A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

Study Overview
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Brief Summary
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The primary objective is to explore if HRS8179 could improve midline shift at 72 hours (or at time of decompressive craniectomy or comfort measures only, if earlier) in participants with large hemispheric infarction. The secondary objective is to explore if HRS8179 could improve acute neurologic status, functional outcomes, treatment requirements and safety.

Official Title
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Efficacy and Safety of Intravenous HRS8179 on Brain Swelling After Large Hemispheric Infarction: a Randomised, Double-blind, Placebo-controlled Phase II Trial

Conditions
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Brain Swelling, Large Hemispheric Infarction

Intervention / Treatment
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* Drug: HRS8179
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fully understand and voluntarily participate in this research, and sign the informed consent form (the informed consent form can be signed voluntarily by the person or legal representative); Aged 18 80, regardless of gender; A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory; NIHSS ≥ 10 points at screening; A large hemispheric infarction is defined as: lesion volume of 80 to 300 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP). The study drug initiated must be no later than 10 hours when stroke onset; Exclusion Criteria: The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.3. There are clinical signs of brain hernia; CT/MRI suggested that the anterior septal/pineal excursion was >2 mm due to brain edema; CT/MRI indicates cerebral hemorrhage (excluding small ecchymosis/punctate hemorrhage);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRS8179<br> | Drug: HRS8179<br>* HRS8179 injection<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* physiological saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change between baseline and 72-78 hours in midline shift measured by MRI or CT |  | Baseline up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale (mRS) Score |  | Day 90 | 
| Overall survival |  | Baseline up to Day 90 | 
| Number of Participants Who Achieved mRS 0-4 |  | Day 90 | 
| Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Baseline up to Day 90 |