This study is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
AHB-137 300 mg will be injected subcutaneously once a week (total 24 weeks).
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Proportion of participants with serum HBsAg < limit of detection (LOD) 0.05 international unit per milliliter (IU/mL) and Hepatitis B Virus (HBV) DNA < lower limit of quantification (LLOQ) with or without HBsAb seroconversion.
Time frame: Up to 24 weeks
Number and percentage of participants with serum HBsAg < LOD and/or HBV DNA < LLOQ.
Time frame: Up to 72 weeks
Proportion of participants maintaining sustained response;
Time frame: Up to 48 weeks
The changes of liver HBsAg, HBcAg, HBV RNA, integration HBV DNA and covalently closed circular DNA (cccDNA) compared to baseline;
Time frame: Up to 72 weeks
The changes in the phenotype of liver immune cells compared to baseline;
Time frame: Up to 72 weeks
The changes of peripheral blood cytokines compared to baseline;
Time frame: Up to 72 weeks
The changes of peripheral blood immune cell phenotypes compared to baseline;
Time frame: Up to 72 weeks
The changes of serum HBsAg, HBsAb, HBV DNA, HBV RNA, HBeAg, HBeAb compared to baseline;
Time frame: Up to 72 weeks
The changes in peripheral blood metabolomics compared to baseline;
Time frame: Up to 72 weeks
The changes in peripheral blood proteomics compared to baseline;
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Time frame: Up to 72 weeks
The changes in liver metabolomics compared to baseline, if applicable ;
Time frame: Up to 72 weeks
AHB-137 drug concentrations, and metabolite profiling, if applicable;
Time frame: Up to 72 weeks
Number and percentage of participants with detectable anti-drug antibodies (ADA);
Time frame: Up to 72 weeks
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 72 weeks
After discontinuation of all chronic hepatitis B treatments for 24 weeks, HBV DNA was below the limit of quantification (LLOQ), and HBsAg was below the detection limit (0.05 IU/mL), with HBeAg being negative, with or without the presence of HBsAg.
Time frame: Up to 72 weeks.
After discontinuation of all chronic hepatitis B treatments for 24 weeks, HBV DNA was below the limit of quantification (LLOQ), and HBsAg was less than 10 IU/mL.
Time frame: Up to 72 weeks
Whether the NA treatment discontinuation criteria have been met during the assessment of NA treatment discontinuation.
Time frame: 48 weeks