This is an open-label, multicenter, Phase 2 study designed to evaluate the efficacy and safety of AHB-137 injection in participants with chronic hepatitis B (CHB) with low hepatitis B surface antigen (HBsAg) levels.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
AHB-137 will be injected
NA will be usede.
AusperBio Investigational Site
Beijing, Beijing Municipality, China
RECRUITINGAusperBio Investigational Site
Jilin City, Changchun, China
RECRUITINGProportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.
Time frame: At the 24th week after all treatment for CHB was discontinued
Proportion of participants with persistent HBV DNA < LLOQ .
Time frame: During the 24-week period after discontinuation of all CHB treatment
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ).
Time frame: Up to 60 weeks
Detection of the concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.
Time frame: Up to 60 weeks
Relapse rate and time after discontinuation of NAs therapy.
Time frame: Up to 60 weeks
Changes of the score of Health-Related Quality of Life (HBQOL) in participants compared with baseline.
Time frame: Up to 60 weeks
Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.
Time frame: Up to 60 weeks
Number and percentage of participants with detectable anti-drug antibodies (ADA).
Time frame: Up to 60 weeks
Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance in the target region of AHB-137.
Time frame: Up to 60 weeks
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AusperBio Investigational Site
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGAusperBio Investigational Site
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGAusperBio Investigational Site
Xiamen, Fujian, China
RECRUITINGAusperBio Investigational Site
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGAusperBio Investigational Site
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGAusperBio Investigational Site
Nanning, Guangxi, China
RECRUITINGAusperBio Investigational Site
Zhengzhou, Henan, China
NOT_YET_RECRUITINGAusperBio Investigational Site
Changzhou, Jiangsu, China
NOT_YET_RECRUITING...and 2 more locations
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Examination including laboratory examination, electrocardiogram (ECG) examination.
Time frame: Up to 60 weeks
Plasma concentrations of AHB-137.
Time frame: Up to 60 weeks