Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.

Key facts

Study ID

NCT01329978

Run by

Gilead Sciences

People needed

332

Starts

2011-03-01

Expected to finish

2012-08-01

Last updated by the study team

2014-05-26

Who can join

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

You may qualify if…

• Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate
• Naive to previous HCV treatment

You may not qualify if…

• Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
• History of any other clinically significant chronic liver disease

Where it is running

• Alabama Liver and Digestive Specialist — Montgomery, Alabama, United States
• Clopton Clinic — Jonesboro, Arkansas, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Providence Clinical Research — Burbank, California, United States
• Southern California Liver Centers — Coronado, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• eStudy Site — Oceanside, California, United States
• Desta Digestive Disease Medical Center — San Diego, California, United States
• Medical Associates Reseach Group — San Diego, California, United States
• Kaiser Permanente Hepatology Research — San Diego, California, United States
• University of Colorado Denver Transplant Center and Hepatology Clinic — Aurora, Colorado, United States
• South Denver Gastreoenterology — Englewood, Colorado, United States
• Pointe West Infectious Disease — Bradenton, Florida, United States
• Avail Clinical Research — DeLand, Florida, United States
• University of Florida College of Medicine — Gainesville, 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
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Investigative Clinical Research — Annapolis, Maryland, United States
• Clinical Associates Research — Reisterstown, Maryland, United States
• Beth Israel Deconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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