Study of BMS-650032 + pegIFN + RBV for hepatitis C genotypes 1&4 (V1)
Research type
Research Study
Full title
A Phase 2a/2b study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects with Genotypes 1 and 4 Chronic Hepatitis C Infection. Revised Protocol 01, incorporating Protocol Amendment 03 (v1.0, dated 15-Feb-2010) and Pharmacogenetics Blood Sample Protocol Amendment 01 (v2.0, Dated 12-Nov-2009)
IRAS ID
31325
Contact name
Ashley Brown
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2009-013652-69
Clinicaltrials.gov Identifier
Research summary
Treatment options for patients with chronic hepatitis C virus infection (HCV) are limited. Standard treatment is the combination of pegylated interferon alpha and ribavirin. These drugs have to be taken for many weeks and have limited effectiveness for patients with genotype 1 HCV. The purpose of this study is to see if adding the study drug, BMS-650032 (a tablet) to standard treatment is safe and more effective than standard treatment alone in patients with HCV genotypes 1 and 4. Of the 300 patients to be treated worldwide, two fifths will receive dose A of BMS-650032, two fifths will receive dose B of BMS-650032 and one fifth will receive dummy drug. All patients will receive standard treatment. UK recruitment starts in October, 2010 and will end in early 2011. The study is funded by Bristol-Myers Squibb, and is being carried out in London, Glasgow, Manchester and Hull. Patients who consent to taking part in the study will undergo: 1. Screening: physical examination, heart function tests and blood tests. 2. Randomisation: patients will be randomised to receive standard treatment plus either dose A of study drug, dose B of study drug or placebo. It will not be known which treatment patients will receive. [This study design is called ??double-blind??.] 3. Treatment: the duration of this depends on a patient??s response to treatment and any side effects they may experience. 4. End of Treatment: physical examination, heart function tests and blood tests. 5. Follow-Up: blood tests. Women taking part in the study who are able to become pregnant will have pregnancy tests carried out at all stages of the study. This is because ribavirin can be very harmful to the unborn child and it may cause birth defects.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
10/H0803/53
Date of REC Opinion
15 Jun 2010
REC opinion
Further Information Favourable Opinion