Safety of Efficacy of Sofosbuvir (GS-7977) and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.
Recurrent Chronic Hepatitis C Virus
Post Liver Transplant
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|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant|
- Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
- Proportion of participants who discontinue study drug due to an adverse event [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
- Proportion of participants with sustained virologic response (SVR) at 4, 24, and 48 weeks after discontinuation of therapy (SVR2, SVR4, SVR8, and SVR24) [ Time Frame: Posttreatment Weeks 4, 24, and 48 ] [ Designated as safety issue: No ]
- Proportion of participants who have HCV RNA < LLOQ by visit while on treatment [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
- Absolute and change from baseline in HCV RNA through Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
- Proportion of participants with virologic failure [ Time Frame: Baseline to posttreatment Week 48 ] [ Designated as safety issue: No ]Virologic failure is defined as virologic breakthrough (participant achieved undetectable HCV RNA levels during treatment but subsequently had detectable HCV RNA while continuing treatment), non-response (HCV RNA ≥ LLOQ through 24 weeks of treatment), or relapse (participant achieved undetectable HCV RNA levels during treatment maintained undetectable HCV RNA for the duration of treatment or achieved undetectable HCV RNA within 4 weeks of the end of treatment but did not achieve SVR at 4, 24, and 48 weeks posttreatment).
|Study Start Date:||November 2012|
|Study Completion Date:||August 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Participants will receive sofosbuvir+RBV for 24 weeks.
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:Drug: RBV
Ribavirin (RBV) 200-mg tablet(s) administered orally in two divided daily doses. RBV dosing (200-1200) will be determined and adjusted according to participants' hemoglobin value, creatinine clearance, and weight.
Other Name: Ribasphere®
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687270
|United States, California|
|San Francisco, California, United States|
|United States, Indiana|
|Indianapolis, Indiana, United States|
|United States, Kansas|
|Kansas City, Kansas, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|United States, Michigan|
|Ann Arbor, Michigan, United States|
|United States, Minnesota|
|Rochester, Minnesota, United States|
|United States, New York|
|New York, New York, United States, 10032|
|New York, New York, United States, 10016|
|Hannover, Lower Saxony, Germany|
|Grafton, Auckland, New Zealand|
|Study Director:||Jill M. Denning, MA||Gilead Sciences|