Phase 2 study in participants with Hepatitis C and liver transplant
Research type
Research Study
Full title
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects with Chronic HCV Infection who have Received a Liver Transplant
IRAS ID
206050
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-000416-15
Duration of Study in the UK
0 years, 9 months, 26 days
Research summary
Hepatitis C virus (HCV) infection is a global health challenge with an estimated 150 million individuals infected worldwide. Chronic HCV infection remains a leading cause of chronic hepatitis, cirrhosis, and liver cancer and a primary indication for liver transplantation in the Western world. In the United States, between 1995 and 2010 there were 52,000 HCV-associated liver transplants. These patients universally experience post-operative recurrence of HCV, and are particularly vulnerable to complications associated with HCV recurrence including cirrhosis, fibrosing cholestatic hepatitis, graft loss, liver re-transplantation, and death. Therefore treating HCV recurrence is of great importance to patients who have undergone liver transplant.
The study aims to enroll approximately 80 participants over 18 years old, male or non-pregnant/non-lactating female with chronic hepatitis C virus (HCV) infection who have received a liver transplant will be enrolled and treated with the study medication, Sofosbuvir/Velpatasvir Fixed Dose Combination (SOF/VEL FDC) tablet once daily for 12 weeks.
All participants will complete the following study visits: Screening, Baseline/Day 1, on-treatment visits at the end of Weeks 2, 4, 8, and 12, and post-treatment visits at Weeks 4 and 12 after completion of study treatment.
Taking part in this study will last about 6 months, not including the screening visit. During this time, the participants will be required to visit the hospital at a maximum of 8 times.The SOF/VEL FDC (400/100 mg) is a co-formulation of SOF 400 mg and VEL 100 mg which is currently being developed as a treatment for HCV through several completed and several ongoing phase 3 trials.
The development of SOF/VEL may have a major impact on the global prevalence and burden of HCV as it may represent a simple, well tolerated, highly efficacious pan-genotypic (effective across different types of HCV) treatment for all HCV infected patients.
The study will take place at approximately 18 centres in the UK, Spain and Switzerland.
REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/1008
Date of REC Opinion
14 Jul 2016
REC opinion
Further Information Favourable Opinion