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The study is being conducted to evaluate the efficacy, and safety of HRS8179 injection in preventing and treating severe cerebral edema after large area cerebral infarction in the cerebral hemisphere
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS8179 injection | Experimental |
| |
| Treatment group B: HRS8179 injection | Experimental |
| |
| Treatment group C: HRS8179 blank preparation. | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS8179 injection | Drug | HRS8179 injection; high dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate at Day 90 | at Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| The modified Rankin Scale (mRS) score at Day 90 | at Day 90 | |
| The proportion of participants who achieved mRS score 0-4 at Day 90 | at Day 90 | |
| Changes in midline shift from baseline to 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Gao | Contact | 0518-82342973 | yu.gao.yg5@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| HRS8179 blank preparation. | Drug | HRS8179 blank preparation. |
|
| from baseline to 72 hours |
| The proportion of participants who meet the indications for decompressive craniectomy by Day 14 | Day 14 |