drugset / Trial / NCT00687219
Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)
NaSingle-groupOpen-labelTreatment
Summary
The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment will be discontinued from therapy.
Timeline
- Start
- 2007-06
- Primary completion
- 2010-10
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 1 ug/kg | Subcutaneous |
| Subject | Ribavirin | Small molecule | 400 mg | — |
| Subject | Ribavirin | Small molecule | 600 mg | — |
| Subject | Ribavirin | Small molecule | 800 mg | — |
| Subject | Ribavirin | Small molecule | 1000 mg | — |