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The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHB-171 in Treatment CHB | Experimental |
| |
| AHB-171 in Naïve CHB | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHB-171 Injection | Drug | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL) | Up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) | Up to 90 days | |
| Reduction of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit | Up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bella Lu | Contact | 0571-86959519 | clinicaltrial@ausperbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AusperBio Investigational Site | Jilin City | Jilin | China |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| Proportion of participants with HBsAg decline from baseline of <0.5, ≥0.5, ≥1.0, ≥1.5, ≥2.0, ≥3.0 log₁₀ IU/mL at each visi | Up to 90 days |
| Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit | Up to 90 days |
| Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit | Up to 90 days |
| Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit | Up to 90 days |
| Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit | Up to 90 days |
| Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit | Up to 90 days |
| Absolute or log change from baseline for HBsAg at each visit | Up to 90 days |
| Absolute or log change from baseline for HBV RNA at each visit | Up to 90 days |
| Absolute or log change from baseline for HBcrAg at each visit | Up to 90 days |
| Absolute or log change from baseline for HBeAg at each visit | Up to 90 days |
| Absolute or log change from baseline for HBeAb at each visit | Up to 90 days |
| Proportion of participants with baseline ALT > ULN achieving ALT normalization, and time to ALT normalization | Up to 90 days |
| Incidence and severity of treatment-emergent adverse events (TEAE) and serious adverse events (SAE) | CTCAE will be used to describe severity. | Up to 90 days |
| Proportion of participants with clinically significant abnormalities in laboratory tests | Up to 90 days |
| Proportion of participants with clinically significant abnormalities in ECG | Up to 90 days |
| Proportion of participants with clinically significant abnormalities in physical examinations and vital signs | Up to 90 days |
| Changes in ECG from baseline | Up to 90 days |
| Proportion of participants with HBsAg decline ≥2.0 log₁₀ IU/mL | Up to 90 days |
| Plasma concentration of AHB-171 at different time points | Up to 90 days |
| Proportion of participants with detectable anti-drug antibody (ADA) | Up to 90 days |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |