Evaluation of BMS-790052 with Peg-Interferon Alpha-2a + Ribavirin (v1)
Research type
Research Study
Full title
A Phase 3 Evaluation of BMS-790052 in Combination with Peg-Interferon Alpha-2a and Ribavirin in Treatment-Naive Subjects with Chronic Hepatitis C Genotype 4
IRAS ID
93196
Contact name
Ashley Brown
Sponsor organisation
Bristol Myers Squibb
Eudract number
2011-002793-23
Clinicaltrials.gov Identifier
Research summary
Title: A Phase 3 Study of Peg-Interferon Alpha-2a (Pegasys), Ribavirin (Copegus) with or Without BMS-790052 in Treatment-naive Patients with Chronic Hepatitis C infection. Treatment options for patients with Hepatitis C virus (HCV) infection are limited. Current therapy involves 24-48 weeks of treatment with pegylated interferon alpha-2a(pegIFNa) and ribavirin. This combination has limited effectiveness in some patients and they are also poorly tolerated in some patients. This highlights the unmet medical need for new therapeutics. The study drug, BMS-790052 (a tablet), is being studied as a potential treatment option to help address this need. The purpose of this study is to find out about the safety and effectiveness of the study drug BMS-790052, when it is added with pegIFNa & ribavirin for a total of 24 or 48 weeks of treatment. Of the 120 patients to be treated worldwide, two-thirds of patients will receive the study drug BMS-790052 and one-third of patients will receive a dummy drug. All patients will receive pegIFNa & ribavirin. Neither the doctor nor the patient will know if the patient is receiving the study drug BMS-790052 or the dummy drug (except if deemed absolutely necessary). This study design is called ??randomised double-blind??. Participating patients will undergo: physical examinations, multiple blood tests, a heart function test and regular pregnancy tests (as ribavirin can cause birth defects). Patients will be regularly monitored and their treatment will be stopped if they do not respond or are unable to tolerate any side effects. Globally, the study will begin in December 2011 and approximately 120 patients will be treated worldwide. In the UK, the study is expected to begin in March 2012 and is due to end in January 2014. The study is funded by Bristol-Myers Squibb.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
12/SC/0031
Date of REC Opinion
7 Mar 2012
REC opinion
Further Information Favourable Opinion