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Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C

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研究单位: [1]Xiamen Amoytop Biotech Co., Ltd. [2]Tongji Hospital, Huazhong University of Science&Technology Wuhan, China [3]Peking University People's Hospital

关键词: HCV CHC Hepatitis C Chronic Liver Diseases Hepatitis Viral Human Hepadnaviridae Infections Antiviral Agents Virus Diseases Peginterferon alfa

研究目的:
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients, with Pegasys 180mcg/week & Ribavirin as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory requirements.

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