Conditions: Hepatitis C Chronic Pain
Keywords: Chronic hepatitis C genotype 2 Chronic hepatitis C genotype 3 Cyclophilin inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 340
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24. arm 2: Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24. arm 3: Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. arm 4: Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24. arm 5: Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.

Interventions: intervention 1: Alisporivir intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin
Intervention descriptions: intervention 1: ALV 200 mg soft gel capsules administered orally intervention 2: PEG 180 μg administered via subcutaneous (s.c.) injection once weekly intervention 3: RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)

Protocol document: