研究单位：[1]Xiamen Amoytop Biotech Co., Ltd.[2]Tongji Hospital, Huazhong University of Science&Technology Wuhan, China[3]Tangdu Hospital, Fourth Military Medical University Xian, China[4]First Affiliated Hospital of Zhengzhou University Zhengzhou, China[5]Henan Provincial People's Hospital Zhengzhou, China[6]First Affiliated Hospital of Wenzhou Medical College Wenzhou, China[7]Tianjin Third Central Hospital Tianjin, China[8]First Affiliated Hospital, Shanxi University Taiyuan, China[9]Third Affiliated Hospital, Hebei Medical University Shijiazhuang, China[10]Shenzhen Third People's Hospital Shenzhen, China[11]Shanghai Public Health Clinical Center Shanghai, China[12]Ruijin Hospital Shanghai, China[13]Renji Hospital Shanghai, China[14]Huashan Hospital Shanghai, China[15]Changhai Hospital Shanghai, China[16]85 Militay Hospital Shanghai, China[17]Second Hospital of Nanjing Nanjing, China[18]Jiangsu Province Hospital Nanjing, China[19]81 Military Hospital Nanjing, China[20]First Affiliated Hospital of Nanchang University Nanchang, China[21]First Affiliated Hospital of Lanzhou University Lanzhou, China
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week 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 pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.
