TMC435 for relapsed genotype 1 Hepatitis C virus infection
Research type
Research Study
Full title
A Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of TMC435 vs. placebo as part of a treatment regimen including peginterferon alfa-2a and ribavirin in hepatitis C, genotype 1 infected subjects who relapsed after previous interferon-based therapy
IRAS ID
67364
Contact name
Ashley Brown
Contact email
Eudract number
2010-021113-23
ISRCTN Number
Not Known
Research summary
The options available to treat Hepatitis C infections are limited and therefore,the development of new and better Hepatitis C antiviral drugs is essential. The current Standard of Care therapy (SoC) for treatment of chronic Hepatitis C infection is a combination of two drugs, pegylated interferon and ribavirin.
TMC435 is in process of development for the treatment of subjects with chronic Hepatitis C (CHC).
This study will assess how well TMC435 will work on slowing down or stopping the growth of HCV when given alongside SoC (pegylated interferon and ribavirin) therapy and investigate how safe and well tolerated TMC435 is when given along with SoC to treat patients with HCV. Subjects will be males or females diagnosed with Hepatitis C virus (HCV) infection who has had a relapse, after previous treatment with a(pegylated) interferon-based therapy. A relapse means that a subject’s hepatitis C infection came back after the first round of treatment. This means that the virus is not cleared from the subject’s body.
Approximately, 375 subjects will take part in this study. The subjects will receive either TMC435 (TMC435 150mg once daily plus SoC for 12 weeks followed by additional 12-36 weeks of SoC therapy depending on how they respond to the treatment) or Placebo (a dummy treatment) once a day plus SoC therapy (pegylated interferon + ribavirin) for 12 weeks, followed by an additional 36 weeks of SoC therapy. The maximal duration of subject’s participation in this study is 78 weeks. The study procedures include a screening period of 6 weeks and a treatment and follow-up period of 72 weeks.
REC name
London - Riverside Research Ethics Committee
REC reference
11/H0706/5
Date of REC Opinion
14 Feb 2011
REC opinion
Further Information Favourable Opinion