TMC435C208 : treatment-naïve genotype 1 hepatitis C-infected subjects

• 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 treatment-naïve, genotype 1 hepatitis C-infected subjects

• IRAS ID

  67363

• Contact name

  Graham Foster

• Eudract number

  2010-020444-36

• ISRCTN Number

  Not Known

• Research summary

  The options 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 virus (HCV). This study will assess how well TMC435 will work on slowing down or stopping the growth of HCV when given along SoC therapy. A target of 375 adult subjects who have genotype 1 hepatitis C, and who have not previously received treatment for this, will be included in this trial. There are two different treatment arms: on one arm subjects will receive TMC435 and the other arm will receive placebo (this is a dummy drug). The decision will be made randomly with double the number of subjects being treated with TMC435 compared to placebo. Both arms of the study will also receive SoC treatment. The treatment period will be either 24- or 48-weeks, and this is determined by how the subject is responding to the treatment. All subjects will be followed up after completing the treatment period until Week 72 regardless of when they stop treatment. There is an option to participate in a DNA study which requires one additional blood sample to be taken. If the subject consents this will be used to test how differences in genes alter the response subjects have to drugs.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  11/H0706/6

• Date of REC Opinion

  14 Feb 2011

• REC opinion

  Further Information Favourable Opinion