A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

Phase 2

Completed

• Conditions: Brain Swelling, Large Hemispheric Infarction
• Interventions: Drug: Placebo; Drug: HRS8179

• Registration Number: NCT05690711
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-19
• Study Start: 2023-04-07
• Primary Completion: 2023-12-05
• Study Completion: 2024-02-27
• Status Verified: 2024-05
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
HRS8179	HRS8179	-

Primary Outcome Measures

Name	Time	Method
The change between baseline and 72-78 hours in midline shift measured by MRI or CT	Baseline up to 72 hours

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to Day 90
modified Rankin Scale (mRS) Score	Day 90
Overall survival	Baseline up to Day 90
Number of Participants Who Achieved mRS 0-4	Day 90

Trial Locations

Locations (1)

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