drugset / Trial / NCT01903278
Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is to confirm the potential effects and assess the safety of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated with Interferon.
Timeline
- Start
- 2013-06
- Primary completion
- 2015-08
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEG-IFN-SA | Protein / enzyme biologic | 1.5 ug/kg | Intramuscular |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | — |
| Background | Ribavirin | Small molecule | 1000 mg | Oral |
| Background | Ribavirin | Small molecule | 1200 mg | Oral |