BI 207127 with faldaprevir and ribavirin in Hepatitis C patients

• Research type

  Research Study

• Full title

  A phase III randomised, partially double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1 hepatitis C infection in an extended population of treatment naïve patients that includes those ineligible to receive peginterferon.

• IRAS ID

  113660

• Contact name

  Daniel Forton

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2012-003535-27

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  This is a phase III study looking at the safety and efficacy of a combined treatment of faldaprevir, BI 207127 and ribavirin for chronic genotype 1 hepatitis C infection in patients who have not received treatment before for their Hepatitis C infection, including those patients who cannot receive peginterferon. The study will be conducted in approximately 158 sites in 14 countries, recruiting approximately 590 patients. The combination of Faldaprevir and BI 207127 with Ribavirin has shown good virological response (84% - SVR 12 (the proportion of patients with no detectable virus 12 weeks after the end of treatment)) in a subset of patients infected with Hepatitis C (Hepatitis C Genotype GT1b). This study will look at the response of the Hepatitis C virus to this combination of 3 oral medications while also monitoring the patients safety.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  12/LO/1590

• Date of REC Opinion

  7 Dec 2012

• REC opinion

  Further Information Favourable Opinion