Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response \[SVR\]) versus risk (safety and resistance).

Key facts

Study ID

NCT01435044

Run by

Gilead Sciences

People needed

239

Starts

2011-09-01

Expected to finish

2013-05-01

Last updated by the study team

2014-02-06

Who can join

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

You may qualify if…

• Chronic HCV-infection
• Naive to all HCV antiviral treatment
• Otherwise healthy patients

You may not qualify if…

• Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
• History of any other clinically significant chronic liver disease
• Medical history which the investigator considers the patient unsuitable for the study

Where it is running

• Alabama Liver & Digestive Specialists — Montgomery, Alabama, United States
• Study site — Bakersfield, California, United States
• Study site — Coronado, California, United States
• Study site — La Mesa, California, United States
• Study site — 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
• Study site — Denver, Colorado, United States
• Study site — Engelwood, Colorado, United States
• South Denver Gastroenterology — Englewood, Colorado, United States
• Study site — 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
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States

Full record on ClinicalTrials.gov

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