A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

NCT ID: NCT05690711

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-07
• Study Completion Date: 2024-02-27

Brief Summary

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.

Conditions

Brain Swelling, Large Hemispheric Infarction

Study Design

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

Study Groups

HRS8179

Group Type: EXPERIMENTAL

HRS8179

Intervention Type: DRUG

HRS8179 injection

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

physiological saline

Interventions

HRS8179

HRS8179 injection

Intervention Type: DRUG

Placebo

physiological saline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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);

2. Aged 18~80, regardless of gender;

3. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;

4. NIHSS ≥ 10 points at screening;

5. 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).

6. The study drug initiated must be no later than 10 hours when stroke onset;

Exclusion Criteria

1. The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere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;

2. CT/MRI suggested that the anterior septal/pineal excursion was >2 mm due to brain edema;

3. CT/MRI indicates cerebral hemorrhage (excluding small ecchymosis/punctate 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

Countries

China

Other Identifiers

HRS8179-201

Identifier Type: -

Identifier Source: org_study_id