Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Alisporivir
* Drug: Peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with chronic HCV genotype 1 infection with previous PI treatment failure Three months minimum time from the last dose of previous PI treatment to the first dose of study medication Exclusion criteria: Use of other investigational drugs at the time of enrollment History of hypersensitivity to PEG or RBV Any null non-responders to prior PEG/RBV treatment Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alisporivir<br>ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks | Drug: Alisporivir<br>* ALV 200 mg soft gel capsules administered orally<br>* Other names: DEB025;Drug: Peginterferon alfa-2a<br>* PEG 180 μg administered via subcutaneous (s.c.) injection once weekly<br>* Other names: Pegasys®;Drug: Ribavirin<br>* RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose<br>* Other names: RBV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12) | 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. | 12 weeks posttreatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) | SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment. | 24 weeks posttreatment | 
| Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD) | Level of detection (LOD) was defined as 10 IU/mL | 12 weeks posttreatment | 
| Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, PI treatment failure