Evaluation of PegIFN Lambda/Daclatasvir/Ribavirin in G2 and G3 HCV
Research type
Research Study
Full title
AI452-017 - A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, with and without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination with Ribavirin, in the Treatment of Naive Genotype 2 and 3 Chronic Hepatitis C Subjects
IRAS ID
107615
Contact name
Graham R Foster
Sponsor organisation
Bristol Myers Squibb
Eudract number
2011-004885-14
Clinicaltrials.gov Identifier
Research summary
Treatment options for patients chronically infected with Hepatitis C virus (HCV) infection are limited. In this study, patients with Genotype 2 or Genotype 3 will be recruited. Patients are often unaware of any symptoms in the early stages of infection, and usually present with chronic disease. Current treatment involves taking two drugs called pegylated interferon alfa 2a (Alpha) and ribavirin (RBV) for 24-48 weeks. This combination has limited effectiveness in some patients and is often poorly tolerated. Alfa has many side effects and studies with lambda suggest that the side effects are less. This study will look at three treatment arms. Alfa plus RBV for 24 weeks compared to Pegylated interferon Lambda-1a (Lambda) plus RBV for 24 weeks, compared to Lambda plus Daclatasvir plus RBV for 12 weeks. Both Lambda and Daclatasvir are being investigated for safety and effectiveness. Patients will be randomised (like the toss of a coin) in the ratio two to Lambda and RBV, two to Lambda, RBV and Daclatasvir, one to Alfa and RBV. Of the treatments mentioned, Alfa and also Lambda are taken by injection under the skin. Ribavirin and Daclatasvir are taken in tablet form. Patients will be followed for between 48 and 60 weeks, depending on the treatment arm, and will undergo physical examinations, multiple blood tests, a heart function test and regular pregnancy tests (RBV can cause birth defects). A liver biopsy or fibroscan may also be required. Patients will 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. Globally the study will begin in July 2012 and approximately 875 patients will participate worldwide. In the UK, the study will begin in August 2012 and is due to end in September 2014. The study is funded by Bristol-Myers Squibb.
REC name
London - Harrow Research Ethics Committee
REC reference
12/LO/1223
Date of REC Opinion
20 Nov 2012
REC opinion
Further Information Favourable Opinion