BI 207127 in Treatment-Naïve Patients with HCV

• 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 in Treatment-Naïve Patients with Chronic Genotype 1 HCV Infection.

• IRAS ID

  114232

• Sponsor organisation

  Boehringer Ingelheim Ireland Ltd.

• Eudract number

  2012-003533-41

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Current standard of care (SOC) for HCV GT1 comprises of response guided treatment (up to 48 weeks) with pegylated interferon (given as a subcutaneous injection), ribavirin and a protease inhibitor (telaprevir/boceprevir). Whilst this has improved response rates there remains a significant side effect profile, of which pegylated interferon is a major contributor. This limits response rates and tolerability. This is a phase III study looking at efficacy and safety of BI 207127 in combination with Faldaprevir and Ribavirin in patients who have previously not received any treatment for their Hepatitis C (HCV) infection and to investigate whether there is a difference between 16 and 24 weeks of treatment. Approximately 800 patients will be screened and approximately 540 patients with chronic HCV GT1 infection will be randomised to one of 3 treatment arms. A combination treatment of BI Faldeprevir and BI 207127 with ribavirin without pegylated interferon may have significantly fewer side effects and better tolerability. This combined treatment may provide a shorter and more convenient treatment option for patients with chronic HCV infection. In addition, this treatment can be given to patients who are unable (for whatever reason) to receive pegylated interferon.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0540

• Date of REC Opinion

  19 Dec 2012

• REC opinion

  Further Information Favourable Opinion