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

NCT ID: NCT06732648

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 725 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-07
• Study Completion Date: 2027-09-30

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

Conditions

Severe Cerebral Edema Following Large Hemispheric Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group A: HRS8179 injection

Group Type: EXPERIMENTAL

HRS8179 injection

Intervention Type: DRUG

HRS8179 injection; high dose

Treatment group B: HRS8179 injection

Group Type: EXPERIMENTAL

HRS8179 injection

Intervention Type: DRUG

HRS8179 injection; high dose

Treatment group C: HRS8179 blank preparation.

Group Type: PLACEBO_COMPARATOR

HRS8179 blank preparation.

Intervention Type: DRUG

HRS8179 blank preparation.

Interventions

HRS8179 injection

HRS8179 injection; high dose

Intervention Type: DRUG

HRS8179 blank preparation.

HRS8179 blank preparation.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Suncadia Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Gao

Role: CONTACT

yu.gao.yg5@hengrui.com

0518-82342973

Other Identifiers

HRS8179-301

Identifier Type: -

Identifier Source: org_study_id