Phase 2 - SOF/VEL in Chronic HCV on Dialysis for Renal Disease
Research type
Research Study
Full title
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects with Chronic HCV Infection Who are on Dialysis for End Stage Renal Disease
IRAS ID
219229
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-003625-42
Duration of Study in the UK
1 years, 4 months, 15 days
Research summary
This study is a Phase 2, open label multicentre study evaluating the efficacy and safety of treatment of Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) a fixed-dosed combination tablet, in patients with chronic HCV infection who are on dialysis for end stage renal disease (ESRD).
Hepatitis C is a disease caused by a virus (known as HCV) which has infected the liver. A virus is a very small organism that invades healthy cells and forces them to make copies of the virus. The body tries to fight the virus, but it can resist the body’s defenses. Some people can clear the virus on their own, but in others the virus cannot be cleared. Those people have chronic or long-term HCV infections. Curing HCV infection is associated with numerous health benefits including more than 70% and 90% reductions in the risk of liver cancer and liver-related mortality respectively.
Epclusa® is already approved in the US, EU and other regions for the treatments of chronic HCV infections, but there is no dosing recommendation for those with severe renal impairment such as ESRD. The unmet medical need provides a strong rationale for this study as the data obtained will address gaps in knowledge.
The purpose of this study is therefore to assess the safety and efficacy of Epclusa® given once daily for 12 weeks in participants with chronic HCV infection who are on dialysis for EDSR. The study aims to enroll approximately 100 male and female participants over the age of 18 at approximately 35 sites in Australia, Canada, New Zealand, Spain, Israel and the United Kingdom. Participants will be enrolled for around 9 months with at least 9 clinic visits falling during and after the treatment periods. Participants will also have the option to partake in future pharmacokinetic and genomic research related to chromic HCV infection.
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/0089
Date of REC Opinion
24 Mar 2017
REC opinion
Further Information Favourable Opinion