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

Debiopharm

Status and phase: Terminated; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Ribavirin; Drug: Alisporivir; Drug: Peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT01500772

CDEB025A2306

2011-004653-31 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Alisporivir

Experimental group

Description:

ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks

Treatment:

Drug: Peginterferon alfa-2a

Drug: Ribavirin

Drug: Alisporivir