Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Hepatitis C

In brief

This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.

Key facts

Study ID

NCT01542788

Run by

Gilead Sciences

People needed

278

Starts

2012-03-01

Expected to finish

2013-02-01

Last updated by the study team

2014-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infection with HCV genotype 2 or 3
• Cirrhosis determination
• Subject meets one of the following classifications:
• IFN unwilling
• IFN ineligible
• IFN intolerant
• Screening laboratory values within defined thresholds
• Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
• Use of highly effective contraception methods if female of childbearing potential or sexually active male

You may not qualify if…

• Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
• Pregnant or nursing female or male with pregnant female partner
• Current or prior history of clinical hepatic decompensation
• History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
• Excessive alcohol ingestion or significant drug abuse

Where it is running

• SCTI Research Foundation Liver Center — Coronado, California, United States
• Kaiser Permanente — Los Angeles, California, United States
• Lightspeed Medical — Los Angeles, California, United States
• Anthony Mills MD, Inc. — Los Angeles, California, United States
• Medical Associates Research Group — San Diego, California, United States
• UCSD Antiviral Research Center — San Diego, California, United States
• Kaiser Permanente — San Diego, California, United States
• Quest Clinical Research — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• South Denver Gastroenterology — Englewood, Colorado, United States
• Whitman Walker Clinic — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• University of Miami, Center for Liver Diseases — Miami, Florida, United States
• Advanced Research Institute — New Port Richey, Florida, United States
• Orlando Immunology Center (ACH) — Orlando, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• South Florida Center of Gastroenterology, P.A. — Wellington, Florida, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Indianapolis Gastroenterology Research Foundation — Indianapolis, Indiana, United States
• Graves-Gilbert Clinic — Bowling Green, Kentucky, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• Johns Hopkins University — Lutherville, Maryland, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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