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

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Debiopharm International SA
• Treatments: HIV Protease Inhibitors; Peginterferon alfa-2a; Protease Inhibitors; Ribavirin

Criteria

Inclusion criteria:

1. Patients with chronic HCV genotype 1 infection with previous PI treatment failure

2. Three months minimum time from the last dose of previous PI treatment to the first dose of study medication

Exclusion criteria:

1. Use of other investigational drugs at the time of enrollment

2. History of hypersensitivity to PEG or RBV

3. Any null non-responders to prior PEG/RBV treatment

Other protocol-defined inclusion/exclusion criteria may apply.