Phase 3 Study of Sofosbuvir and Ribavirin

Completed · Phase 3

Conditions studied: Hepatitis C

In brief

This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

Key facts

Study ID

NCT01497366

Run by

Gilead Sciences

People needed

527

Starts

2011-12-01

Expected to finish

2013-04-01

Last updated by the study team

2014-04-02

Who can join

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

You may qualify if…

• Chronic Genotype 2 or 3 HCV-infection
• Naive to all HCV antiviral treatment(s)

You may not qualify if…

• Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab
• History of any other clinically significant chronic liver disease
• A history consistent with decompensated liver disease
• History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
• Participation in a clinical study within 3 months prior to first dose

Where it is running

• Alabama Liver & Digestive Specialist — Montgomery, Alabama, United States
• Franco Felizarta, MD — Bakersfield, California, United States
• California Liver Institute — Beverly Hills, California, United States
• Arrowhead Regional Medical Center — Colton, California, United States
• SCTI Research Foundation — Coronado, California, United States
• eStudy Site — La Mesa, California, United States
• Peter J. Ruane, M.D. Inc. — Los Angeles, California, United States
• eStudySite — Oceanside, California, United States
• University of California, Davis - Health System — Sacramento, California, United States
• University of California San Diego Medical Center — San Diego, California, United States
• Research and Education, Inc. — San Diego, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• Quest Clinical Research — San Francisco, California, United States
• South Denver Gastroenterology, PC — Englewood, Colorado, United States
• Pointe West Infectious Diseases — Bradenton, Florida, United States
• Midway Immunology & Research Center, LLC — Ft. Pierce, Florida, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Borland-Groover Clinic Baptist — Jacksonville, Florida, United States
• University of Miami, School of Medicine — Miami, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• Advanced Research Institute — Trinity, Florida, United States
• South Florida Center of Gastroenterology — Wellington, Florida, United States
• AIDS Research Consortium of Atlanta, Inc. — Atlanta, Georgia, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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