BI 207127 & Faldaprevir in patients with hepatic impairment with HCV

• Research type

  Research Study

• Full title

  A phase II randomised, double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection

• IRAS ID

  115724

• Contact name

  Kosh Agarwal

• Sponsor organisation

  Boehringer Ingelheim Limited

• Eudract number

  2012-003534-17

• ISRCTN Number

  xxx

• Clinicaltrials.gov Identifier

  NCT01830127

• Research summary

  This is a phase II randomised, double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection. The currently available treatment options for chronic HCV infection include a combination of drugs that includes pegylated interferon and ribavirin. These treatments have many side effects and include weekly injections of pegylated interferon. A combination treatment of faldaprevir and BI 207127 with ribavirin without pegylated interferon may be associated with fewer side effects. Up to 165 treatment naïve patients with hepatitis C infection (HCV) are planned to be entered in this study.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  13/LO/0268

• Date of REC Opinion

  5 Mar 2013

• REC opinion

  Favourable Opinion