AI452-016 Observational f’up from BMS-914143 Hepatitis C trials
Research type
Research Study
Full title
Observational Study Protocol AI452-016: A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in which Peginterferon Lambda-1a (BMS-914143) was Administered for the Treatment of Chronic Hepatitis C
IRAS ID
139952
Contact name
Graham R Foster
Contact email
Sponsor organisation
Bristol-Myers Squibb
Clinicaltrials.gov Identifier
Research summary
Current treatment options for patients with Hepatitis C virus (HCV) infection involve 24-48 weeks of treatment with pegylated interferon alfa2a/alfa2b (Peg) and Ribavirin (RBV) with a protease inhibitor. The profile and results of this combination has left unmet medical needs for new therapeutics.
BMS-914143 is being studied with or without RBV and/or direct acting antiviral agents (DAAs) 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 investigational combination in suppressing HCV after study treatment has stopped. This study will follow patients previously treated in any BMS-914143 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 began in March 2012; approximately 1000 patients will participate. In the UK the study will begin in Jan-2014; 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 - Riverside Research Ethics Committee
REC reference
14/LO/0014
Date of REC Opinion
16 Jan 2014
REC opinion
Favourable Opinion