Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

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

Summary

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and

3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Debiopharm International SA
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion criteria:

• Chronic hepatitis C viral infection

• Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)

• HCV genotype 2 or 3

• No previous treatment for hepatitis C infection

Exclusion criteria:

• Evidence of cirrhosis at the time of screening

• Evidence of hepatocellular carcinoma at the time of screening

• Any other cause of relevant liver disease other than HCV

• Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)

• Other protocol-defined inclusion/exclusion criteria may apply