Study to Investigate GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant

Status:	Completed
Conditions:	Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	3/30/2013
Start Date:	September 2012
End Date:	October 2014
Contact:	JoAnn Dyangko, BS
Email:	JoAnn.Dyangko@gilead.com
Phone:	650-574-3000

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 Hepatitis C Virus(HCV) Post Liver Transplant

This is an open-label, single-arm study of GS-7977 and ribavirin (RBV) in subjects 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.

Inclusion Criteria:

- 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

- Naïve to all nucleotides/nucleoside treatments for chronic HCV infection

Exclusion Criteria:

- Multi-organ 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 human immunodeficiency virus (HIV) at
screening

- Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy,
hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated
cirrhosis

We found this trial at

sites

Clinical Trial Facility in Indianapolis Indiana

Indianapolis, Indiana 46202

from

Indianapolis, IN