278
Participants
Start Date
March 31, 2012
Primary Completion Date
November 30, 2012
Study Completion Date
February 28, 2013
SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Placebo to match SOF
Placebo to match SOF was administered orally once daily.
Placebo to match RBV
Placebo to match RBV was administered orally twice daily.
Auckland Clinical Studies Limited, Auckland
Westmead Hospital, Westmead
St. Vincent's Hospital, Melbourne
Monash Medical Centre, Melbourne
Royal Brisbane & Women's Hospital, Herston
Christchurch Hospital, Christchurch
Weill Cornell Medical College, New York
Mount Sinai School of Medicine, New York
Binghamton Gastroenterology Associates, Binghamton
University of Pennsylvania, Philadelphia
Whitman Walker Clinic, Washington D.C.
Johns Hopkins University, Lutherville
Metropolitan Research, Fairfax
Inova Fairfax Hospital Center for Liver Diseases, Falls Church
Digestive and Liver Disease Specialists, Norfolk
Liver Institute of Virginia, Bon Secours St.Mary's, Newport News
Digestive Health Specialists, PA, Winston-Salem
Duke University, Durham
Gastrointestinal Specialists of Georgia, PC, Marietta
Digestive Healthcare of Georgia, Atlanta
Borland-Groover Clinic, Jacksonville
Internal Medicine Specialists, Orlando
University of Miami, Center for Liver Diseases, Miami
South Florida Center of Gastroenterology, P.A., Wellington
Advanced Research Institute, New Port Richey
Nashville Gastrointestinal Specialists, Inc, Nashville
Gastro One, Germantown
Graves-Gilbert Clinic, Bowling Green
Indianapolis Gastroenterology Research Foundation, Indianapolis
Henry Ford Health System, Novi
Minnesota Gastroenterology, P.A., Saint Paul
Kansas City Gastroenterology and Hepatology, Kansas City
Gastroenterology Associates, LLC, Baton Rouge
Southwest Infectious Disease Clinical Research, Inc., Dallas
Therapeutic Concepts, PA, Houston
Alamo Medical Research, San Antonio
University of Colorado, Aurora
South Denver Gastroenterology, Englewood
Kaiser Permanente, Los Angeles
Lightspeed Medical, Los Angeles
Anthony Mills MD, Inc., Los Angeles
UCSD Antiviral Research Center, San Diego
SCTI Research Foundation Liver Center, Coronado
Kaiser Permanente, San Diego
Quest Clinical Research, San Francisco
Virginia Mason Medical Center, Seattle
Medical Associates Research Group, San Diego
University of Alabama Birmingham, Birmingham
University of Florida, Gainesville
Orlando Immunology Center (ACH), Orlando
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center, Boston
The Research Institute, Springfield
Comprehensive Clinical Research, Berlin
ID Care, Hillsborough
University Gastroenterology, Providence
University of Calgary, Calgary
Gordon & Leslie Diamond Health Care Centre, Vancouver
(G.I.R.I.) Gastrointestinal Research Institute, Vancouver
Toronto Liver Centre, Toronto
CHUM - The Research Centre, Montreal
Fundacion De Investigacion De Diego, San Juan
Clinical Research Puerto Rico Inc, San Juan
Lead Sponsor
Gilead Sciences
INDUSTRY