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

NCT06732648 | Recruiting Phase 2

• 1 other identifier: HRS8179-301
• Study Type: interventional
• Target: 725
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mortality rate at Day 90

  at Day 90

Secondary Outcomes (4)

• 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

  from baseline to 72 hours

• The proportion of participants who meet the indications for decompressive craniectomy by Day 14

  Day 14

Study Arms (3)

Treatment group A: HRS8179 injection

EXPERIMENTAL

Drug: HRS8179 injection

Treatment group B: HRS8179 injection

EXPERIMENTAL

Drug: HRS8179 injection

Treatment group C: HRS8179 blank preparation.

PLACEBO COMPARATOR

Drug: HRS8179 blank preparation.

Interventions

HRS8179 injection DRUG

HRS8179 injection; high dose

Treatment group A: HRS8179 injection; Treatment group B: HRS8179 injection

HRS8179 blank preparation. DRUG

HRS8179 blank preparation.

Treatment group C: HRS8179 blank preparation.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
• National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening;
• 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).
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

Central Study Contacts

Yu Gao

CONTACT

0518-82342973; yu.gao.yg5@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: February 7, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2024-12

Locations

CN (1)