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Research type
Research Study
Full title
A phase II, open-label, single arm, multicentre, international trial of sofosbuvir and GS-5816 for people with chronic hepatitis C virus infection and recent injection drug use
IRAS ID
172592
Contact name
John Dillon
Contact email
Sponsor organisation
University of New South Wales
Eudract number
2015-000178-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, days
Research summary
The purpose of this study to evaluate how effective, safe and tolerable SOF/GS-5816 is when taken for 12 weeks by people infected with HCV and who are recent injection drug users. For the purpose of this study anyone who has injected drugs in the previous 24 weeks is considered to be a recent injection drug user.
The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment. The study will also look at whether people get reinfected with HCV and is so, why.
REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/0025
Date of REC Opinion
28 Apr 2016
REC opinion
Further Information Favourable Opinion