AB-10-8003 is a randomized, multi-center phase II study to evaluate the efficacy and safety of AHB-137 in subjects with HBeAg-negative CHB under stable NA treatment.
The study is to evaluate the efficacy and safety of AHB-137 in HBeAg-negative CHB subjects. 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
86
AHB-137 injection will be administered subcutaneously.
AHB-137and placebo will be administered subcutaneously.
AHB-137 injection will be administered subcutaneously.
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
The third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Proportion of participants achieving HBsAg < limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at the end of treatment.
Time frame: Up to 24 weeks
Proportion of participants achieving HBsAg lower than LOD and HBV DNA lower than LLOQ , regardless of whether HBsAg seroconversion is observed
Time frame: At 8 weeks
Proportion of participants meeting NA treatment discontinuation criteria.
Time frame: Up to 48 weeks
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 72 weeks
Percentage of participants with different levels of HBsAg reduction compared with baseline
Time frame: Up to 72 weeks
Serum levels of HBV DNA, HBsAg, highly sensitive HBsAg, HBcrAg, HBV RNA, HBsAb, HBeAb and HBsAg-HBsAb.
Time frame: Up to 72 weeks
The time from the discontinuation of NA treatment to virological relapse
Time frame: Up to 72 weeks
The time from the discontinuation of NA treatment to clinical relapse
Time frame: Up to 72 weeks
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Nanfang Hospital, Southern Medical University
Guangzhou, China
The First Hospital of Jilin University
Jilin, China
Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance of AHB-137
Time frame: Up to 24 weeks
Safety: number of participants with adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results, including laboratory examination, electrocardiogram (ECG) examination, physical examination and vital signs
Time frame: Up to 72 weeks
Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA)
Time frame: Up to 72 weeks
Changes of cytokine levels compared with baseline
Time frame: Up to 72 weeks
The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma
Time frame: Up to 72 weeks
The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137
Time frame: Up to 72 weeks
Plasma concentrations of AHB-137
Time frame: Up to 72 weeks
Proportion of participants maintaining sustained response.
Time frame: Up to 72 weeks