A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure Patients With Chronic Hepatitis C Genotype 1
Overview
- Phase
- Phase 3
- Intervention
- Alisporivir
- Conditions
- Hepatitis C
- Sponsor
- Debiopharm International SA
- Enrollment
- 6
- Locations
- 3
- Primary Endpoint
- Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Alisporivir
ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
Intervention: Alisporivir
Alisporivir
ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
Intervention: Peginterferon alfa-2a
Alisporivir
ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
Intervention: Ribavirin
Outcomes
Primary Outcomes
Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
Time Frame: 12 weeks posttreatment
SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.
Secondary Outcomes
- Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)(12 weeks posttreatment)
- Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)(24 weeks posttreatment)
- Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events(48 weeks)