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A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-5635 Injection dose 1 | Experimental |
| |
| HRS-5635 Injection dose 2 | Experimental |
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| HRS-5635 Injection dose 3 | Experimental |
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| HRS-5635 Injection dose 4 | Experimental |
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| HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection | Experimental |
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| HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection | Experimental |
| |
| Peg-IFN-α, administered by subcutaneous injection | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5635 Injection | Drug | HRS-5635 Injection low dose administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| PartA:Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12 | Week 12 | |
| PartB:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 | Week 48 | |
| PartC:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 | Week 48 | |
| PartD:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in mean log10 serum hepatitis B surface antigen levels | Pre-specified time points up to 72 weeks | |
| Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen | Pre-specified time points up to 72 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaopeng Wang | Contact | 0518-82342973 | xiaopeng.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital | Recruiting | Guangzhou | Guangdong | 510515 | China |
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Multi-center, random, open, parallel design
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| HRS-5635 Injection with Peg-IFN-α(Part C) | Experimental |
|
| HRS-5635 Injection(Part D) | Experimental |
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| HRS-5635 Injection | Drug | HRS-5635 Injection medium dose administered by subcutaneous injection |
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| HRS-5635 Injection | Drug | HRS-5635 Injection high dose administered by subcutaneous injection |
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| HRS-5635 Injection | Drug | HRS-5635 Injection lowest dose administered by subcutaneous injection |
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| HRS-5635 Injection (low dose) and Peg-IFN-α | Drug | HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection |
|
| HRS-5635 Injection (high dose) and Peg-IFN-α | Drug | HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection |
|
| Peg-IFN-α | Drug | Peg-IFN-α, administered by subcutaneous injection |
|
| HRS-5635 Injection with Peg-IFN-α | Drug | HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection |
|
| HRS-5635 Injection | Drug | HRS-5635 Injection, administered by subcutaneous injection |
|
| Proportion of subjects with serum hepatitis B surface antigen loss | Pre-specified time points up to 72 weeks |
| Proportion of subjects with serum hepatitis B surface antigen seroconversion | Pre-specified time points up to 72 weeks |
| Proportion of subjects with hepatitis B e-antigen loss | Pre-specified time points up to 72 weeks |
| Proportion of subjects with serum hepatitis B e-antigen seroconversion | Pre-specified time points up to 72 weeks |
| Proportion of subjects with virologic breakthrough | Pre-specified time points up to 72 weeks |
| Proportion of subjects with drug resistance | Pre-specified time points up to 72 weeks |
| Proportion of subjects who meet the criteria for stopping NA therapy | From 48 weeks to 72 weeks |
| Proportion of subjects with serum hepatitis B surface antigen loss and HBV DNA loss | 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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