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
- Conditions
- liver diseaseliver inflammation1001965410047438
- Registration Number
- NL-OMON39611
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Subjects must meet the following eligibility criteria:
* Chronic HCV
* Subject must have participated in a prior Gilead HCV studie
* Eligibility for this study will be defined in the prior (parent) study with respect to prior treatment assignment, treatment outcome and completion of scheduled assessments. At a minimum, a subject must have completed all screening assessments and met all eligibility criteria in the parent study.
* If eligibility is not defined in the parent study, eligibility can be determined by the Medical Monitor on a case-by-case basis. The Medical Monitor will take into consideration the prior treatment assignment, treatment outcome and completion of scheduled assessments in the parent study.
* Agree to use two forms of contraception for the duration of the study and for 6 months after the last dose of study medication. Females of childbearing potential must have a negative pregnancy test at Screening and Baseline/Day 1
Subjects will be ineligible if they meet any of the following criteria:
* Pregnant or nursing female or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day)
* Active substance abuse which, in the opinion of the investigator, would make the candidate inappropriate for participation in this study.
* Use of any prohibited concomitant medications within 28 days of the Baseline/Day 1 visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is SVR12 (HCV RNA <LLOQ 12 weeks after<br /><br>discontinuation of therapy) in the Full Analysis Set (FAS) population.<br /><br><br /><br>The primary safety endpoint is any AE leading to permanent discontinuation of<br /><br>study drug(s).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy endpoints include the proportion of subjects with: HCV RNA <<br /><br>LLOQ at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24); on<br /><br>treatment virologic failure; and relapse.</p><br>