AI444-046 Observational f’up from BMS-650032/790052 Hepatitis C trials
Research type
Research Study
Full title
Observational Study Protocol AI444-046: A Long-Term Follow-up Study of Subjects Who Participated in A Clinical Trial in Which BMS-650032 and/or BMS-790052 Was Administered for the Treatment of Chronic Hepatitis C
IRAS ID
96552
Contact name
Kosh Agarwal
Sponsor organisation
Bristol Myers Squibb (BMS)
Eudract number
2011-005287-21
Clinicaltrials.gov Identifier
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 alfa2a/alfa2b (Peg) and Ribavirin (RBV). This combination has limited effectiveness and is also poorly tolerated in some patients, highlighting the unmet medical need for new therapeutics. Treatment with BMS-650032 and/or BMS-790052 is being studied in combination with Peg and RBV for its role as a potential treatment option in combination therapy for patients with chronic hepatitis C (CHC). Little is known about the long-term safety and effectiveness of this combination in suppressing HCV, after study treatment has stopped. This study will follow patients previously treated in any BMS-650032 or BMS-790052 study, for 3 years after their participation in the previous (??parent??) study has ended. This study aims to assess whether the treatment received in the parent study will continue to be effective in suppressing HCV up to 3 years after study treatment has stopped. For patients where HCV is detected, this study will also determine if the virus that is present is less responsive to treatment. This study will also assess if patients liver disease worsens. This study is designed to follow the timing of visits for patients that is consistent with standard of care for CHC. Participating patients will attend 7 clinic visits over 3 years (approximately every 6 months). During clinic visits patients will be asked about their lifestyle & medical history and will undergo a short physical examination and blood test. Phone contacts are also scheduled twice yearly. Globally, the study will begin in Jan-2012; approximately 1000 patients will participate. In the UK the study will begin in Mar-2012, approximately 50 patients will participate. The total number of patients will increase with the addition of parent trials. The study is funded by Bristol-Myers Squibb.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
12/LO/0095
Date of REC Opinion
27 Mar 2012
REC opinion
Further Information Favourable Opinion