drugset / Trial / NCT00537407
A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment
RandomizedParallel-groupOpen-labelTreatment
Summary
Debio 025 (alisporivir) is an oral cyclophilin inhibitor with a new mechanism of action demonstrating potent anti-hepatitis C virus (HCV) activity in pre-clinical models and patients. The current standard of care (SOC) in HCV patients consists of a combination of peg-IFN alpha and ribavirin. Treatment duration and ribavirin dose depend on the genotype treated. Only 40-50% of patients with genotype 1 achieve a sustained viral response (SVR). This study assesses whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin can improve the outcome of treatment in this group of patients.
Timeline
- Start
- 2007-09
- Primary completion
- 2010-04
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alisporivir | Protein / enzyme biologic | 400 mg | Oral |
| Subject | Alisporivir | Protein / enzyme biologic | 800 mg | Oral |
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Subject | Ribavirin | Small molecule | 1000 mg | Oral |
| Subject | Ribavirin | Small molecule | 1200 mg | Oral |