drugset / Trial / NCT01194037
A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, randomized, safety, tolerability, dose-finding, PK/PD, and preliminary efficacy study of subcutaneous Hanferon™ in combination with ribavirin(RBV) in treatment-naïve subjects with genotype 1 hepatitis C.
Timeline
- Start
- 2011-06-23
- Primary completion
- 2011-11-28
- Completion
- 2011-11-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hanferon | Protein / enzyme biologic | 30 ug | Subcutaneous |
| Subject | Hanferon | Protein / enzyme biologic | 60 ug | Subcutaneous |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Background | Ribavirin | Small molecule | 1000 mg | Oral |
| Background | Ribavirin | Small molecule | 1200 mg | Oral |