Rollover trial of Peg, RBV, BMS790052 +/- BMS650032 in HCV adults

• Research type

  Research Study

• Full title

  Clinical Protocol AI444026: An Open-Label Re-treatment Study with Peg-Interferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

• IRAS ID

  84479

• Contact name

  Ashley Brown

• Sponsor organisation

  Bristol Myers Squibb (BMS)

• Eudract number

  2011-000836-27

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Standard treatment options for patients with Hepatitis C virus (HCV) infection are limited. Current therapy involves 24-48 weeks of treatment with pegylated interferon alpha (PegIFN) and Ribavirin. This combination has limited effectiveness, in some patients, especially in patients infected with HCV genotype 1, and they are also poorly tolerated in some patients highlighting the unmet medical need for new therapeutics.The study drugs, BMS-650032 and BMS-790052, both tablets, are being studied as potential treatment options to help address this need. The purpose of this study is to find out about the safety and effectiveness of the study drugs, BMS-650032 and BMS-790052, when they are added to standard treatment of PegIFN & Ribavirin for a total of 24 weeks of treatment.Patients with Genotypes 1 and 4 who have previously participated in the BMS AI447-016 trial and received treatment with PegIFN, Ribavirin & placebo that was not effective at suppressing their HCV, will be eligible to participate. Participating patients will undergo physical examinations, multiple blood tests, a heart-functions 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 August 2011; approximately 300 patients will participate. In the UK the study will begin in October 2011 and close around August 2014; up to 4 patients are expected to participate. The study is funded by Bristol-Myers Squibb.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/SC/0358

• Date of REC Opinion

  21 Oct 2011

• REC opinion

  Further Information Favourable Opinion