drugset / Trial / NCT01309932
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.
Timeline
- Start
- 2011-03
- Primary completion
- 2014-07
- Completion
- 2014-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asunaprevir | Small molecule | 200 mg | Oral |
| Subject | Daclatasvir | Small molecule | 60 mg | Oral |
| Subject | Peginterferon Lambda-1a | Protein / enzyme biologic | 180 ug/ml | Subcutaneous |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug/ml | Subcutaneous |
| Subject | Ribavirin | Small molecule | 1000 mg | Oral |
| Subject | Ribavirin | Small molecule | 1200 mg | Oral |