Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

Brief Summary

Official Title: “A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment”

The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2013

Interventions Used in this Clinical Trial

  • Drug: Alisporivir
    • ALV 200 mg soft gel capsules administered orally
  • Drug: Peginterferon alfa-2a
    • PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
  • Drug: Ribavirin
    • RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
  • Drug: Placebo
    • ALV placebo soft gel capsules administered orally

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Treatment A: ALV 600 mg QD
    • Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
  • Experimental: Treatment B: ALV 800 mg QD
    • Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
  • Experimental: Treatment C1: ALV Placebo – 600 mg QD
    • ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
  • Experimental: Treatment C2: ALV Placebo – 400 mg BID
    • ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
  • Experimental: Treatment D: ALV 400 mg BID
    • Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks

Outcome Measures for this Clinical Trial

Primary Measures

  • Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
    • Time Frame: after 12 weeks of treatment
      Safety Issue?: No

Secondary Measures

  • Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
    • Time Frame: after 12 weeks of treatment
      Safety Issue?: No
  • Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
    • Time Frame: 12 weeks after treatment
      Safety Issue?: No
  • Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
    • Time Frame: 24 weeks after treatment
      Safety Issue?: No
  • Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
    • Time Frame: after 4 weeks of treatment
      Safety Issue?: No
  • Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
    • Time Frame: after 12 weeks of treatment
      Safety Issue?: No
  • Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
    • Time Frame: within 48 weeks
      Safety Issue?: No
  • Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
    • Time Frame: Up to 48 weeks
      Safety Issue?: No
  • Percentage of Participants With On-treatment Viral Breakthrough
    • Time Frame: within 48 weeks
      Safety Issue?: No
  • Percentage of Participants With Viral Relapse
    • Time Frame: within 24 weeks after treatment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Chronic HCV genotype 1 viral infection
  • HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
  • Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks

Exclusion Criteria

  • Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
  • Women of child-bearing potential unless using highly effective
  • Any other cause of relevant liver disease other than HCV
  • Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Debiopharm International SA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01183169