NCT01687270

Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Recurrent Chronic Hepatitis C Virus
• Post Liver Transplant

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir 400 mg tablet administered orally once daily
DRUG	RBV	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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-12-01
• Completion: 2014-08-01
• First posted: 2012-09-18
• Last updated: 2014-12-19
• Results posted: 2014-12-19

Locations

12 sites across 5 countries: United States, France, Germany, New Zealand, Spain