Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

Completed · Phase 3

Conditions studied: Chronic Hepatitis C

In brief

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

Key facts

Study ID

NCT01625338

Run by

Gilead Sciences

People needed

534

Starts

2012-06-01

Expected to finish

2014-12-01

Last updated by the study team

2015-11-09

Who can join

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

You may qualify if…

• Infection with HCV
• Must have participated in a prior Gilead HCV study
• Use of highly effective contraception methods if female of childbearing potential or sexually active male
• Eligible patients include those in the following
• received placebo or Peg-IFN+RBV in a control arm
• previously participated in a Gilead-sponsored HCV study and did not attain sustained virologic response 24 weeks after discontinuation of therapy (SVR24) on a regimen containing:
• Sofosbuvir+RBV
• Peg-IFN and/or RBV in combination with one or more Gilead investigational direct-acting agents

You may not qualify if…

• Pregnant or nursing female or male with pregnant female partner
• Current or prior history of clinical hepatic decompensation
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Chronic use of systemically administered immunosuppressive agents
• Active drug abuse
• Use of any prohibited concomitant medications

Where it is running

• Franco Felizarta, MD — Bakersfield, California, United States
• Arrowhead Regional Medical Center — Colton, California, United States
• Southern California Transplantation Institute, Research Foundation Liver Center — Coronado, California, United States
• eStudy Site — La Mesa, California, United States
• Kaiser Permanente — Los Angeles, California, United States
• Lightsource Medical/Peter J. Ruane MD, Inc. — Los Angeles, California, United States
• California Liver Institute — Los Angeles, California, United States
• Anthony Mills MD, Inc. — Los Angeles, California, United States
• eStudySite — Oceanside, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• University of California — San Diego, California, United States
• Resarch and Education, Inc. — San Diego, California, United States
• Medical Associates Research Group — San Diego, California, United States
• Kaiser Permanente — San Diego, California, United States
• Quest Clinical Research — San Francisco, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• South Denver Gastroenterology, PC — Englewood, Colorado, United States
• Whitman-Walker Health — Washington D.C., District of Columbia, United States
• Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases — Bradenton, Florida, 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
• Orlando Immunology Center — Orlando, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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