1220.30 Phase III trial in treatment-naive Hepatitis C patients

• Research type

  Research Study

• Full title

  A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 120 mg for 12 or 24 weeks or BI 201335 240 mg for 12 weeks in combination with pegylated interferon-a and ribavirin in treatment-naïve patients with genotype 1 chronic hepatitis C infection.

• IRAS ID

  51762

• Contact name

  Kosh Agarwal

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2010-021716-42

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a Phase III, randomised trial to look at the efficacy of two different treatment regimens of BI 201335 given for 12 or 24 weeks in combination with pegylated interferon-a and ribavirin (PegIFN/RBV; current standard of care treatment) compared to standard of care alone, in treatment of Hepatitis C virus genotype-1 infected patients who have not previously been treated for Hepatitis C. 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/0007

• Date of REC Opinion

  21 Mar 2011

• REC opinion

  Further Information Favourable Opinion