Antiviral Stat-C Protease Inhibitor Regimen in Experienced Subjects

• Research type

  Research Study

• Full title

  A Phase IIb, randomized, double-blind, placebo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of a treatment regimen including PegIFNa-2a and ribavirin in HCV genotype 1 infected subjects who failed to respond or relapsed following at least 1 course of PegIFNa-2a/b and RBV therapy. (ASPIRE)

• IRAS ID

  25142

• Contact name

  Graham Foster

• Sponsor organisation

  Tibotec Pharmaceuticals

• Eudract number

  2009-010590-20

• ISRCTN Number

  not given

• Research summary

  This is a multicentre study of TMC435 in hepatitis C-infected subjects. Approximately 540 subjects who are infected with genotype 1 Hepatitis C Virus infection (HCV) and who have failed at least one prior course of Standard of Care therapy against HCV infection will be screened in this study. The aim is to enrol 455 subjects, 40% of whom have relapsed on previous therapy, 40% who have only partially responded and 20% who have failed to respond at all to previous therapy.The effectiveness, tolerability and safety of different treatment combinations of the new drug TMC435 plus peginterferon and ribavirin, versus standard of care treatment (peginterferon and ribavirin alone) will be assessed.The study will be performed in phases: Screening Phase (approximately 6 weeks); Investigational Treatment Phase (48 weeks); and Treatment Free Follow-up Period (24 weeks).There are 7 possible treatment groups: Groups 1 & 2: Treatment with TMC435 for 12 weeks (dose varies between groups) together with the standard treatment. Then placebo together with the standard treatment for an additional 36 weeks. Groups 3 & 4: Treatment with TMC435 for 24 weeks (dose varies between groups) together with the standard treatment. Then placebo together with the standard treatment for an additional 24 weeks. Groups 5 & 6: Treatment with TMC435 for 48 weeks (dose varies between groups) together with standard treatment.Group 7: Control group who will not receive TMC435 but will receive the standard treatment together with the placebo for 48 weeks.Patient reported outcomes will be assessed in addition to objective endpoints such as virologic response to treatment.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  09/H0713/61

• Date of REC Opinion

  1 Dec 2009

• REC opinion

  Further Information Favourable Opinion