TMC435HPC3001(ATTAIN)

• Research type

  Research Study

• Full title

  A Phase III, randomized, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. telaprevir, both in combination with PegIFNa-2a and ribavirin, in chronic hepatitis C genotype-1 infected subjects who were null or partial responders to prior PegIFNa and ribavirin therapy.

• IRAS ID

  93673

• Contact name

  Kosh Agarwal

• Sponsor organisation

  Tibotec Pharmaceuticals

• Eudract number

  2011-001180-53

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The current Standard of Care therapy (SoC) for treatment of chronic Hepatitis C infection is a combination of two drugs, pegylated interferon (PegIFNÇ­-2a) and ribavirin. Telaprevir is approved for the treatment of adults with chronic hepatitis C (genotype 1) when it is used in combination with PegIFNÇ­-2a/ ribavirin. TMC435 is in development for the treatment of subjects with chronic Hepatitis C (CHC). Both TMC435 and telaprevir are "protease inhibitors" which is a class of drug that work by blocking an enzyme (called "protease") that the Hepatitis C virus needs for its replication. The purpose of this research study is to find out if TMC435 (plus PegIFNÇ­-2a/ ribavirin) works at least as well as telaprevir (plus PegIFNÇ­-2a/ ribavirin) to treat patients with chronic hepatitis C virus genotype 1 infection who have had a response to treatment with PegIFNÇ­-2a and ribavirin that was insufficient to clear the hepatitis C virus from their body [previous treatment failure]. About 744 male and female subjects worldwide will take part in this study. There are two treatment groups in this study: ?½ Treatment Group 1: TMC435 150 mg daily plus PegIFNÇ­-2a/ ribavirin for 12 weeks followed by PegIFNÇ­-2a/ ribavirin alone until week 48. ?½ Treatment Group 2: Telaprevir 750 mg (3x/day) plus PegIFNÇ­-2a/ribavirin for 12 weeks followed by PegIFNÇ­-2a/ ribavirin alone until week 48. In addition to active treatment, patients in each treatment group will also receive placebo capsules or tablets. (Placebo looks like the actual drug but has no active ingredients, for example, a sugar pill). The active TMC435 group will receive placebo Telaprevir tablets. The active Telaprevir group will receive TMC435 placebo capsules. The study will consist of a screening period with a duration of approximately 6 weeks, followed by a 48-week treatment period and a follow-up period until 72 weeks after the start of treatment.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  12/SC/0042

• Date of REC Opinion

  12 Mar 2012

• REC opinion

  Further Information Favourable Opinion