Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
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|ClinicalTrials.gov Identifier: NCT01687270|
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Chronic Hepatitis C Virus Post Liver Transplant||Drug: Sofosbuvir Drug: RBV||Phase 2|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||August 2014|
Participants will receive sofosbuvir+RBV for 24 weeks.
Sofosbuvir 400 mg tablet administered orally once daily
Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.
Other Name: Ribasphere®
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
- Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event [ Time Frame: Baseline to Week 24 ]
- Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48) [ Time Frame: Posttreatment Weeks 4, 24, and 48 ]SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.
- Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24 [ Time Frame: Weeks 12 and 24 ]
- HCV RNA and Change From Baseline at Weeks 2, 4, and 8 [ Time Frame: Baseline; Weeks 2, 4, and 8 ]
- Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
Virologic failure was defined as on-treatment virologic failure or virologic relapse.
- On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment
- Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 10016|
|New York, New York, United States, 10032|
|Hannover, Lower Saxony, Germany|
|Grafton, Auckland, New Zealand|
|Study Director:||Jill M. Denning, MA||Gilead Sciences|