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
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2012 |
| End Date: | December 2014 |
An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
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).
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).
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
68
sites
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Bradenton, Florida 34209
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Coronado, California 92118
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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2315 Stockton Blvd.
Sacramento, California 95817
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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