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This is a multicenter, randomized, controlled Phase IIa study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the antiviral activity and safety in subjects with with HBeAg-negative Chronic Hepatitis B treated with nucleos(t)ide reverse transcriptase inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NrtIs | Active Comparator |
| |
| HH-003 | Experimental |
| |
| HH-003+NrtIs | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NrtIs | Drug | Subjects will receive NrtIs therapy for 24 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving sustained viral response | From baseline to Week 24 | |
| Changes from baseline in serum HBsAg levels | From treatment start to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with undetectable HBV DNA in those with positive HBV DNA at baseline | From treatment start to Week 24 | |
| Proportion of participants achieving sustained viral response | From baseline to Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | China |
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| HH-003 |
| Drug |
Subjects will receive HH-003 20 mg/kg intravenously Q2W for 24 weeks. |
|
| HH-003+NrtIs | Drug | Subjects will receive HH-003 20 mg/kg intravenously Q2W for 24 weeks. Subjects will receive NrtIs therapy for 24 weeks. |
|
| Duration of sustained viral response | From treatment start to Week 48 |
| Changes from baseline in serum HBsAg levels | From treatment start up to Week 48 |
| Proportion of participants with HBV pgRNA negativation in those with positive HBV pgRNA at baseline | From baseline to Week 24 |
| Proportion of participants with normal ALT levels | From treatment start to Week 48 |
| 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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