drugset / Trial / NCT01318694
Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
RandomizedParallel-groupDouble-blindTreatment
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)
Timeline
- Start
- 2011-03
- Primary completion
- 2013-08
- Completion
- 2013-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alisporivir | Protein / enzyme biologic | 400 mg | Oral |
| Subject | Alisporivir | Protein / enzyme biologic | 600 mg | Oral |
| Background | PEG 180 μg administered via subcutaneous (s.c.) injection once weekly | Unknown | 180 ug | Subcutaneous |
| Background | RBV 200 mg tablets (weight-based dose: \u003c 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose | Unknown | 1000 mg | — |
| Background | RBV 200 mg tablets (weight-based dose: \u003c 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose | Unknown | 1200 mg | — |