The experiment is divided into two parts: Part 1 and Part 2.Part 1 was the initial treatment patient and Part 2 was the treated patient.
About 125 subjects were planned to be included and assigned to the experimental group and the control group according to 4:1.At the same time, a liver biopsy group was set up in each part of the population to receive liver biopsy during the screening period and 48 weeks after completion of drug administration, which was used to detect HBV DNA, cccDNA, HBsAg, and evaluate the degree of liver inflammation and fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
The value of serum HBsAg decreased from baseline
The value of serum HBsAg at 48 weeks of treatment was lowered compared with baseline.
Time frame: 48 weeks after dosing
The value of serum HBeAg decreased from baseline
The value of serum HBeAg at 48 weeks of treatment was lowered compared with baseline.
Time frame: 48 weeks after dosing
The value of HBV DNA decreased from baseline
The value of HBV DNA at 48 weeks of treatment was lowered compared with baseline.
Time frame: 48 weeks after dosing
The value of serum HBsAg decreased from baseline
The value of serum HBsAg at 24 weeks of treatment was lowered compared with baseline.
Time frame: 24 weeks after dosing
The value of serum HBeAg decreased from baseline
The value of serum HBeAg at 24 weeks of treatment was lowered compared with baseline.
Time frame: 24 weeks after dosing
The value of HBV DNA decreased from baseline
The value of HBV DNA at 24 weeks of treatment was lowered compared with baseline.
Time frame: 24 weeks after dosing
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Beijing Ditan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing YouAn Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The second affiliated hospital of ChongQing medical university
Chongqing, Chongqing Municipality, China
The first affiliated hospital of ChongQing medical university
Chongqing, Chongqing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
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The third affiliated hospital of sun yat-sen university
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...and 27 more locations