1220.48 Phase III roll-over trial in TE Hepatitis C patients

• Research type

  Research Study

• Full title

  A phase III, open-label study of once daily BI 201335 240 mg for 24 weeks in combination with pegylated interferon-a (PegIFN) and ribavirin (RBV) in patients with genotype 1 chronic hepatitis C infection who failed a prior PegIFN / RBV treatment

• IRAS ID

  80293

• Sponsor organisation

  Boehringer Ingelheim Limited

• Eudract number

  2011-000141-20

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a Phase III, open label trial enrolling into two cohorts. Patients will be placed into one of two treatment cohorts dependent on the patients previous response to treatment. It is planned to include approximately 200 treatment experienced patients who have failed on the placebo arm (have not received any BI 201335) of the phase III BI 201335 trials with chronic HCV infection of GT-1. Only patients enrolled previously in the BI201335 trials will be eligible.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. This rollover trial will offer patients with virological failure in the placebo controls of the Phase III trials 1220.7, 1220.30 and 1220.47 open label treatment with BI 201335/ PegIFN/ RBV and the potential for additional efficacy.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/SC/0177

• Date of REC Opinion

  12 Jul 2011

• REC opinion

  Further Information Favourable Opinion