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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
205
sc, qw, for 48 weeks.
sc, qw, for 48 weeks.
302 Military Hospital
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
Beijing Youyi Hospital, Capital Medical University
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
First Affiliated Hospital of Jilin University
Efficacy
* Average of HBV DAN decline level at week 24. * Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.
Time frame: week 24 from treatment start
Efficacy
* Average of HBV DNA decline level at week 12, 48 and 72. * Proportion of patients with HBV DNA undetectable at week 48 and 72. * Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 48 and 72. * Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 48 and 72. * Proportion of patients with ALT normalization at week 24 and 48.
Time frame: week 12, 24, 48 from treatment start and week 24 after treatment
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Changchun, China
Xiangya Hospital, Central-south University
Changsha, China
Xiangya Second Hospital, Central-south University
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
Southwest Hospital
Chongqing, China
...and 29 more locations