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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHB-137 | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| AHB-137 (16 weeks) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHB-137 | Drug | AHB-137 injection will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving HBsAg lower than LOD and HBV DNA lower than LLOQ , regardless of whether HBsAg seroconversion is observed | At 8 weeks | |
| Proportion of participants meeting NA treatment discontinuation criteria. | Up to 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junqi Niu | The First Hospital of Jilin University | Principal Investigator |
| Jinlin Hou | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mengchao Hepatobiliary Hospital of Fujian Medical University | Fuzhou | Fujian | China | |||
| The third People's Hospital of Zhenjiang |
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| AHB-137 and Placebo |
| Drug |
AHB-137and placebo will be administered subcutaneously. |
|
| AHB-137 (16weeks) | Drug | AHB-137 injection will be administered subcutaneously. |
|
| 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 72 weeks |
| Percentage of participants with different levels of HBsAg reduction compared with baseline | Up to 72 weeks |
| Serum levels of HBV DNA, HBsAg, highly sensitive HBsAg, HBcrAg, HBV RNA, HBsAb, HBeAb and HBsAg-HBsAb. | Up to 72 weeks |
| The time from the discontinuation of NA treatment to virological relapse | Up to 72 weeks |
| The time from the discontinuation of NA treatment to clinical relapse | Up to 72 weeks |
| Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance of AHB-137 | 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 | Up to 72 weeks |
| Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA) | Up to 72 weeks |
| Changes of cytokine levels compared with baseline | Up to 72 weeks |
| The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma | Up to 72 weeks |
| The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137 | Up to 72 weeks |
| Plasma concentrations of AHB-137 | Up to 72 weeks |
| Proportion of participants maintaining sustained response. | Up to 72 weeks |
| Zhenjiang |
| Jiangsu |
| China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | China |
| Nanfang Hospital, Southern Medical University | Guangzhou | China |
| The First Hospital of Jilin University | Jilin City | China |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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