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To evaluate the efficacy and safety of HRS9950 tablets in chronic hepatitis B patients who are virologically suppressed on nucleoside or nucleotide analogues (NAs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS9950 tablets (Low dose) | Experimental |
| |
| Treatment group B: HRS9950 tablets (High dose) | Experimental |
| |
| Placebo Comparator: Treatment group C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9950 tablets | Drug | HRS9950 tablets, oral, once a week, low dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in mean log10 serum hepatitis B surface antigen levels | Pre-specified time points up to 48 weeks | |
| Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen | Pre-specified time points up to 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital | Guangzhou | Guangdong | 510515 | China |
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| HRS9950 tablets | Drug | HRS9950 tablets, oral, once a week, high dose |
|
| HRS9950 placebo tablets | Drug | HRS9950 placebo tablets, oral, once a week. |
|
| Proportion of subjects with serum hepatitis B surface antigen loss | Pre-specified time points up to 48 weeks |
| Proportion of subjects with serum hepatitis B surface antigen seroconversion | Pre-specified time points up to 48 weeks |
| Proportion of subjects with hepatitis B e-antigen loss | Pre-specified time points up to 48 weeks |
| Proportion of subjects with serum hepatitis B e-antigen seroconversion | Pre-specified time points up to 48 weeks |
| Proportion of subjects with virologic breakthrough | Pre-specified time points up to 48 weeks |
| Proportion of subjects with drug resistance | Pre-specified time points up to 48 weeks |
| 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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