Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant

• Status: Completed
• Trial end date: 2017-07-28
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir

Criteria

Key Inclusion Criteria:

• History of chronic HCV infection (≥ 6 months)

• HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate

• Liver transplant ≥ 3 months prior to screening

• Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis

Key Exclusion Criteria:

• History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,

• Co-infection with HIV or hepatitis B virus

• Known hypersensitivity to study medication,

• Use of any prohibited concomitant medications as within with window before the Day 1 visit.

• De novo or recurrent hepatocellular carcinoma posttransplant

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.