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A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C

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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

关键词: interferon ribavirin virological response

研究目的:
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.

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