A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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.