pegIFN Lambda/RBV/TVR or pegIFN Alfa/RBV/TVR HCV G1 Naive or Relapsed
Research type
Research Study
Full title
AI452-020 - A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered with Telaprevir in Subjects with Genotype-1 Chronic Hepatitis C who are Treatment-naive or Relapsed on Treatment with Peginterferon Alfa and Ribavirin
IRAS ID
132056
Contact name
Ashley Brown
Contact email
Sponsor organisation
Bristol Myers Squibb
Eudract number
2011-004695-11
ISRCTN Number
n/a
Research summary
Approximately 3% of the world’s population are infected with Hepatitis C virus (HCV). Treatment options for patients chronically infected are limited. Patients with Genotype 1 will be recruited.
Recently, direct-acting antivirals (DAAs) Telaprevir (TVR) and Boceprevir (BOC) have been approved in addition to standard of care Alfa/RBV for GT-1 patients. These DAAs are associated with adverse events of skin rash and bone marrow suppression. Associated with Alfa are flu-like symptoms, anaemia and depression. RBV is associated with anaemia. This often results in delays in treatment start, dose reductions and early discontinuations.
The study drug pegInterfon Lambda-1a (Lambda), is being studied as a potential new treatment option. The combination of Lambda/TVR/RBV has the potential to be a highly effective treatment when compared to Alfa/TVR/RBV.
The treatment arms are designed to show if untreated or relapsed patients will show similar viral response to Lambda/RBV/TVR as to Alfa/RBV/TVR. Participants will be randomised to one of two treatment arms for 24 or 48 weeks. Follow up will be for 48 weeks. A total duration of up to 96 weeks. All study treatment will be blind.
Alfa and Lambda are taken by injection under the skin. Ribavirin and Telaprevir are taken in tablet form.
Patients will undergo physical examinations, multiple blood tests, a heart function test and regular pregnancy tests, a liver biopsy or fibroscan may be required. Patients will have an eye exam, be asked to complete a medication diary and will be regularly monitored. Treatment will be stopped if they do not respond or cannot tolerate side effects.
The study will begin in March 2013 and end in January 2016. Approximately 609 patients will participate worldwide and 20 in UK at four NHS sites. The study is funded by Bristol-Myers Squibb.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0360
Date of REC Opinion
14 Aug 2013
REC opinion
Further Information Favourable Opinion