Conditions: Hepatitis C
Keywords: Hepatitis C PI treatment failure
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks

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 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Protocol document: