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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHB-137 and placebo | Experimental |
| |
| AHB-137 and Nucleos(t)Ide Analogue (NAs) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHB-137 | Drug | AHB-137 will be administered . |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving functional cure during 24 weeks after discontinuation of all CHB therapy. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 401336 | China | ||
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C015378 | nas |
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| NAs | Drug | NAs will be administered. |
|
| Placebo | Drug | Placebo will be administered . |
|
| Up to 48 weeks |
| Number of participants with HBV DNA<LLOQ and the percentage of participants with different HBV DNA reduction. | Up to 48 weeks |
| Proportion of participants achieving HBsAg<LOD and HBV DNA<LLOQ, with or without HBsAb | Up to 48 weeks |
| Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb | 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. | Up to 48 weeks |
| Percentage of participants who reached HBeAg negative | Only for participants with HBeAg positive at baseline | Up to 48 weeks |
| Percentage of participants achieving HBeAg seroconversion | Only for participants with HBeAg positive at baseline | Up to 48 weeks |
| Proportion of participants with ALT normailzation in absence of rescue therapy. | Only for participants with abnormal ALT at baseline | Up to 48 weeks |
| Time of ALT normalization in absence of rescue therapy | Only for participants with abnormal ALT at baseline | 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 | Up to 48 weeks |
| Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA) | Up to 48 weeks |
| The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma | Up to 48 weeks |
| The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137 | Up to 48 weeks |
| Plasma concentrations of AHB-137 | Up to 48 weeks |
| Mengchao Hepatobiliary Hospital of Fujian Medical University |
| Fuzhou |
| Fujian |
| China |
| The Third People's Hospital of Zhenjiang | Zhenjiang | Jiangsu | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310052 | China |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |