drugset / Trial / NCT01908335
A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C
RandomizedParallel-groupOpen-labelTreatment
Summary
This dose-escalating study is to evaluate the efficacy and the safety of different doses 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(IFN) by exploring the dose-effect relationship, while identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method is adopted to assess the pharmacokinetic behavior, individuals / intra-individual variability, and the possible factors for further study.
Timeline
- Start
- 2012-10
- Primary completion
- 2013-08
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEG-IFN-SA | Protein / enzyme biologic | 0.75 ug/kg | — |
| Subject | PEG-IFN-SA | Protein / enzyme biologic | 1.5 ug/kg | — |
| Subject | PEG-IFN-SA | Protein / enzyme biologic | 2 ug/kg | — |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | — |
| Comparator | Ribavirin | Small molecule | 1000 mg | — |
| Comparator | Ribavirin | Small molecule | 1200 mg | — |