The Efficacy and Safety of HRS8179 in Severe Cerebral Edema Following Large Hemispheric Infarction

Beijing Suncadia Pharmaceuticals

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Severe Cerebral Edema Following Large Hemispheric Infarction

Treatments: Drug: HRS8179 injection; Drug: HRS8179 blank preparation.

Study type: Interventional

Funder types: Industry

Identifiers

NCT06732648

HRS8179-301

Details and patient eligibility

About

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

Enrollment: 725 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative);
2. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
3. National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening;
4. A large hemispheric infarction defined as: lesion volume of 80 to 160 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP).
5. The time from onset to treatment must be ≤ 10 hours; if the onset time is unknown, treatment must be initiated within 10 hours after the time last known normal.

Exclusion criteria

1. Theparticipant is likely to withdraw the supportive treatment on the first day;
2. There is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.
3. There are clinical signs of brain herniation; CT/MRI indicates a midline shift of >2 mm; CT/MRI indicates cerebral hemorrhage;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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725 participants in 3 patient groups, including a placebo group

Treatment group A: HRS8179 injection

Experimental group

Treatment:

Drug: HRS8179 injection

Treatment group B: HRS8179 injection

Experimental group

Treatment:

Drug: HRS8179 injection

Treatment group C: HRS8179 blank preparation.

Placebo Comparator group

Treatment:

Drug: HRS8179 blank preparation.