1220.7 Phase III trial in treatment-experienced Hepatitis C patients

• Research type

  Research Study

• Full title

  A phase III, randomised, double-blind and placebo controlled study of once daily BI 201335, 240 mg for 12 or 24 weeks in combination with pegylated interferon-a and ribavirin in patients with genotype 1 chronic hepatitis C infection who failed a prior PegIFN/RBV treatment

• IRAS ID

  78554

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2010-021715-17

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a phase III multi-national, randomised, double-blind, placebo-controlled, parallel group trial. It is planned to include a total of 625 patients with chronic hepatitis C infection of genotype 1 who failed prior PegIFN/RBV treatment.Treatment experienced patients will be enrolled into one of three cohorts based on one of the three following definitions:?½Prior Relapse - Cohort 1, or,?½Prior Partial response - Cohort 2, or,?½Prior Null-response - Cohort 3 (see definitions described in section A)Hepatitis C genotype-1 infected patients have the poorest response rate to standard of care treatment. Treatment is successful in approximately 45% of genotype-1 patients. Patients who fail treatment face serious progression of their disease to liver damage (cirrhosis) and cancer.In combination with standard of care treatment, BI 201335 has shown a rapid, strong and maintained antiviral activity and good levels of early virological response and therefore an increased chance of a successful treatment response.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/SC/0176

• Date of REC Opinion

  12 Jul 2011

• REC opinion

  Further Information Favourable Opinion