Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
NCT ID: NCT01435044
Last Updated: 2014-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
239 participants
INTERVENTIONAL
2011-09-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SOF+RBV 12 Weeks
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks.
Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
SOF+RBV 24 Weeks
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks.
Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
GS-0938 Alone
Participants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks.
GS-0938
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
Placebo to match sofosbuvir
Placebo to match sofosbuvir administered orally once daily
GS-0938+SOF
Participants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks.
Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
GS-0938
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
GS-0938+SOF+RBV
Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks.
Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
GS-0938
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Placebo
Deferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks.
Placebo to match sofosbuvir
Placebo to match sofosbuvir administered orally once daily
Placebo to match GS-0938
Placebo to match GS-0938 administered orally once daily
Retreatment Group - SOF+RBV 24 Weeks
After discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks.
Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Interventions
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Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
GS-0938
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Placebo to match sofosbuvir
Placebo to match sofosbuvir administered orally once daily
Placebo to match GS-0938
Placebo to match GS-0938 administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naive to all HCV antiviral treatment
* Otherwise healthy patients
Exclusion Criteria
* History of any other clinically significant chronic liver disease
* Medical history which the investigator considers the patient unsuitable for the study
18 Years
ALL
No
Sponsors
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Quintiles, Inc.
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Robert H. Hyland, DPhil
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Alabama Liver & Digestive Specialists
Montgomery, Alabama, United States
Bakersfield, California, United States
Coronado, California, United States
La Mesa, California, United States
Los Angeles, California, United States
CLI
Los Angeles, California, United States
UCSD Antiviral Research Center
San Diego, California, United States
eStudy Site
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
Denver, Colorado, United States
Engelwood, Colorado, United States
South Denver Gastroenterology
Englewood, Colorado, United States
Washington D.C., District of Columbia, United States
Avail Clinical Research
DeLand, Florida, United States
University of Florida Hepatology
Gainesville, Florida, United States
University of Miami Center for Liver Diseases
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Advanced Research Institute
Trinity, Florida, United States
South Florida Center of Gastroenterology
Wellington, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Digestive Health Services
Downers Grove, Illinois, United States
Investigative Clinical Research
Annapolis, Maryland, United States
Baltimore, Maryland, United States
ID Care
Hillsborough, New Jersey, United States
Concorde Medical Group
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Ashville Gastroenterology Associates
Ashville, North Carolina, United States
Carolina's Center for Liver Disease
Statesville, North Carolina, United States
Digestive Health Specialists
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Gastro One
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists
Nashville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Central Texas Clinical Research
Austin, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
San Juan, Puerto Rico, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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Other Identifiers
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P2938-0721
Identifier Type: -
Identifier Source: org_study_id
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