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

Completed · Phase 2

Conditions studied: Recurrent Chronic Hepatitis C Virus, Post Liver Transplant

In brief

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.

Key facts

Study ID

NCT01687270

Run by

Gilead Sciences

People needed

40

Starts

2012-11-01

Expected to finish

2014-08-01

Last updated by the study team

2014-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation
• HCV RNA ≥ 10,000 IU/mL at screening
• Absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to baseline/Day 1 visit
• Liver transplant ≥ 6 months and ≤ 12 years prior to screening
• Naive to all nucleotide/nucleoside treatments for chronic HCV infection

You may not qualify if…

• Multiorgan transplant that includes heart or lung recipient
• Subjects with de novo or recurrent Hepatocellular Carcinoma(HCC) post transplant
• Current use of corticosteroids at any dose > 5mg of prednisone/day (or equivalent dose of corticosteroid)
• Infection with hepatitis B virus (HBV) or HIV at screening
• Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis

Where it is running

• Study site — San Francisco, California, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Kansas City, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Villejuif, France
• Study site — Hanover, Lower Saxony, Germany
• Study site — Grafton, Auckland, New Zealand
• Study site — Barcelona, Barcelona, Spain

Full record on ClinicalTrials.gov

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