Safety and Efficacy Study of Boceprevir/PegI/Ribavirin -Short Duration

• Research type

  Research Study

• Full title

  A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects

• IRAS ID

  97882

• Contact name

  Geoffrey Dusheiko

• Sponsor organisation

  Schering Corporation, a Subsidiary of Merck & Co., Inc.

• Eudract number

  2011-001345-32

• Clinicaltrials.gov Identifier

  NCT01544920

• Research summary

  Previously untreated adult subjects with confirmed compensated chronic hepatitis C genotype 1, without cirrhosis, with IL28b CC allele gene, will be selected to participate in the trial. The aim of the study is to evaluate the safety, tolerability and efficacy of two Boceprevir containing therapeutic regimens when administered together with Peginterferon alfa-2a and Ribavirin. All subjects will receive Peginterferon alfa-2a and Ribavirin for 4 weeks and then will be randomised to Arm 1 or Arm 2 of the study. Each arm will contain 2 sub groups. Patients will be assigned to the sub groups within Arm 1 and Arm 2, based on the results of a Hepatitis C virus blood test. Dependent on the treatment arm that the patient is randomised to, the patient may receive between 20 and 44 weeks of additional treatment. In previous studies subjects with chronic hepatitis C, genotype 1 with the IL28 CC allele gene, experienced a more rapid virologic response than non-CC allele subjects, suggesting that a shorter duration therapy with Boceprevir, Peginterferon and Ribavirin may be effective in this population.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0663

• Date of REC Opinion

  10 Jul 2012

• REC opinion

  Further Information Favourable Opinion