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This study is an open-label, multicenter phase II clinical study to evaluate the efficacy and safety of AHB-137 injection in participants with CHB previously treated with NA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relevant drug treatment group | Experimental |
| |
| No relevant drug treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHB-137 | Drug | AHB-137 will be injected |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion 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. | At the 24th week after all treatment for CHB was discontinued |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with persistent HBV DNA < LLOQ . | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu | Contact | 0571-86959519 | clinicaltrial@ausperbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Junqi Niu | The First Hospital of Jilin University | Principal Investigator |
| Yanhua Ding | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AusperBio Investigational Site | Recruiting | Jilin City | Changchun | 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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| Up to 60 weeks |
| Detection of the concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg. | Up to 60 weeks |
| Relapse rate and time after discontinuation of NAs therapy. | Up to 60 weeks |
| Changes of the score of Health-Related Quality of Life (HBQOL) in participants compared with baseline. | Up to 60 weeks |
| Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline. | Up to 60 weeks |
| Number and percentage of participants with detectable anti-drug antibodies (ADA). | 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. | Up to 60 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. | Up to 60 weeks |
| Plasma concentrations of AHB-137. | Up to 60 weeks |
| 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 |