Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option

Debiopharm

Status and phase: Completed; Phase 2

Conditions: Hepatitis C; Liver Disease

Treatments: Drug: Ribavirin; Drug: Alisporivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094443

CDEB025A2233

2013-003751-38 (EudraCT Number)

Details and patient eligibility

About

The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent must be obtained before any assessment is performed
2. Participants with HCV genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon
3. Males or females aged ≥18 years
4. Diagnosed Chronic hepatitis C virus infection

Exclusion criteria

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
3. Hepatitis B surface antigen (HBsAg) positive
4. Human immunodeficiency virus (HIV) positive

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Alisporivir 300 mg BID

Experimental group

Description:

Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication

Treatment:

Drug: Ribavirin

Drug: Alisporivir

Alisporivir 400 mg BID

Experimental group

Description:

ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication

Treatment:

Drug: Ribavirin

Drug: Alisporivir