A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Debio 025 (alisporivir) is an oral cyclophilin inhibitor with a new mechanism of action
      demonstrating potent anti-hepatitis C virus (HCV) activity in pre-clinical models and
      patients.

      The current standard of care (SOC) in HCV patients consists of a combination of peg-IFN alpha
      and ribavirin. Treatment duration and ribavirin dose depend on the genotype treated. Only
      40-50% of patients with genotype 1 achieve a sustained viral response (SVR). This study
      assesses whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin
      can improve the outcome of treatment in this group of patients.
    

Detailed description: 
      This is a multicentre, open-label, randomized, 5 arm parallel-group, multiple dose study in
      50 chronic hepatitis C virus (HCV) genotype 1 non-responders to standard treatment with
      peg-IFN alpha (2a or 2b) and ribavirin. The entire study lasts a maximum of 96 weeks and
      consists of a 48- or 72-week treatment period (according to response). A follow-up visit to
      assess the sustained viral response (SVR) takes place 24 weeks after treatment cessation,
      i.e., at study Week 72 or 96, or earlier for discontinued study participants.

      There were 2 parts in the treatment period. Part 1 lasted from Day 1 to Day 29 (Weeks 1 to
      4); Part 2 lasted from Week 5 to Week 48 or 72.

      During Part 1 of treatment (Weeks 1 to 4), participants are randomized to 1 of 5 treatment
      arms and receive 4 weeks of Debio 025 (alisporivir) monotherapy, Debio 025 combined with
      standard dose peg-IFNα2a, or 1 of 3 triple therapies combining different doses of Debio 025
      with peg-IFNα2a and ribavirin at standard doses.

      During Part 2 of treatment (Weeks 5 to 48 or 72), participants receive standard doses of
      peg-IFNα2a/ribavirin dual therapy for 44 or 68 weeks, depending on their response to
      treatment. At Week 12, participants who do not achieve ≥ 2 log10 decrease in HCV RNA are
      withdrawn and considered treatment failures. Participants who have undetectable HCV RNA
      levels and/or ≥ 2 log10 decrease in HCV RNA continue treatment until Week 24. At Week 24,
      participants who still have detectable HCV RNA levels are withdrawn and considered treatment
      failures. Participants with undetectable HCV RNA levels at Weeks 12 and 24 continue treatment
      until Week 48. At Week 24, "slow responders" (defined as participants with a detectable, but
      > 2 log10 decrease in HCV RNA levels at Week 12 and undetectable levels at Week 24) are
      eligible to continue treatment until Week 72.
    

Intervention name(s): Debio 025; Peg-IFNα2a; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Debio 025 supplied as a 100 mg/mL oral solution; Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes; Ribavirin supplied as 200 mg tablets
Other intervention name(s): Alisporivir; PEGASYS; Copegus
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis; Hepatitis C