drugset / Trial / NCT01970904
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis C GT 2 and 3 treatment naïve patients.
Timeline
- Start
- 2013-10
- Primary completion
- 2015-03
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alisporivir | Protein / enzyme biologic | 200 mg | Oral |
| Subject | Alisporivir | Protein / enzyme biologic | 300 mg | Oral |
| Subject | Alisporivir | Protein / enzyme biologic | 400 mg | Oral |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | — | Subcutaneous |
| Background | Ribavirin | Small molecule | 800 mg | Oral |