This study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized to one of the 2 groups to receive different antiviral treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hosopital
Beijing, Beijing Municipality, China
Fuzhou Infectious Disease Hospital
Fuzhou, Fujian, China
Percentage of HBeAg seroconversion at the end of treatment
Time frame: week 48
Percentage of HBsAg undetectable and seroconversion at the end of treatment
Time frame: week 48
Percentage of HBeAg undetectable and seroconversion at week 12, 24, 36 and 48
Time frame: week 12, 24, 36 and 48
Change of HBsAg and HBeAg from baseline at week 12, 24, 36, and 48
Time frame: week 12, 24, 36, and 48
Change of HBV DNA from baseline and percentage of HBV DNA undetectable at week 12, 24, 36, and 48
Time frame: treatment week 12, 24, 36, and 48
Percentage of ALT normalization at week 24, 36 and 48
Time frame: week 24 ,36 and 48
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Xiamen Hospital of T.C.M
Xiamen, Fujian, China
Nanfang Hospital
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital, Huazhong University of Science & Technology
Wuhan, Hubei, China
Xiangya Second Hospital, Central-south University
Changsha, Hunan, China
Shenyang Sixed People's Hospital
Shenyang, Liaoning, China
Ruijing Hospital
Shanghai, Shanghai Municipality, China
...and 2 more locations