研究单位:[1]Beijing Kawin Technology Share-Holding Co., Ltd.[2]The First Affiliated Hospital of Fujian Medical University[3]First Affiliated Hospital of Lanzhou University[4]Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology
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.