This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
820
sc, qw, 48 weeks.
sc, qw, 48 weeks.
Proportion of patients with HBeAg seroconversion at week72
Time frame: 24 weeks after the cessation of treatment
Proportion of Patients with HBeAg seroconversion at week 12,24,48
Time frame: week 12, 24, 48 from treatment starting
Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72.
Time frame: week 4, 12, 24, 48 and 72 from treatment starting
Average of HBV DNA decline level at week 12, 24,48 and 72
Time frame: week 12, 24, 48 and 72 from treatment starting
Average of HBsAg decline level at week 12, 24, 48 and 72, and Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 12, 24, 48 and 72.
Time frame: week 12, 24, 48 and 72 from treatment starting
Proportion of patients with ALT normalization at week 12,24, 48 and 72.
Time frame: week 12, 24, 48 and 72 from treatment starting
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Xiamen Hospital of T.C.M
Xiamen, Fujian, China
Beijing University Shenzhen Hospital
Shenzhen, Guangdong, China
302 Military Hospital
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Beijing Ditan Hospital Capital Medical University
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Beijing Youan Hospital, Capital Medical University
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Beijing Youyi Hospital, Capital Medical University
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
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First Affiliated Hospital of Jilin University
Changchun, China
Xiangya Hospital, Central-south University
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...and 33 more locations