38138 United States
Local: Quorum Review IRB 1501 Fourth Ave. Seattle, WA 98101 United States
Elsakr, Raif W. Leal, Rolando J. Pop, Anca I. Wooten, Robert S.
38
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Zeuzem, Stefan (40784)
Klinikum der Johann Wolfgang Goethe Universitaet Innere Medizin I Theodor-Stern-Kai 7 Frankfurt, 60590 Germany
Local: Klinikum der Johann Wolfgang Goethe Universitaet Ethik-Kommission des Fachbereichs Medizin Haus 1 Theodor-Stern-Kai 7 Frankfurt, 60590 Germany Central: Medizinische Hochschule Hannover Ethik-Komission - OE 9515Carl-Neuberg-Strasse 1 Hannover, 30625 Germany
Buslau, Anna Fitting, Daniel Gerber, Ludmilla Kofler, Stefan Reichhardt, Adriane Sprinzl, Kathrin Andre Tal, Andrea Welzel, Tania
Zoulim, Fabien (44320)
Hopital de la Croix Rousse Service d'Hepato-Gastro-Enterologie 103 Grande Rue de la Croix Rousse Lyon, 69004 France
Central: CPP lle de France 8, Hopital Ambroise Pare Laboratoire d'Anatomopathologie 9 Avenue Charles de Gaulle Boulogne Billancourt, 92100 France
Bailly, Francois Hartig-Lavie, Kerstin Maynard-Muet, Marianne
39
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16.1__4
Investigators and Other Important Participants in the Study
16.1__4.1
List and Description of Investigators
1
ABT-450/r/ABT-267, ABT-333 M13-389 Clinical Study Report – Final R&D/14/1301
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Aggarwal, Avanish (36888)
Internal Medicine Specialists 3885 Oakwater Circle Orlando, FL 32806 United States
Central: Chesapeake Research Review, Inc. Suite 110 7063 Columbia Gateway Drive Columbia, MD 21046-3403 United States
Bhaskar, Sudhir Kumar Jolly, Walter Mike
Andreone, Pietro (45530)
Policlinico S. Orsola Malpighi Dipartimento di Medicina Clinica DAI di Malattie dell'Apparato Digerente e Medicina Interna Padiglione 11, Via Massarent, 9 Bologna, 40138 Italy
Local: Policlinico S. Orsola Malpighi Comitato Etico Indipendente Via Albertoni, 15 Bologna, 40138 Italy
Cursaro, Carmela Gamal, Nesrine Scuteri, Alessandra
Arora, Sanjeev (40544)
University of New Mexico Dept. of Internal Medicine 5ACC/2211 Lomas Blvd, NE Albuquerque, NM 87131 United States
Local: University of New Mexico Human Reserach Protections Office BMSB B71 MSC 084560 1 University of New Mexico Albuquerque, NM 87131 United States
Morgan, Nancy Thornton, Karla
2
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Bernstein, David (38853)
North Shore-Long Island Jewish Health System 300 Community Drive Manhasset, NY 11030 United States
Local: Biomedical Research Alliance of New York, LLC IRB Suite 210 1983 Marcus Avenue Lake Success, NY 11042 United States
DeVito, Bethany S. Duddempudi, Anupama T. Khodadadian, Edna Tiev, Maly
Bhandari, Bal Raj (45219)
Delta Research Partners, LLC 616 South Washington Street Bastrop, LA 71220 United States
Central: Chesapeake Research Review, Inc. Suite 110 7063 Columbia Gateway Drive Columbia, MD 21046-3403 United States
Carpenter, Bridgett Kraft, Kacy McCullars, Melissa Petrus, Casey
Bjorkman, Per (45208) (Replaced by Hakangard, Camilla [47647])
Skanes University Hospital Malmo Infektionskliniken Mottagning Ruth Lundskogsgata 3 Malmo, SE-205 02 Sweden
Central: Regionala etikprovningsnamnden i Stockholm FE 289 Stockholm, 171 77 Sweden
Flamholc, Leo Hakangard, Camilla Jerkman, Anna Wallmark, Eva Wiksell, Peter
3
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Bowlus, Christopher (53094) (Replaced Rossaro, Lorenzo [40602])
University of California Davis GI/Hepatology CTU Suite 100 2000 Stockton Boulevard Sacramento, CA 95817 United States
Local: University of California Davis UC Davis- IRB Administration CTSC Building, Room 1429, Suite 1400 2921 Stockton Boulevard Sacramento, CA 95817 United States
Lester, Laura Medici, Valentina
Brunetto, Maurizia (47140)
Azienda Ospedaliera Universitaria Pisana Unita Operativa di Epatologia Via Paradisa, 2 Cisanello Pisa, 56126 Italy
Local: Azienda Ospedaliera Universitaria Pisana Comitato Etico di Area Vasta Nord Ovest Via Roma, 67 Pisa, 56126 Italy
Ciccorossi, Pietro Coco, Barbara Colombatto, Piero Romagnoli, Veronica
Calinas, Filipe (47040)
Hospital Santo Antonio dos Capuchos Servico de Gastroenterologia Centro Hospitalar de Lisboa Central, EPE Alameda Santo Antonio dos Capuchos Lisbon, 1169-050 Portugal
Central: CEIC – Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Silva, Mario Jorge
4
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Caporaso, Nicola (47142)
Azienda Ospedaliera Universita degli studi Federico II Unita Operativa di Gastroenterologia Via Pansini, 5 Naples, 80131 Italy
Local: Azienda Ospedaliera Universita degli studi Federico II Comitato Etico per le Attivita Biomediche Via Pansini, 5 Naples, 80131 Italy
Camera, Silvia Donnarumma, Laura Granata, Rocco Morisco, Filomena
Carney, David (49265) (Site did not enroll)
Trial Management Associates; LLC 5115 Oleander Drive Wilmington, NC 28403 United States
Central: Chesapeake Research Review, Inc. Suite 110 7063 Columbia Gateway Drive Columbia, MD 21046-3403 United States
Cook, Christine Gulish, Kristen King, William Walter Klein, Steven Douglas Nichols, Jean Ellen Pennington, Stacey Erin
Cerny, Andreas (45399)
Fondazione Epatocentro Ticino, SA Via Soldino, 5 Lugano, 6900 Switzerland
Local: Comitato Etico Cantonala c/Ufficio di Sanita Vio Orico 5 Bellinzona, 6501 Switzerland
Balmelli, Manuela Bihl, Florian Gurtner, Vanina Magenta, Lorenzo Moriggia, Alberto Robatto, Antonella Terziroli, Benedetta
5
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Colombo, Massimo (39008)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Divisione di Gastroenterologia Via Sforza, 35 Milan, 20122 Italy
Local: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Comitato di Etica Pad. Beretta -2 piano Via Sforza, 28 Milan, 20122 Italy
Aghemo, Alessio Michele D'Ambrosio, Roberta Grassi, Eleonora
de Knegt, Robert (48121) (Site did not enroll)
Erasmus Medisch Centrum s-Gravendijkwal 230 Rotterdam, 3015 CE Netherlands
Central: Academisch Medisch Centrum Medisch Ethische Commissie Meibergdreef 9 Amsterdam, 1105 AZ Netherlands
Koning, Ludi Maan, Raoel van der Meer, Adriaan Johannes Pieter
Delwaide, Jean (45217) (Site did not enroll)
CHU Sart Tilman Domaine Universitaire du Sart Tilman, B35 Liege, 4000 Belgium
Central: Comission d'Ethique Biomedicale Hospitalo-Facultaire de UCL Cliniques Universitaires Saint-Luc Tour Harvey niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Lamproye, Anne Verset, Gontran
6
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Dufour, Jean-Francois (45400)
Inselspital - Universitaetsspital Bern Universitaetsklinik fuer Viszerale Chirugie und Medizin Freiburgstrasse 10 Bern, 3010 Switzerland
Local: Kantonale Ethikkommission Bern (KEK) Postfach 56 Bern, 3010 Switzerland
De Gottardi, Andrea Semmo, Nasser Stirnimann, Guido
Ferenci, Peter (45268)
Medical University of Vienna Klinische Abteilung fuer Gastroenterologie und Hepatologie Univ. Klinik f. Innere Medizin III Waehringer Guertel 18-20 Vienna, 1090 Austria
Central: Ethikkommission der Medizinischen Universitaet Wien und des allgemeinen Krankenhauses der Stadt Wien-AKH Borschkegasse 8b/E06 Vienna, 1090 Austria
Beinhardt, Sandra Freissmuth, Clarissa Hofer, Harald Kozbial, Karin Munda, Petra Rutter, Karoline Scherzer, Thomas Matthias Staettermayer, Albert Friedrich Strassl, Robert Paul Trattner, Hannes
Fessel, W. Jeffrey (48778)
Kaiser Permanente Medical Center, Clinical Trials Unit Suite 219 4141 Geary Boulevard San Francisco, CA 94118 United States
Local: Kaiser Permanente Northen California IRB 16th Floor 1810 Harrison Street Oakland, CA 94612-3431 United States
Anderson, Brooke Casias, Cristina Dillon, Aileen Follansbee, Stephen Hare, Charles Bradley Mettinger, Miki
7
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Francque, Sven (38879)
Universitair Ziekenhuis Antwerpen Wilrijkstraat 10 Edegem, 2650 Belgium
Central: Comission d'Ethique Biomedicale Hospitalo-Facultaire de UCL Cliniques Universitaires Saint-Luc Tour Harvey niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Michielsen, Peter Steinhauser, Toon Van Den Bogaert, Erika
Gaeta, Giovanni (45531)
University of Naples Unita Epatiti Virali Acute e Coniche Via S. Pansini, 5 Naples, 80131 Italy
Local: University of Naples Comitato Etico Via S. Maria di Constantinopoli n. 104 Naples, 80138 Italy
Brancaccio, Giuseppina Marchese, Valentina
Galen, Edward (46903)
Northwest Gastroenterology Clinic, LLC Suite 410 1130 Northwest 22nd Avenue Portland, OR 97210 United States
Central: Chesapeake Research Review, Inc. Suite 110 7063 Columbia Gateway Drive Columbia, MD 21046-3403 United States
Bennetts Jr., Roland William Buehler, Jeffrey Charles DeGregorio, Barry Thomas Hapke, Ronald Jack Jazrawi, Saad F. Kim, Julie Ann Poorman, Jay Clifford Rollins Black, Katherine Lauren Smith, Matthew Andres Taylor, Derek Carr Vorlop, Erich D. 8
ABT-450/r/ABT-267, ABT-333 M13-389 Clinical Study Report – Final R&D/14/1301
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Gschwantler, Michael (36852)
Wilhelminenspital 4. Medizinische Abteilung Montleartstrasse 37 Vienna, 1160 Austria
Local: Ethikkommission der Stadt Wien Thomas-Klestil-Platz 8 Vienna, 1030 Austria Central: Ethikkommission der Medizinischen Universitaet Wien und des allgemeinen Krankenhauses der Stadt Wien-AKH Borschkegasse 8b/E06 Vienna, 1090 Austria
Dulic-Lakovic, Emina Hellmich, Brigitte Karpi, Asia
Gurel, Selim (40736) (Replaced Nak, Selim Giray [50130])
Uludag University Medical Faculty Department of Internal Diseases Gastroenterology Division Gorukle, Bursa, 16059 Turkey
Central: University of Istanbul Cerrahpasa Faculty of Medicine Klinik Arastirmalar Etik Kurulu Dekanlik Binasi Kocamustafapasa Fatih Istanbul, 34303 Turkey
Nak, Selim Giray Pekgoz, Murat
9
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hakangard, Camilla (47647) (Replaced Bjorkman, Per [45208])
Skanes University Hospital Malmo Infektionskliniken Mottagning Ruth Lundskogsgata 3 Malmo, SE-205 02 Sweden
Central: Regionala etikprovningsnamnden i Stockholm FE 289 Stockholm, 171 77 Sweden
Bjorkman, Per Flamholc, Leo Jerkman, Anna Svensson, Daniel Wallmark, Eva Wiksell, Peter
Horsmans, Yves (45227)
Cliniques Universitaires Saint Luc Avenue Hippocrate 10 Brussels, 1200 Belgium
Central: Comission d'Ethique Biomedicale Hospitalo-Facultaire de UCL Cliniques Universitaires Saint-Luc Tour Harvey niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Starkel, Peter
Koksal, Iftihar (48811)
Karadeniz University Karadeniz Teknik Universitesi Tip Fakultesi Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Anabilim Dali Kalkinma Mah. Trabzon, 61080 Turkey
Central: University of Istanbul Cerrahpasa Faculty of Medicine Klinik Arastirmalar Etik Kurulu Dekanlik Binasi Kocamustafapasa Fatih Istanbul, 34303 Turkey
Yilmaz, Yesmin Yilmaz, Gurdal
10
ABT-450/r/ABT-267, ABT-333 M13-389 Clinical Study Report – Final R&D/14/1301
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Lannergard, Anders (45266) (Site did not enroll)
Uppsala University Hospital Dept. of Infectious Diseases Uppsala, 751 85 Sweden
Central: Regionala etikprovningsnamnden i Stockholm FE 289 Stockholm, 171 77 Sweden
Ljunghill Hedberg, Anna Nystrom Rosander, Christina
Maieron, Andreas (39545)
Krankenhaus der Elisabethinen Linz GmbH 4. Interne Abteilung Fadingerstr. 1 Linz, 4020 Austria
Local: Ethikkommission des Landes Oberoesterreich p.A. OO Landes-Nervenklinik Wagner-Jauregg, Neurochirugie Wagner-Jauregg-Weg 15 Linz, 4020 Austria Central: Ethikkommission der Medizinischen Universitaet Wien und des allgemeinen Krankenhauses der Sadt Wien-AKH Dienstzimmergebaeude, BT 68 Borschkegase 8b/ E06 Vienna, 1090 Austria
Gerstl, Sebastian Hametner, Stephanie Ziachehabi, Alexander
11
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
McNeese, Jason (45214)
Gastrointestinal Associates, P.A. Suite 203 1421 North State Street Jackson, MS 39202 United States
Central: Chesapeake Research Review, Inc. Suite 110 7063 Columbia Gateway Drive Columbia, MD 21046-3403 United States
Dotherow, Pierce D. Gregg, Tina M Hogan II, Reed B. Kotfila, Ronald P. Long, Billy W. McDavid, James P Milner, Paul Petro, Michelle A Reeves-Darby, Vonda G. Runnels, John M Sones II, James Q Underwood Jr., James A Wilson, Mark E. Wright, Cynthia H
Melendez-Rivera, Ivan (32787)
Ararat Research Center Suite 412 8169 Calle Concordia Ponce, 00717-1567 Puerto Rico
Central: Chesapeake Research Review, Inc. Suite 110 7063 Columbia Gateway Drive Columbia, MD 21046-3403 United States
Baco-Davila, Julio A Bedard-Marrero, Valerie Marquez-Minondo, Dianne M Vazquez-Santiago, Carlos A
12
ABT-450/r/ABT-267, ABT-333 M13-389 Clinical Study Report – Final R&D/14/1301
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Moreno, Christophe (45746)
ULB Hospital Erasme Route de Lennik 808 Brussels, 1070 Belgium
Central: Comission d'Ethique Biomedicale Hospitalo-Facultaire de UCL Cliniques Universitaires Saint-Luc Tour Harvey niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Adler, Michael Boon, Nathalie Degre, Delphine Gustot, Thierry Schreiber, Jonas
Muellhaupt, Beat (45610)
University Hospital Zurich Klinik fuer Gastroenterologie und Hepatologie Raemistrasse 100 Zurich, 8091 Switzerland
Local: Kantonale Ethikkommission Zurich Stampfenbachstrasse 121 Zurich, 8090 Switzerland
Haller, Yeri Kuntzen, Thomas
Murray, Natalie (45108) (Site did not enroll)
Baylor All Saints Medical Center 1400 - 8th Avenue Fort Worth, TX 76017 United States
Local: Baylor Research Institute IRB Suite 501 3310 Live Oak Dallas, TX 75246 United States
Acker, Michelle Edwards, Jonnie Fassett, Erin Gautam, Manjushree Gonzalez, Stevan Modi, Apurva Purcell, Kerri Roy, Angela Saucier, Jessica
13
ABT-450/r/ABT-267, ABT-333 M13-389 Clinical Study Report – Final R&D/14/1301
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Nak, Selim Giray (50130) (Replaced by Gurel, Selim [40736])
Uludag University Medical Faculty Department of Internal Diseases Gastroenterology Division Gorukle, Bursa, 16059 Turkey
Central: University of Istanbul Cerrahpasa Faculty of Medicine Klinik Arastirmalar Etik Kurulu Dekanlik Binasi Kocamustafapasa Fatih Istanbul, 34303 Turkey
Gurel, Selim Pekgoz, Murat
Nevens, Frederik (45199)
Universitair Ziekenhuis Leuven Herestraat 49 Leuven, 3000 Belgium
Central: Comission d'Ethique Biomedicale Hospitalo-Facultaire de UCL Cliniques Universitaires Saint-Luc Tour Harvey niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Cassiman, David Laleman, Wim Van Steenbergen, Werner Van der Merwe, Schalk Verslype, Chris
Norkrans, Gunnar (45264)
Sahlgrenska University Hospital Dept. of Infectious Diseases Byggnad IK Osra Sjuhuset Smorslottsgatan 1 Gothenburg, 416 85 Sweden
Central: Regionala etikprovningsnamnden i Stockholm FE 289 Stockholm, 171 77 Sweden
Eilard, Anders Lagging, Martin Lindh, Magnus Wejstal, Rune Westin, Johan
14
ABT-450/r/ABT-267, ABT-333 M13-389 Clinical Study Report – Final R&D/14/1301
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Osiyemi, Olayemi (37536) (Site did not enroll)
Triple O Research Institute, P.A. Suite 200 1515 North Flagler Drive West Palm Beach, FL 33401 United States
Central: Chesapeake Research Review, Inc. Suite 110 7063 Columbia Gateway Drive Columbia, MD 21046-3403 United States
Kuretski, Jennifer L. Menajovsky-Chaves, Jose
Ozaras, Resat (48812)
University of Istanbul Cerrahpasa Faculty of Medicine Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Anabilim Dali Kocamustafapasa Fatih Istanbul, 34303 Turkey
Central: University of Istanbul Cerrahpasa Faculty of Medicine Klinik Arastirmalar Etik Kurulu Dekanlik Binasi Kocamustafapasa Fatih Istanbul, 34303 Turkey
Tabak, Omer Fehmi Yemisen, Mucahit
Pruitt, Ronald (7123)
Nashville Medical Research Institute Suite 529 4230 Harding Road Nashville, TN 37205 United States
Central: Chesapeake Research Review, Inc. Suite 110 7063 Columbia Gateway Drive Columbia, MD 21046-3403 United States
Jacobus, Danelle
15
ABT-450/r/ABT-267, ABT-333 M13-389 Clinical Study Report – Final R&D/14/1301
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Raimondo, Giovanni (45529)
AO Universitaria di Messina Policlinico G. Martino U.O.C. di Epatologia Clinica e Biomolecolare Via Consolare Valeria, 1 Messina, 98124 Italy
Local: AO Universitaria di Messina Policlinico G. Martino Comitato Etico Interaziendale della Provincia di Messina Via Consolare Valeria, 1, Gazzi Messina, 98125 Italy
Cacciola, Irene Filomia, Roberto Maimone, Sergio Saitta, Carlo Squadrito, Giovanni
Reesink, Hendrik (45200)
Academisch Medisch Centrum Universiteit van Amsterdam Meibergdreef 9 Amsterdam, 1105 AZ Netherlands
Central: Academisch Medisch Centrum Medisch Ethische Commissie Meibergdreef 9 Amsterdam, 1105 AZ Netherlands
Jansen, Louis Willemse, Sophie Bertine van der Ree, Meike Henriette
Reynaert, Hendrik (45197)
UZ VUB Universitair Ziekenhuis Vrije Universiteit Brussels Laarbeeklaan 101 Brussels, 1090 Belgium
Central: Comission d'Ethique Biomedicale Hospitalo-Facultaire de UCL Cliniques Universitaires Saint-Luc Tour Harvey niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Aerts, Maridi
16
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Rodriguez-Perez, Federico (45122)
Gastroenterology and Hepatic Wellness Center Office 303 1420 Americo Salas Street Santurce, 00909 Puerto Rico
Central: Chesapeake Research Review, Inc. Suite 110 7063 Columbia Gateway Drive Columbia, MD 21046-3403 United States
Bigio, Johanna
Rossaro, Lorenzo (40602) (Replaced by Bowlus, Christopher [53094])
University of California Davis GI/Hepatology CTU Suite 100 2000 Stockton Boulevard Sacramento, CA 95817 United States
Local: University of California Davis UC Davis- IRB Administration CTSC Building, Room 1429, Suite 1400 2921 Stockton Boulevard Sacramento, CA 95817 United States
Bowlus, Christopher L Lester, Laura
Smith, Coleman (38847) (Site did not enroll)
Minnesota Gastroenterology, P.A. Suite 423 South 2550 University Avenue West St. Paul, MN 55114 United States
Central: Chesapeake Research Review, Inc. Suite 110 7063 Columbia Gateway Drive Columbia, MD 21046-3403 United States
Boldt, Mark Feldshon, S. David Storrs, Gina Waller, Amy
17
ABT-450/r/ABT-267, ABT-333 M13-389 Clinical Study Report – Final R&D/14/1301
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Tato Marinho, Rui (46971)
Hospital de Santa Maria Servico de Gastrenterologia e Hepatologia Centro Hospitalar de Lisboa Norte, EPE Avenida Prof. Egas Moniz Lisbon, 1649-035 Portugal
Central: CEIC - Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Ferreira, Paula Noronha Ferreira, Carlos Vieira, Catarina
Van Vlierberghe, Hans (38878)
University Hospital Ghent, UZ Ghent De Pintelaan 185 Ghent, 9000 Belgium
Central: Comission d'Ethique Biomedicale Hospitalo-Facultaire de UCL Cliniques Universitaires Saint-Luc Tour Harvey niveau 0 Avenue Hippocrate 55.14 Brussels, 1200 Belgium
Geerts, Anja Verhelst, Xavier
Vierling, John (38851)
St. Lukes Episcopal Hospital St. Luke's Advanced Liver Therapies Suite 1505 6620 Main Street Houston, TX 77030 United States
Local: Biomedical Research Alliance of New York, LLC Biomedical Research Alliance of New York Suite 210 1981 Marcus Ave. Lake Success, NY 11042 United States
Dietrich,Beth Hollinger, F . Blaine Jalal, Prasun Kumar Sood, Gagan K. Stribling, Rise J. Sussman, Norman L. Westergren, Paula
18
ABT-450/r/ABT-267, ABT-333 M13-389 Clinical Study Report – Final R&D/14/1301
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Vogel, Wolfgang (35508)
Medical University of Innsbruck Universitaetsklinik fuer Innere Medizin II Klinische Abteilung fuer Gastroenterologie & Hepatologie Anichstrasse 35 Innsbruck, 6020 Austria
Local: Medical University of Innsbruck Ethikkommission Innrain 43 Innsbruck, 6020 Austria Central: Ethikkommission der Medizinischen Universitaet Wien und des allgemeinen Krankenhauses der Stadt Wien-AKH Borschkegasse 8b/E06 Vienna, 1090 Austria
Millonig, Gunda Nachbaur, Karin
Weiland, Ola (45207)
Karolinska University Hospital Huddinge, Div. of Infectious Diseases 173 Stockholm, 141 86 Sweden
Local: Regionala etikprovningsnamnden i Stockholm FE 289 Stockholm, SE-171 77 Sweden
Aleman, Soo Lindahl, Karin
19
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List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Weinstein, Debra (33315)
ZASA Clinical Research Suite 204 8188 Jog Road Boynton Beach, FL 33472 United States
Central: Chesapeake Research Review, Inc. Suite 110 7063 Columbia Gateway Drive Columbia, MD 21046-3403 United States
Aqua, Keith A. Hurwitz, Lyle K Salomon, Peter Shanmugam, Nirmala
Younossi, Zobair (45110) (Site did not enroll)
Inova Fairfax Hospital Center for Liver Diseases 3300 Gallows Road Falls Church, VA 22042 United States
Local: Western Institutional Review Board (WIRB) 3535 Seventh Avenue Southwest Olympia, WA 98502-5010 United States
Afendy, Mariam Y. Cable, Rebecca A. Cooper, James N. Lam, Brian P. Mir, Heshaam Mishra, Alita Nader, Fatema H.
Yurdaydin, Cihan (40734)
Ankara University Medical Faculty Cebeci Research and Training Hospital Department of Internal Diseases, Gastroenterology Division Dikimevi Ankara, Turkey
Central: University of Istanbul Cerrahpasa Faculty of Medicine Klinik Arastirmalar Etik Kurulu Dekanlik Binasi Kocamustafapasa Fatih Istanbul, 34303 Turkey
Idilman, Ramazan Keskin, Onur
20
ABT-450/r/ABT-267, ABT-333 M13-389 Clinical Study Report – Final R&D/14/1301
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Zamor, Philippe (49267)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Center for Liver Disease Suite 600 1025 Morehead Medical Drive Charlotte, NC 28204 United States
Local: Copernicus Group IRB PO Box 110605 Suite 100 One Triangle Drive Research Triangle Drive, NC 27709 United States
Bonkovsky, Herbert Conner, Gregory McFadden, Regina Russo, Mark Schmeltzer, Paul
21
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16.1__4
Investigators and Other Important Participants in the Study
16.1__4.1
List and Description of Investigators
1
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Al-Osaimi, Abdullah (52569) (Replaced Patel, Vishal [48934])
Temple University Hospital Kresge West 2nd Floor 3440 North Broad Street Philadelphia, PA 19140 United States
Local: Western Institutional Review Board (WIRB) Suite 120 1019 39th Avenue Southeast Puyallup, WA 98374-2115 United States
Jesudoss, Randhir Musa, Hawah Vasquez, Jessica
Balart, Luis (19981)
Tulane University Health Sciences Center Department of Medicine Section of Gastroenterology SL 35 1430 Tulane Avenue New Orleans, LA 70112 United States
Local: Tulane University Health Sciences Center Tulane University Human Research Protection Office Suite 1706, TW-36 1440 Canal Street New Orleans, LA 70112 United States
Hengl, Lauri Miller, Ward Moehlen, Martin Shores, Nathan
Baruch, Yaacov (47627)
Rambam Health Care Campus Liver Disease Unit 6 Ha'aliya St. Haifa, 31096 Israel
Local: Rambam Health Care Campus Ethic Committee 6 Ha'aliya St. Haifa, 31096 Israel
Saadi, Tarek Vaysbuch, Felix
Ben-Ari, Ziv (47629)
The Chaim Sheba Medical Center Tel Hashomer Ramat Gan, 52621 Israel
Local: The Chaim Sheba Medical Center Ethics Committee Tel Hashomer Ramat Gan, 52621 Israel
Berdichevski, Tania Cohen-Ezra,Oranit Veitsman, Ella Weiss, Peretz
2
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Bernstein, David (38853)
North Shore-LIJ Health System Division of Gastroenterology 4 Levitt 300 Community Manhasset, NY 11030 United States
Local: Biomedical Research Alliance of New York, LLC Biomedical Research Alliance of New York Suite 210 1981 Marcus Ave. Lake Success, NY 11042 United States
DeVito, Bethany S. Duddempudi, Anupama T. Khodadadian, Edna Tiev, Maly
Bourgeois, Stefan (47437)
ZNA Stuivenberg SGS CPU Lange Beeldekensstraat 267 Antwerp, 2060 Belgium
Central: University Hospital Ghent, UZ Ghent Etisch Comite De Pintelaan 185 Ghent, 9000 Belgium
Anthone, Nancy Gheyle, Lien Haazen, Wouter Leempoels, Jos Mesens, Sofie Petkova, Magdalena Ramael, Steven Vets, Eva
Box, Terry (20229)
Clinical Research Centers of America, LLC Suite B 5450 South Green Street Murray, UT 84123 United States
Central: Quorum Review IRB 1601 Fifth Avenue Seattle, WA 98101 United States
Cobb, Deborah Deans, Amy Little, Susan Munk, Heather Stevens, Kerin Strong, Sharon Thomason, I. Raymond Waddoups, Lindsey
3
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Calinas, Filipe (47040)
Hospital Santo Antonio dos Capuchos Servico de Gastroenterologia Centro Hospitalar de Lisboa Central, EPE Alameda Santo Antonio dos Capuchos Lisbon, 1169-050 Portugal
Central: CEIC – Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Costa, Mariana
Calleja Panero, Jose (44372)
Hospital Universitario Puerta de Hierro Majadahonda Planta 3 Digestivo C/Manuel de Falla, No. 1 Majadahonda, Madrid, 28220 Spain
Local: Hospital Universitario Puerta de Hierro Majadahonda CEIC C/Manuel de Falla, 1 Majadahonda (Madrid), 28220 Spain
Martinez, Jose Luis de la Revilla, Juan
Central: Hospital Universitarrio Puerta de Hierro Majadahonda CEIC C/Manuel de Falla, 2, Majadahonda Madrid, 28222 Spain
4
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Caruntu, Florin (47495)
Institutul National de Boli Infectioase Prof. Matei Bals (Site 1) Sector 2 Str. Dr. Calistrat Grozovici nr. 1 Bucharest, 021105 Romania
Central: Comisia Nationala de Bioetica a Medicamentului Str. Aviator Sanatescu nr. 48 Bucharest, 011478 Romania
Radu, Monica Nicoleta
Carvalho, Armando (47041) (Site did not enroll)
Centro Hospitalar e Universitario de Coimbra, EPE Servico de Medicina III Avenida Bissaya Barreto Coimbra, 3000-075 Portugal
Central: CEIC – Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Correia, Lurdes Simao, Adelia
5
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Chulanov, Vladimir (47503)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Central Scientific and Research Institute of Epidemiology Central Budgetary Scientific Institution 3a Novogireevskaya str. Moscow, 111123 Russian Federation
Local: Central Scientific and Research Institute of Epidemiology Local Ethics Committee of Central Butgetary Scientific Institution 3a Novogireevskaya str. Moscow, 111123 Russian Federation
Batskikh, Sergey Mamonova, Nina Sukhareva, Galina Sviridova, Maria
Central: Ethics Counsel under the Ministry of Healthcare 3, Rakhmanovskiy pereulok Moscow, 127994 Russian Federation Crespo, Israel (42806)
Advanced Research Institute, Inc. 7114 Congress Street New Port Richey, FL 34653 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Amar, Sivakumar Arel, Christina Condit, Allison A. Cruz, Jose L. Henderson, Gabrielle Randall, Susan Rodriguez, Daniel H. Rosario, Angel Scanlin, Audrey
6
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Curescu, Manuela (47538)
Life Search SRL Str. Gheorghe Baritiu nr. 40, Judet Timis Timisoara, 300167 Romania
Central: Comisia Nationala de Bioetica a Medicamentului Str. Aviator Sanatescu nr. 48 Bucharest, 011478 Romania
Cerbu, Elena Bianca Iosifescu, Elena
Diago Madrid, Moises (40766)
Hospital Quiron de Valencia Unidad de Hepatologia Servicio de Aparato Digestivo Avenida Blasco Ibanez, 10 Valencia, 46014 Spain
Central: Hospital Universitarrio Puerta de Hierro Majadahonda CEIC C/Manuel de Falla, 1, Majadahonda Madrid, 28222 Spain
Moreno Martin, Maria Luisa Perez Anton, Celia
Local: Hospital de la Ribera CEIC Ctra. Corbera, Km 0 Alzira (Valencia), 46600 Spain
7
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Enayati, Pedram (40076)
Cedars-Sinai Medical Center Dr. Pedram Enayati Suite 1020E 8631 West 3rd Street Los Angeles, CA 90048 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Mathew, Lucy
Ferenci, Peter (45268)
Medical University of Vienna Klinische Abteilung fuer Gastroenterologie und Hepatologie Univ. Klinik f. Innere Medizin III Waehringer Guertel 18-20 Vienna, 1090 Austria
Local: Medical University of Vienna Ethikkommission der Medizinischen Universitaet Wien und des Allgemeinen Krankenhauses der Stadt Wien Borschkegasse 8b/E06 Vienna, 1090 Austria
Beinhardt, Sandra Hofer, Harald Kozbial, Karin Munda, Petra Rutter, Karoline Scherzer, Thomas Matthias Staettermayer, Albert Friedrich Strassl, Robert Paul Trattner, Hannes
Central: Ethikkommission des Landes Oberoesterreich p.A. OO Landes-Nervenklinik Wagner-Jauregg, Neurochirugie Wagner-Jauregg-Weg 15 Linz, 4020 Austria
8
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Gervain, Judit (47727)
Fejer Megyei Szent Gyorgy Korhaz Seregelyesi u. 3 Szekesfehervar, H-8000 Hungary
Central: Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga Arany Janos utca 6-8 Budapest, 1051 Hungary
Nyikos, Orsolya
Gschwantler, Michael (36852)
Wilhelminenspital 4. Medizinische Abteilung Montleartstrasse 37 Vienna, 1160 Austria
Local: Ethikkommission der Stadt Wien MA 15 – Gesundheitsdienst der Stadt Wien Stiege 2, 1. Stock Schnirchgasse 12/2 Vienna, 1030 Austria
Dulic-Lakovic, Emina Hellmich, Brigitte Karpi, Asia
Central: Ethikkommission des Landes Oberoesterreich p.A. OO Landes-Nervenklinik Wagner-Jauregg, Neurochirugie Wagner-Jauregg-Weg 15 Linz, 4020 Austria
9
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Janczewska, Ewa (48066)
ID Clinic ul. Janowska 19 Myslowice, 41-400 Poland
Central: Komisja Bioetyczna Slaskiej Izby Lekarskiej w Katowicach ul. Grazynskiego 49a Katowice, 40-126 Poland
Adamek, Brygida Piotrowski, Damian Pisula, Arkadiusz
Lidofsky, Steven (47045)
Fletcher Allen Health Care, Inc. 1 South Prospect Street Burlington, VT 05401 United States
Local: University of Vermont Committees on Human Research 213 Waterman Building 85 South Prospect Street Burlington, VT 05401 United States
Anderson, Kathryn Ferrentino, Nicholas Parker, Erin Strader, Doris
Luketic, Velimir (46991)
West Hospital PO Box 980341 Room 1483 1200 East Broad Street Richmond, VA 23298-0341 United States
Local: Western Institutional Review Board (WIRB) 3535 Seventh Avenue Southwest Olympia, WA 98502-5010 United States
Bouneva, Iliana Simeonova Genther, Kathleen Puri, Puneet Sanyal, Arun Jayant Siddiqui, Mohammad Shadab Smith, Paula Sterling, Richard Keith Stravitz, Richard Todd
10
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Lurie, Yoav (47628)
Shaare Zedek Medical Center Liver Disease Unit Digestive Disease Institute 12 Bayit Street 91031 Jerusalem, 93722 Israel
Local: Shaare Zedek Medical Center Ethic Committee 12 Bayit Street 91031 Jersusalem, 93722 Israel
Adar, Tomer Gafanovich, Inna Koslowsky, Benjamin Mahmud, Mahamid Meir Livovsky, Dan Melamud, Bernardo
Macedo, Guilherme (34984) (Site did not enroll)
Centro Hospitalar de Sao Joao, E.P.E. Servico de Gastroenterologia Alameda Prof. Hernani Monteiro Porto, 4200-319 Portugal
Central: CEIC – Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Antunes, Claudio Cardoso, Helder Pinto, Eduardo
Maieron, Andreas (39545)
Krankenhaus der Elisabethinen Linz GmbH 4. Interne Abteilung Fadingerstr. 1 Linz, 4020 Austria
Central: Ethikkommission des Landes Oberoesterreich p.A. OO Landes-Nervenklinik Wagner-Jauregg, Neurochirugie Wagner-Jauregg-Weg 15 Linz, 4020 Austria
Gerstl, Sebastian Hametner, Stephanie Ziachehabi, Alexander
11
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Mantry, Parvez (40545)
The Liver Institute at Methodist Dallas Pavilion III, Suite 268 1411 North Beckley Avenue Dallas, TX 75203 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Nazario, Hector Ndungu, Milka Ryan, Laura Teachenor, Olga Weinstein, Jeffrey Wu, Chunxia (Spring)
Marbury, Thomas (13231)
Orlando Clinical Research Center 5055 South Orange Avenue Orlando, FL 32809 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Anderson, Kristan M. Bastedo, Kimberly A. Chao, Helen H. Garcia, Charmaine R. Roush, Conni Shah, Daminee R. Stonerock, Jr., Robert F. Wezel, Germaine Gigi
Mayevskaya, Marina (47504)
Clinic Propedeutics Internal Diseases na V.H. Vasilenko of Moscow States Medical University na I.M. Sechenov Gastroenterology and Hepatology, Building 1 1 Pogodinskaya str. Moscow, 119435 Russian Federation
Central: Ethics Counsel under the Ministry of Healthcare 3 Rakhmanovskiy pereulok Moscow, 127994 Russian Federation
Fedosyina, Ekaterina Lapshin, Alexey Tikhonov, Igor
Local: Interacademic Ethics Committee Building 2 37, Gagarinskiy pr. Moscow, 119002 Russian Federation 12
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Mazur, Wlodzimierz (45472)
Szpital Specjalistyczny w Chorzowie Oddzial Obserwacyjno-Zakazny, Hepatologil Zakaznej i Nabytych Niedoborow Odpornosci – Kliniczny ul. Zjednoczenia 10 Chorzow, 41-500 Poland
Central: Komisja Bioetyczna Slaskiej Izby Lekarskiej w Katowicach ul. Grazynskiego 49a Katowice, 40-126 Poland
Logiewa-Bazger, Beata Meier, Dorota Zasik, Ewelina
Moreno, Christophe (45746)
ULB Hospital Erasme Route de Lennik 808 Brussels, 1070 Belgium
Central: University Hospital Ghent, UZ Ghent Etisch Comite De Pintelaan 185 Ghent, 9000 Belgium
Adler, Michael Boon, Nathalie Degre, Delphine Gustot, Thierry Schreiber, Jonas
Mulkay, Jean-Pierre (45465)
CHU St. Pierre Rue Haute 322 Brussels, 1000 Belgium
Central: University Hospital Ghent, UZ Ghent Etisch Comite De Pintelaan 185 Ghent, 9000 Belgium
Serste, Thomas Van Gossum, Marc
Nevens, Frederik (45199)
Universitair Ziekenhuis Leuven Herestraat 49 Leuven, 3000 Belgium
Central: University Hospital Ghent, UZ Ghent Etisch Comite De Pintelaan 185 Ghent, 9000 Belgium
Cassiman, David Laleman, Wim Van der Merwe, Schalk Verslype, Chris
13
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Nyberg, Anders (48174)
Kaiser Permanente Hepatology Research Building 4, 1st Floor, Room 1204 400 Craven Road San Marcos, CA 92069 United States
Local: Kaiser Permanente Southern California Institutional Review Board 2nd Floor 393 East Walnut Street Pasadena, CA 91188 United States
Farb, Brian S. Nyberg, Lisa M. Rathbun, Robert A.
Nyberg, Lisa (45260)
Kaiser Permanente Hepatology Research 3rd Floor 4650 Palm Avenue San Diego, CA 92154 United States
Local: Kaiser Permanente Southern California Institutional Review Board 2nd Floor 393 East Walnut Street Pasadena, CA 91188 United States
Farb, Brian S. Nyberg, Anders H. Rathbun, Robert A.
Olszok, Iwona (47494)
Szpital Rejonowy Oddzial Obserwacyjno-Zakazny ul. Garnowska 3 Raciborz, 47-400 Poland
Central: Komisja Bioetyczna Slaskiej Izby Lekarskiej w Katowicach ul. Grazynskiego 49a Katowice, 40-126 Poland
Bluszcz-Roznowska, Anita Lubszczyk, Teresa
Patel, Vishal (48934) (Replaced by Al-Osaimi, Abdullah [52569])
Temple University Hospital Kresge West 2nd Floor 3440 North Broad Street Philadelphia, PA 19140 United States
Local: Western Institutional Review Board (WIRB) 3535 7th Ave SW Olympia, WA 98502 United States
Al-Osaimi, Abdullah Jesudoss, Randhir Joseph, Rejy
14
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Pearlman, Brian (46815)
Atlanta Medical Center Institutional Suite 525 285 Boulevard Northeast Atlanta, GA 30312 United States
Local: Atlanta Medical Center Institutional Box 233 303 Parkway Drive Atlanta, GA 30312 United States
Frilingos, Daniel Maxwell, Sharli Traub, Nomi
Planas Vila, Ramon (45225)
Hospital Universitario Germans Trias i Pujol Servicio de Digestivo Edificio General 5a planta Carretera del Canyet, s/n Badalona – Barcelona, 08916 Spain
Central: Hospital Universitarrio Puerta de Hierro Majadahonda CEIC C/Manuel de Falla, 2, Majadahonda Madrid, 28222 Spain
Morillas Cunill, Rosa Maria
Local: Hospital Universitario Germans Trias i Pujol Comite Etico de Investigacion Clinica Ctra. de Canyet, s/n Badalona – Barcelona, 08916 Spain
15
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Puoti, Massimo (45204)
A.O. Ospedale Niguarda Ca Granda Struttura Complessa di Malattie Infettive Piazza Ospedale Maggiore, 3 Milan, 20162 Italy
Local: A.O. Ospedale Niguarda Ca Granda Comitato Etico Milano Area C Piazza Ospedale Maggiore, 3 Milan, 20162 Italy
Bai, Francesca Cocca, Giorgia Foschi, Antonella Moioli, Maria Cristina Orso, Maurizio Rossotti, Roberto Travi, Giovanna Vinci,Maria
Reddy, K. Rajender (38629) *Investigator is listed as "Reddy, K." in the clinical database.
University of Pennsylvania Gastroenterology Research 3400 Spruce Street Philadelphia, PA 19104 United States
Local: University of Pennsylvania Office of Regulatory Affairs Suite 301 South 3624 Market Street Philadelphia, PA 19104 United States
Appolo, Brenda Krok, Karen Makar, George Sinese, Lorie
Rizzardini, Giuliano (17127)
Azienda Ospedaliera Luigi Sacco I Divisione Malattie Infettive pad. 56 Via G. B. Grassi 74 Milan, 20157 Italy
Local: Azienda Ospedaliera Luigi Sacco Comitato Etico Interaziendale Milano Area A Via G.B.Grassi, 74 Milan, 20157 Italy
Angeli, Elena Gubertini, Guido Magni, Carlo Mainini, Annalisa Niero, Fosca Schiavini, Monica
16
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Romero Gomez, Manuel (44436)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hospital Universitario Nuestra Senora de Valme Servicio de Digestivo Carretera de Cadiz, Km. 548,9 Seville, 41014 Spain
Central: Hospital Universitarrio Puerta de Hierro Majadahonda CEIC C/Manuel de Falla, 2, Majadahonda Madrid, 28222 Spain
Aparcero Lopez, Reyes Calle Sanz, Raquel
Local: Hospital Universitario Nuestra Senora de Valme Comite Etico de Investigacion Clinica Carretera de Cadiz, Km. 548.9 Seville, 41014 Spain Rugina, Sorin (16163)
Spitalul Clinic de Boli Infectioase Constanta Str. Ferdinand nr 100 Constanta, 900708 Romania
Central: Comisia Nationala de Bioetica a Medicamentului Str. Aviator Sanatescu nr. 48 Bucharest, 011478 Romania
Dumea, Elena Dumitru, Irina
17
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Sarmento e Castro, Rui (47042)
Hospital Joaquim Urbano Servico de Doencas Infecciosas Centro Hospitalar do Porto, EPE Rua Camara Pestana 348 Porto, 4369-004 Portugal
Central: CEIC – Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Mendez, Josefina Silva, Ana Rita
Schneider, Ferenc (47501)
Vas Megyei Markusovszky Lajos Korhaz Nonprofit Zrt. Markusovszky u. 5 Szombathely, H-9700 Hungary
Central: Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga Arany Janos utca 6-8 Budapest, H-1051 Hungary
Gabor, Beata
Streinu-Cercel, Adrian (16164)
Institutul National de Boli Infectioase Prof. Matei Bals (Site 2) Sector 2 Str. Dr. Calistrat Grozovici nr. 1 Bucharest, 021105 Romania
Central: Comisia Nationala de Bioetica a Medicamentului Str. Aviator Sanatescu nr. 48 Bucharest, 011478 Romania
Manolache, Daniela Streinu-Cercel, Oana Streinu-Cercel, Anca
Szalay, Ferenc (47502)
Semmelweis Egyetem AOK I. sz. Belgyogyaszati Klinika Koranyi Sandor u. 2/A Budapest, H-1083 Hungary
Central: Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga Arany Janos utca 6-8 Budapest, 1051 Hungary
Abonyi, Margit Toth, Tamas
18
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Tato Marinho, Rui (46971)
Hospital de Santa Maria Servico de Gastrenterologia e Hepatologia Centro Hospitalar de Lisboa Norte, EPE Avenida Prof. Egas Moniz Lisbon, 1649-035 Portugal
Central: CEIC – Comissao de Etica para Investigacao Clinica Parque da Saude de Lisboa Pav. 17-A Av. do Brasil, 53 Lisbon, 1749-004 Portugal
Ferreira, Paula Noronha Ferreira, Carlos Vieira, Catarina
Van Vlierberghe, Hans (38878)
University Hospital Ghent, UZ Ghent De Pintelaan 185 Ghent, 9000 Belgium
Central: University Hospital Ghent, UZ Ghent Etisch Comite De Pintelaan 185 Ghent, 9000 Belgium
Geerts, Anja Verhelst, Xavier
Villa, Erica (47726)
A.O.U. Policlinico di Modena U.O. Gastroenterologia Via del Pozzo, 71 Modena, 41124 Italy
Local: A.O.U. Policlinico di Modena Comitato Etico Provinciale di Modena Via del Pozzo, 71 Modena, 41124 Italy
Bernabucci, Veronica Di Girolamo, Maria Marocchi, Margherita Sartini, Alessandro Turco, Laura de Maria, Nicola
19
ABT-450/r/ABT-267, ABT-333 M13-961 Clinical Study Report – Final R&D/14/1305
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Yakovlev, Alexey (35301)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Infectious Diseases Hospital n.a. S.P. Botkin 3, Mirgorodskaya str. St. Petersburg, 191167 Russian Federation
Local: Infectious Diseases Hospital n.a. S.P. Botkin Ethics Committee 3, Mirgorodskaya str. St. Petersburg, 191167 Russian Federation
Firsov, Sergey Komarova, Alexandra Musatov, Vladimir Sokolova, Olga
Central: Ethics Counsel under the Ministry of Healthcare 3, Rakhmanovskiy pereulok Moscow, 127994 Russian Federation Yangco, Bienvenido (2115)
Infectious Disease Research Institute Inc. Suite 203 4620 North Habana Avenue Tampa, FL 33614 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Chagaris, Kalliope D.
Younes, Ziad (22887)
Gastroenterology Center of the MidSouth, P.C. 310 Wolf Park Drive Germantown, TN 38138 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Elsakr, Raif W. Leal, Rolando J. Pop, Anca I. Wooten, Robert S.
20
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
16.1__4
Investigators and Other Important Participants in the Study
16.1__4.1
List and Description of Investigators
1
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Aspinall, Richard (48961)
Queen Alexandra Hospital Department of Gastroenterology & Hepatology Southwick Hill Road, Cosham, Hampshire Portsmouth, PO6 3LY United Kingdom
Central: NRES Committee London - City and East South West REC Centre, Level 3, Block B Whitefriars, Lewins Mead Bristol, BS1 2NT United Kingdom
Fowell, Andrew Levick, Christine
Bennett, Michael (31542)
Medical Associates Research Group Suite 200 8008 Frost Street San Diego, CA 92123 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Flores, Sergio R. Kim, Hyun S. Politoske, Douglas A. Pressman, Jeffrey H. Snyder, Richard J. Tuohy, Dianne
Bernstein, David (38853)
North Shore-Long Island Jewish Health System 300 Community Drive Manhasset, NY 11030 United States
Local: Biomedical Research Alliance of New York, LLC Biomedical Research Alliance of New York Suite 210 1981 Marcus Ave. Lake Success, NY 11042 United States
DeVito, Bethany S. Duddempudi, Anupama T. Khodadadian, Edna Martins, Jovy Palmer, Radica Tiev, Maly
2
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Bhandari, Bal Raj (45219)
Delta Research Partners, LLC 616 South Washington Street Bastrop, LA 71220 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Carpenter, Bridgett Hill Hinkle III, Henry McCullars, Melissa Petrus, Casey
Box, Terry (20229)
Clinical Research Centers of America, LLC Suite B 5450 South Green Street Murray, UT 84123 United States
Central: Quorum Review IRB PO Box 84572 Seattle, WA 98101 United States
Cobb, Deborah Deans, Amy Little, Susan Munk, Heather Stevens, Kerin Strong, Sharon Thomason, I. Raymond Waddoups, Lindsey
Bredeek, U. Fritz (33471)
Metropolis Medical Group Suite 301 815 Hyde Street San Francisco, CA 94109 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Berdy, Sara Taylor, Bonnie L. Walker, Erin
3
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Brown, Ashley (47009)
St. Marys Hospital Liver and Anti-Viral Unit 10th Floor, Queen Elizabeth The Queen Mother Building (QEQM) Praed Street London, W2 1NY United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Nieddu, Paolo Selvapatt, Nowlan
Cooper, Curtis (21909)
Ottawa Hospital 501 Smyth Road Ottawa, ON K1H 8L6 Canada
Local: Ottawa Hospital Research Ethics Board (OHREB) Civic Campus 751 Parkdale Avenue Ottawa, ON K1Y 4E9 Canada
Garber, Gary E. Hodgins, Michael Lee, Craig
Cote, Pierre (48973)
Clinique Medicale du Quartier Latin 905 Boulevard Rene-Levesque Est Montreal, QC H2L 5B1 Canada
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Baril, Jean-Guy Charron, Marc-Andre Dufresne, Serge Laplante, Francois Lessard, Bernard Pilarski, Robert Poirier, Denis Sasseville, Elise Tessier, Dominique
4
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Cramp, Matthew (48962)
Derriford Hospital South West Liver Unit Level 7 Devon Plymouth, PL6 8DH United Kingdom
Central: NRES Committee London - City and East South West REC Centre, Level 3, Block B Whitefriars, Lewins Mead Bristol, BS1 2NT United Kingdom
Ahmed, Asma Smith, Aileen Vine, Louisa Warshow, Usama
Davis, Mitchell (40605)
South Florida Center of Gastroenterology, P.A. Suite #205 1447 Medical Park Boulevard Wellington, FL 33414 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Sacks, Steven R Smith, Matthew J. Wahl, Joan K.
Dusheiko, Geoffrey (42783)
The Royal Free Hospital Division of Medicine Centre for Hepatology Pond Street London, NW3 2QG United Kingdom
Central: NRES Committee London - City and East South West REC Centre, Level 3, Block B Whitefriars, Lewins Mead Bristol, BS1 2NT United Kingdom
Burney, Tabinda Rosenberg, William
5
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Eisner, Mark (12338)
Florida Medical Clinic, PA Clinical Research Division 38135 Market Square Zephyrhills, FL 33542 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Chami, Tawfik N. Ellis, Sandi L. Johnston, William Daily Sikes, David Hilton Singh, Soloman R.
Elkhashab, Magdy (49101)
Toronto Liver Centre 2nd Floor 1664 Dufferin Street Toronto, ON M6H 3M1 Canada
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
None
Fessel, W. Jeffrey (48778)
Kaiser Permanente Medical Center, Clinical Trials Unit Suite 219 4141 Geary Boulevard San Francisco, CA 94118 United States
Local: Kaiser Permanente Northern California IRB, Kaiser Foundation Research Institute 16th Floor 1800 Harrison Street Oakland, CA 94612-3431 United States
Anderson, Brooke Casias, Cristina Dillon, Aileen Follansbee, Stephen Hare, Charles Bradley Mettinger, Miki
6
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Forton, Daniel (48960)
St. George's Hospital Department of Gastroenterology and Hepatology Blackshaw Road, Tooting London, SW17 0QT United Kingdom
Central: NRES Committee London - City and East South West REC Centre, Level 3, Block B Whitefriars, Lewins Mead Bristol, BS1 2NT United Kingdom
Cowan, Matthew
Foxton, Matthew (48959)
Chelsea and Westminster Hospital 369 Fulham Road London, SW10 9NH United Kingdom
Central: NRES Committee London - London Bridge, Health Research Authority Ground Floor, Skipton House 80 London Road London, SE1 6LH United Kingdom
Jackson, Akil Jagjit Singh, Gurmit Yapa, Manisha
Freilich, Bradley (22854)
Kansas City Research Institute Suite 430 6675 Holmes Road Kansas City, MO 64131 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Kissinger, Janay A.
7
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Gathe, Jr., Joseph (14636)
Cure C Consortium 4900 Fannin Street Houston, TX 77004 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Clemmons Jr., John B. Mayberry, Carl C
Geenen, Daniel (12676)
Wisconsin Center for Advanced Research GI Associates, LLC GI Associates, LLC Suite 1030 2801 West Kinnickinnic River Parkway Milwaukee, WI 53215 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Anderson, Katherine A. Caskey, Susan Catalano, Marc F. Dombeck, Krista Guda, Nalini M. Kumar, Shiva Paul, Louise E. Pytel, Melissa L. Schmalz, Michael Johannes Stolowski, Jeanne Zvara, Lisa M.
Green, Sinikka (48574)
eStudySite 5565 Grossmont Center Drive Building 3, Suite 525 La Mesa, CA 91942 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Chu, Hanh Gill, John C. Korn, Errol R. Lee, Kia Manos, Paul J. McManus, Alison J. O'Riordan, William D. Overcash, J. Scott
8
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Hanje, James (48575)
The Ohio State University Wexner Medical Center Suite 210 395 West 12th Avenue Columbus, OH 43210 United States
Local: Western Institutional Review Board (WIRB) 3535 Seventh Avenue Southwest Olympia, WA 98508 United States
Kibbe, Pamella Levin, Douglas O'Bleness, Nicole Sleppy, Cynthia
Hanson, John (19986)
Charlotte Gastroenterology and Hepatology, PLLC Suite 208 2015 Randolph Road Charlotte, NC 28207 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Lawson, Aimee M. Mohanty, Sanjib P. Prendiville, Simon S. Roddey Jr., John Gardiner R. Scholz, David G. Stone, Eric E. Wilson, Jason A.
Hassanein, Tarek (16471)
Southern California Research Center Suite 101 131 Orange Avenue Coronado, CA 92118 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Biando, Karel Fornadel, Andrew Harvey, Samantha T. Hefner, Anna Marie Mendoza, Adriana Meza, Lauren Elizabeth; Reshamwala, Preeti A. Vargas, Chanel
9
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Herring Jr, Robert (16140)
Quality Medical Research, PLLC Suite 103 330 Wallace Road Nashville, TN 37211 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Conway, Edmond T.
Kayali, Zeid (48579)
Inland Empire Liver Foundation Suite A 2006 North Riverside Avenue Rialto, CA 92377 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Amador, Cory Platt, Katrina Pozza, Renee
Kemmer, Nyingi (51036) (Replaced Neff, Guy [48585])
Tampa General Medical Group, Tampa General Hospital 409 Bayshore Boulevard Tampa, FL 33606 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Albers, Christopher Alsina, Angel Cece, Elizabeth Parkinson, Erin Reilly, Michele Zuske, Mirjam
King, William (20765)
Trial Management Associates; LLC 5115 Oleander Drive Wilmington, NC 28403 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Abbott, Flo Marie Carney, David Spencer Gulish, Kristen Henihan, Robert D. Jonathan Klein, Steven Douglas Nichols, Jean Ellen Pennington, Stacey Erin
10
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Lalezari, Jacob (12641)
Quest Clinical Research Suite 202 2300 Sutter Street San Francisco, CA 94115 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
None
Longpre, Daniele (49440)
Clinique Medicale L'Actuel Suite 1130 1001 De Maisonneuve Boulevard East Montreal, QC H2L 4P9 Canada
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Boissonnault, Michel Charest, Louise Huchet, Emmanuelle Lavoie, Stephane Legault, Danielle Murphy, Daniel Poliquin, Marc Thomas, Rejean Trottier, Benoit
Manos, Paul (48582)
eStudySite 3998 Vista Way Suite 102 Oceanside, CA 92056
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Frisbie, John A. Gill, John C. Mannis, Steven Hugh McManus, Alison J. O'Riordan, William D. Thomas, C. Michele Zakko, Maram F.
11
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Mehra, Purvi (48583) (Replaced by Overcash, J. Scott [51382])
eStudySite Suite 300 6367 Alvarado Court San Diego, CA 92120 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Chu, Hanh Korn, Errol R. Lee, Kia Manos, Paul J. McManus, Alison J. O'Riordan, William D. Overcash, J. Scott
Nahass, Ronald (48584)
ID Care of New Jersey Suite 101 105 Raider Boulevard Hillsborough, NJ 08844 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Allegra, Donald T. Herman, David J. McManus, Edward J.
Neff, Guy (48585) (Replaced by Kemmer, Nyingi [51036])
Tampa General Medical Group, Tampa General Hospital 409 Bayshore Boulevard Tampa, FL 33606 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Albers, Christopher Alsina, Angel Cece, Elizabeth Kemmer, Nyingi Parkinson, Erin Reilly, Michele Zuske, Mirjam
Oguchi, Godson (48698)
Midland Florida Clinical Research Center, LLC Suite 1 665 Peachwood Drive DeLand, FL 32720 United States
Central: Quorum Review IRB Suite 800 1501 Fourth Avenue Seattle, WA 98101 United States
Krishnan, Ananth
12
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Osiyemi, Olayemi (37536)
Triple O Research Institute, P.A. Suite 200 1515 North Flagler Drive West Palm Beach, FL 33401 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Kuretski, Jennifer L. Manajovsky, Jose
Overcash, J. Scott (51382) (Replaced Mehra, Purvi [48583]) *Investigator is listed as "Overcash, J." in the clinical database.
eStudySite 752 Medical Center Court Suite 105 Chula Vista, CA 91911 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Chu, Hanh Korn, Errol R. Lee, Kia McManus, Alison J. Mehra, Purvi Kothari
Priest, Matthew (49304)
Gartnavel General Hospital Hepatitis Clinic Level 7B 1053 Great Western Road Glasgow, Scotland, G12 0YN United Kingdom
Central: NRES Committee London - City and East South West REC Centre, Level 3, Block B Whitefriars, Lewins Mead Bristol, BS1 2NT United Kingdom
Bell, David Fox, Raymond Mills, Peter
13
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Ramgopal, Moti (33226)
Midway Immunology and Research Center 356 East Midway Road Fort Pierce, FL 34982 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Collin, Berjan Jacobs, Brenda
Ramji, Alnoor (47486)
GIRI Gastrointestinal Research Institute Suite 770 1190 Hornby Street Vancouver, BC V6Z-2K5 Canada
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Amar, Jack N. Bressler, Brian L. Enns, Robert A. Halparin, Lawrence Ko, Hin Hin Lam, Eric Chon-San Telford, Jennifer Jan Whittaker, J. Scott
Rausher, David (48699) (Site did not enroll)
Atlanta Center for Gastroenterology PC Suite 550 2665 North Decatur Road Decatur, GA 30033 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Parrish, Charles C.
14
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Ravinuthala, Ravi (42812)
Consultants for Clinical Research Suite 730 8271 Cornell Road Cincinnati, OH 45249 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Einwald, Laurie Fry, James R. Hill, Whitney Jonas, Mark Edward Kreines, Michael David Mangels, David Gregory Safdi, Alan Victor South, Christopher D.
Rhame, Frank (6078) *Investigator is listed as "Rhame F" in the clinical database.
Abbott Northwestern Hospital Virginia Piper Cancer Institute Suite 602 800 East 28th Street Minneapolis, MN 55407-3799 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Bormann, Alison
Rodriguez, Jorge (32515)
Orange Coast Medical Group Suite 200 B 510 Superior Avenue Newport Beach, CA 92663 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Camacho Salazar, Laura Mest, Douglas
Ruane, Peter (9818) *Investigator is listed as "Ruane P" in the clinical database.
Peter J. Ruane, MD, Inc. Suite 401 5901 West Olympic Boulevard Los Angeles, CA 90036 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Ain, Dani Wolfe, Peter
15
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Rustgi, Vinod (9174)
Metropolitan Research Suite 209 3301 Woodburn Road Annandale, VA 22003 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Keller, Andrea Lynn Pham, Huong (Jane) T. Rassulova, Svetlana Schultz, Beth M. Yankouskaya, Maria
Ryder, Stephen (42765)
Universiity Hospital Queen's Medical Centre Nottingham Digestive Diseases Centre and Biomedical Research Unit Nottingham University Hospitals NHS Trust Derby Road, Queens Medical Centre Campus Nottingham, NG7 2UH United Kingdom
Central: NRES Committee London - City and East South West REC Centre, Level 3, Block B Whitefriars, Lewins Mead Bristol, BS1 2NT United Kingdom
James, Martim Thomas, James
Saag, Michael S. (8323) *Investigator is listed as "Saag, M" in the clinical database.
University of Alabama at Birmingham Center for AIDS Research, UAB BBRB 256D 845 19th Street South Birmingham, AL 35294 United States
Local: Western Institutional Review Board (WIRB) 3535 Seventh Avenue Southwest Olympia, WA 98502-5010 United States
Alvarez, Alicarmen Dobbs, Gina Franco, Ricardo Johnson, Victoria A. Lindsey, Elizabeth Messer, Michael Mugavero, Michael Overton, Edgar Turner Raper, James
16
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Santoro, John (42368)
AGA Clinical Research Associates, LLC 3205 Fire Road Egg Harbor Township, NJ 08234 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Kaufman, Barry P. Rosman, Gary A. Spaar, Joseph L. Stevens, Theresa M.
Sepe, Thomas (48586)
University Gastroenterology 2nd Floor 33 Staniford Street Providence, RI 02905 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Newton, Eric
Tam, Edward (42420)
LAIR Centre Suite 305 750 West Broadway Vancouver, BC V5Z 1H2 Canada
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
None
Tsai, Naoky (42419)
The Queens Medical Center Liver Center Suite 405 550 S. Beretania Street Honolulu, HI 96813 United States
Local: The Queens Medical Center Institutional and Research Review Committee University Tower #505 1301 Punchbowl Street Honolulu, HI 96813 United States
Hong, Leena Huddleston, Leslie Kuo, Timothy Roytman, Marina Trujillo, Ruby
17
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Wyles, David (47281)
UCSD Antiviral Research Center (AVRC) Suite A 220 Dickinson Street San Diego, CA 92103 United States
Local: University of California San Diego Human Research Protections Program East Campus Office Building (ECOB), First Floor 9444 Medical Center Drive La Jolla, CA 92093 United States
Gish, Robert G Hoffman, Julie Kuo, Alexander Muttera, Leticia Nuffer, Kathleen Pacheco, Dee Dee Santangelo, Joanne Schooley, Robert T
Younes, Ziad (22887)
Gastro One Suite A 1310 Wolf Park Drive Germantown, TN 38138 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Elsakr, Raif W. Jeffreys, Chantil D. Leal, Rolando J. Pop, Anca I.
Younossi, Zobair (45110)
Inova Fairfax Hospital Center for Liver Diseases 3300 Gallows Road Falls Church, VA 22042 United States
Central: Quorum Review IRB Suite 1000 1601 Fifth Avenue Seattle, WA 98101 United States
Afendy, Mariam Y. Cable, Rebecca A. Cooper, James N. Lam, Brian P. Mir, Heshaam Mishra, Alita Nader, Fatema H.
18
ABT-450/r/ABT-267, ABT-333 M14-002 Clinical Study Report – Final R&D/14/1299
List of Investigators and Corresponding IEC/IRB Investigator Name (Investigator Number) Yozviak, Joseph (40604)
Site Name/Post Office Address
Name and Address of IEC/IRB
Subinvestigators
Lehigh Valley Health Network/Lehigh Valley Hospital Lehigh Valley Hospital 1210 Building, Suite 1000 Cedar Crest Boulevard & I-78 Allentown, PA 18103 United States
Local: Lehigh Valley Health Network/Lehigh Valley Hospital Institutional Review Board Research Participant Protection Office, Suite 3500 1255 South Cedar Crest Boulevard Allentown, PA 18103 United States
Beitler, Cynthia E. Centolanza, Lauri L. Friel, Timothy Gareca, Marcelo Hoffman-Terry, Margaret Marsh, Hugh A.
19
