The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and follow-up phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
AusperBio Investigational Site
Guangzhou, Guangdong, China
AusperBio Investigational Site
Changzhou, Jiangsu, China
Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ).
Time frame: Up to 24 weeks
Proportion of participants achieving functional cure during 24 weeks after discontinuation of all CHB therapy.
Time frame: Up to 48 weeks
Number of Participants With HBsAg<LOD (0.05 IU/mL) and the percentage of participants with different levels of HBsAg reduction compared with baseline.
Time frame: Up to 48 weeks
Number of participants with HBV DNA<LLOQ and the percentage of participants with different HBV DNA reduction.
Time frame: Up to 48 weeks
Proportion of participants achieving HBsAg<LOD and HBV DNA<LLOQ, with or without HBsAb
Time frame: Up to 48 weeks
Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb
Time frame: Up to 48weeks
Changes of the score of hepatitis B quality of life instrument (HBQOL) compared with baseline
This scale has 31 items, including 7 dimensions: psychological status, expected anxiety, vitality, shame, infectivity, health vulnerability, and viral response. Each item is scored on a 5-point scale, with higher scores indicating a more severe impact of hepatitis B on quality of life.
Time frame: Up to 48 weeks
Percentage of participants who reached HBeAg negative
Only for participants with HBeAg positive at baseline
Time frame: Up to 48 weeks
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The Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Percentage of participants achieving HBeAg seroconversion
Only for participants with HBeAg positive at baseline
Time frame: Up to 48 weeks
Proportion of participants with ALT normailzation in absence of rescue therapy.
Only for participants with abnormal ALT at baseline
Time frame: Up to 48 weeks
Time of ALT normalization in absence of rescue therapy
Only for participants with abnormal ALT at baseline
Time frame: Up to 48 weeks
Safety: number of participants with treatment-emergent adverse events (TEAEs), treatment-related adverse events(TRAEs), serious adverse events (SAE) and clinically significant examination results
Examination including laboratory examination, electrocardiogram (ECG) examination
Time frame: Up to 48 weeks
Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA)
Time frame: Up to 48 weeks
The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma
Time frame: Up to 48 weeks
The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137
Time frame: Up to 48 weeks
Plasma concentrations of AHB-137
Time frame: Up to 48 weeks