Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Hepatitis C

In brief

This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Key facts

Study ID

NCT01604850

Run by

Gilead Sciences

People needed

202

Starts

2012-06-01

Expected to finish

2013-05-01

Last updated by the study team

2014-05-28

Who can join

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

You may qualify if…

• Infection with HCV genotype 2 or 3
• Had cirrhosis determination
• Prior treatment failure
• Screening laboratory values within defined thresholds
• Subject had 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 have interfered with subject treatment, assessment or compliance with the protocol
• Excessive alcohol ingestion or significant drug abuse

Where it is running

• Kaiser Permanente — Los Angeles, California, United States
• Peter J. Ruane, MD, Inc. — Los Angeles, California, United States
• Anthony Mills MD, Inc. — Los Angeles, California, United States
• UCSD Antiviral Research Center — San Diego, California, United States
• Medical Associates Research Group, Inc. — 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, PC — 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 Baptist — Jacksonville, Florida, United States
• University of Miami — 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
• Massachusetts General Hospital — Boston, Massachusetts, United States
• SCTI Research Foundation — Coronado, California, United States

Full record on ClinicalTrials.gov

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