CDEB025A2301 DEB025 in treatment naive, genotype1 Hepatitis C patients
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled trial of the efficacy and safety of DEB025/Alisporivir in combination with standard of care in hepatitis C genotype 1 treatment-naïve patients
IRAS ID
77854
Contact name
Raj Hanvesakul
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2010-022867-37
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
The aim of this study to evaluate the beneficial effects of DEB025 in combination with pegulated-interferon alpha-2a (Peg-IFNa2a) and ribavirin (RBV) in the treatment of patients with chronic genotype 1 hepatitis C. The study will also see if it is possible to successfully treat patients for a shorter duration of 24 weeks, compared to the current standard of 48 weeks. Currently, with the standard of care treatment (SOC) of Peg-IFNa2a and RBV for treatment naive patients (those not previously exposed to anti-hepatitis treatment) with chronic genotype 1 Hepatitis, only 40-50% treated achieve a sustained clearance of virus for 24 weeks after the end of treatment. DEB025 (alisporivir) is an orally available cyclophilin inhibitor that has shown strong anti-Hepatitis C virus activity in clinical studies, used on its own and also in combination with SOC. The study is a 72 week, phase III study comparing triple therapy with 2 doses of DEB025 (400mg or 600mg) plus SOC against triple therapy placebo plus SOC in 4 treatment arms. In addition, 2 of the treatment arms will be ??Response-guided??. This will mean patients with eligible hepatitis virus levels at week 4 will have 24 weeks of treatment instead of the current standard of 48 weeks. The study will include 1040 patients worldwide, of which 25 will be recruited across 6 sites in the UK.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
11/SC/0255
Date of REC Opinion
22 Jun 2011
REC opinion
Further Information Favourable Opinion