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

Phase 2

Recruiting

• Conditions: Severe Cerebral Edema Following Large Hemispheric Infarction
• Interventions: Drug: HRS8179 injection; Drug: HRS8179 blank preparation.

• Registration Number: NCT06732648
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Study Start: 2025-02-07
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2027-06
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 725

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A: HRS8179 injection	HRS8179 injection	-
Treatment group B: HRS8179 injection	HRS8179 injection	-
Treatment group C: HRS8179 blank preparation.	HRS8179 blank preparation.	-

Primary Outcome Measures

Name	Time	Method
Mortality rate at Day 90	at Day 90

Secondary Outcome Measures

Name	Time	Method
The proportion of participants who achieved mRS score 0-4 at Day 90	at Day 90
The modified Rankin Scale (mRS) score at Day 90	at Day 90
Changes in midline shift from baseline to 72 hours	from baseline to 72 hours
The proportion of participants who meet the indications for decompressive craniectomy by Day 14	Day 14

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China