324
Participants
Start Date
October 31, 2010
Primary Completion Date
January 31, 2013
Study Completion Date
September 30, 2013
GS-9190
GS-9190 capsule, 20 mg BID, 16 or 24 weeks
GS-9256
GS-9256 capsule, 150 mg BID, 16 or 24 weeks
Pegasys®
peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks
Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks
GS-9190 placebo
placebo matching GS-9190 capsule BID, 24 weeks
GS-9256
GS-9256 capsule, 150 mg BID, 24 weeks
Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks
Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks
GS-9190 placebo
placebo matching GS-9190 capsule BID, 24 weeks
GS-9256 placebo
placebo matching GS-9256 capsule BID, 24 weeks
Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks
Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), 48 weeks
ULB Erasme, Brussels
AKH der Stadt Wien, Vienna
Wilhelminenspital der Stadt Wien, Vienna
UCL Saint Luc, Brussels
SGS - Clinical Pharmacology Unit Antwerpen, Antwerp
UZ Antwerp, Edegem
CHU Sart Tilman, Liège
Krankenhaus der Elisabethinen Linz GmbH, Linz
LKH Innsbruck, Innsbruck
Medizinische Universität Graz, Graz
Concorde Medical Group, New York
Cornell University Gastroenterology & Hepatology, New York
Mount Sinai Medical Center, New York
Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista, Torino
North Shore University Hospital, Great Neck
Saint Joseph Hospital, Marseille
Charite University Medicine, Berlin
Hospital Clínico Universitario San Cecilio, Granada
Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH, Hamburg
U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan
Johns Hopkins University, Lutherville
Metropolitan Research, Fairfax
Digestive and Liver Disease Specialists, Norfolk
Liver Institute of Virginia, Bon Secours, Newport News
"Epatologia, Azienda Ospedaliero Spedali Civili", Brescia
Duke University Medical Center, Durham
Hospital Universitario Ramón y Cajal, Madrid
Hospital Universitario Puerta de Hierro Majadahonda, Madrid
Atlanta Gastroenterology Associates, Atlanta
Emory University, Infectious Disease Clinic, Atlanta
Medizinische Hochschule Hannover, Hanover
University of Florida, Gainesville
Orlando Immunology Center, Orlando
University of Miami Center for Liver Diseases, Miami
Bach and Godofsky Infectious Diseases, Sarasota
Medicina Generale - Azienda Ospedaliera di Padova, Padua
Memphis Gastroenterology Group, Germantown
UT Southwestern Medical Center at Dallas, Dallas
Hospital Universitario Ntra. Sra. de Valme, Seville
Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria, Parma
University Hospitals Case Medical Center, Cleveland
University Hospital Essen, Essen
Hospital General Universitario de Valencia, Valencia
Indiana University, Indianapolis
Henry Ford Health System, Detroit
University Hospital Bonn, Bonn
Nancy University Hospital Center, Vandœuvre-lès-Nancy
Johannes Gutenberg University Hospital, Mainz
Claude Huriez Hospital, Lille
Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt/M
Northwestern Memorial Hospital, Chicago
Hotel Dieu Hospital, Lyon
University hospital Heidelberg, Heidelberg
Gastroenterology Associates, LLC, Baton Rouge
The North Texas Research Institute, Arlington
Alamo Medical Research, San Antonio
University Hospital Freiburg, Freiburg im Breisgau
South Denver Gastroenterology, Englewood
Ludwig-Maximilians-University Munich, München
Mayo Clinic, Phoenix
Southwest CARE Center, Santa Fe
Cedars-Sinai Medical Center, Los Angeles
U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone, Palermo
Scripps Clinic, La Jolla
Beaujon Hospital, Clichy
Medical Associates Research Group, San Diego
Kaiser Permanente, San Diego
Advanced Clinical Research Institute, Anaheim
Henri Mondor Hospital, Créteil
California Pacific Medical Center, San Francisco
Virginia Mason Medical Center, Digestive Disease Institute, Seattle
Beth Israel Deaconess Medical Center, Boston
University Gastroenterology, Providence
Heritage Medical Research Clinic, Calgary
University of Alberta, Division of Gastroenterology, Edmonton
Downtown ID Clinic, Vancouver
Gordon & Leslie Diamond Health Care Centre, Vancouver
GI Research Institute, Vancouver
John Buhler Research Centre, Winnipeg
London Health Sciences Centre, London
Ottawa Hospital, Division of Infectious Diseases, Ottawa
Toronto General Hospital, Toronto
Toronto Western Hospital, Toronto
University Hospital Brno, Brno
Melnik Hospital, Mělník
University Hospital Plzen, Pilsen
Klinmed, s.r.o., Prague
Institute of Clinic and Experimental Medicine, Prague
Association of Physicians for Infection Diseases, Ústí nad Labem
University Hospital Leipzig, Leipzig
Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny, Bialystok
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny, Bydgoszcz
Szpital Specjalistyczny w Chorzowie, Chorzów
"Niepubliczny Zaklad Opieki Zdrowotnej Pol-SaNa-Med Spolka z ograniczona odpowiedzialnoscia", Czeladź
Wojewodzki Szpital Zespolony w Kielcach, Kielce
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Krakow
Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi, Lodz
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin
Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby, Radom
Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie, Szczecin
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny, Warsaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X, Warsaw
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Warsaw
EMC Instytut Medyczny S.A., Wroclaw
Hospital Universitari Vall d'Hebrón, Barcelona
Queen Elizabeth Hospital, Birmingham
North Manchester General Hospital, Greater Manchester
Royal Liverpool University Hospital, Liverpool
Barts and The London Hospital, London
University College London Hospital, London
Kings College Hospital, London
Chelsea and Westminster Hospital, London
Institute of Cellular Medicine (Hepatology), Newcastle upon Tyne
Derriford Hospital, Plymouth
Lead Sponsor
Gilead Sciences
INDUSTRY