Study of Asunaprevir + Daclatasvir in subjects with HCV G1b Infection

• Research type

  Research Study

• Full title

  Clinical Protocol AI447-028: A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects with Chronic Hepatitis C Genotype 1b Infection

• IRAS ID

  105757

• Contact name

  Daniel Forton

• Sponsor organisation

  Bristol-Myers Squibb

• Eudract number

  2011-005446-35

• Clinicaltrials.gov Identifier

  NCT01581203

• Research summary

  The ??standard of care?? therapy for Hepatitis C virus (HCV) patients involves 24 weeks of treatment with one of the ??Direct Acting Antiviral?? (DAA) drugs in combination with peginterferon alfa (pegIFNa) and ribavirin (P/R). The above treatment option has limited effectiveness in some patients and the drugs are also poorly tolerated in some patients. This highlights the unmet need for new therapeutic options. The study drugs, daclatasvir and asunaprevir, in this clinical trial are both DAA drugs and are being studied as a potential new treatment option. There will be three groups of patients in this study: Group 1: Patients who have previously not responded to treatment with P/R. Group 2: Patients who cannot be treated with P/R due to a co-existing medical condition. Group 3: Patients who have not previously received any treatment for HCV. Groups 1 and 2: The patients in Groups 1 and 2 above will receive both daclatasvir and asunaprevir (both are tablets) for 24 weeks and will then be followed-up for 24 weeks. Group 3: Of the 300 patients to be treated in group 3: - two-thirds of patients will receive both daclatasvir and asunaprevir for 24 weeks and will then be followed-up for 24 weeks - one-third of patients will receive placebo tablets (??dummy? drugs) for 12 weeks and will then transfer to a different clinical trial (in which they will receive daclatasvir and asunaprevir) For the first 12 weeks of the study, neither the doctor nor the patients will know if the patients in Group 3 are receiving the study drugs or placebo (except if deemed absolutely necessary). Globally, the study will begin in June 2012 and approximately 725 patients will be treated worldwide. In the UK, the study is expected to begin in July 2012. The study is funded by Bristol-Myers Squibb.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/0827

• Date of REC Opinion

  3 Aug 2012

• REC opinion

  Further Information Favourable Opinion