DEB025 in chronic hepatitis C G1 previous treatment non-responders
Research type
Research Study
Full title
A multicentre, randomized, double-blind, placebo controlled, parallel-group phase II study on the efficacy and safety of DEB025 combined with peg-IFN alfa-2a and ribavirin in chronic hepatitis C genotype 1 patients who are previous peg-IFN alfa-2 plus ribavirin treatment-non-responders
IRAS ID
54406
Contact name
Scholtz Marius
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2010-020033-14
ISRCTN Number
n/a
Research summary
The standard treatment for patients with chronic hepatitis C (HCV) genotype 1 (GT1) who are treatment-naÇîve is 48 weeks of therapy with a pegylated interferon (PEG IFN) plus ribavirin.More than one third of these patients treated with PEG IFN and ribavirin are reported to be unable to clear the virus from the serum. For HCV GT1 patients who were non-responders to the standard of care (SOC) treatment, re-treatment with the same combination of PEG IFN and ribavirin is expected to result in less than 5% of patientsachieving a sustained response and is not recommended by current treatment guidelines (Ghany et al, 2009).DEB025 (alisporivir) is an orally available cyclophilin inhibitor that has shown potent anti-hepatitis C virus (HCV) activity in clinical studies with additive clinical effect when combined with PEG IFN and ribavirin.This study is a phase II study comparing triple therapy with 2 doses of DEB025 (600mg or 800mg) plus standard of care therapy (PEG IFN and ribavirin) against triple therapy placebo plus standard of care therapy (PEG IFN and ribavirin).The study is in approximately 258 treatment-experienced HCV genotype 1 patients who are non-responders to previous SOC therapy. The study will include 16 patientsacross 4 sites in the UK.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
10/H0504/47
Date of REC Opinion
3 Sep 2010
REC opinion
Further Information Favourable Opinion