Conditions: Hepatitis C
Keywords: Chronic hepatitis C Cyclophilin inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1081
Healthy volunteers: no

Brief summary:
This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

Detailed description:

Arms:
arm 1: Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT):

* Participants with a viral load below the level of detection (\< LOD) at Week 4 stop study treatment after 24 weeks
* Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment arm 2: Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT) arm 3: Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks arm 4: ALV Placebo with PEG and RBV for 48 weeks

Interventions: intervention 1: Alisporivir intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin intervention 4: ALV Placebo
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 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose intervention 4: ALV placebo soft gel capsules administered orally

Protocol document: