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

Last updated: February 26, 2025
Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Overall Status: Active - Recruiting

Phase

2/3

Condition

Occlusions

Treatment

HRS8179 blank preparation.

HRS8179 injection

Clinical Study ID

NCT06732648
HRS8179-301
  • Ages 18-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Fully understand and voluntarily participate in this trial, and sign the informedconsent form (the informed consent form can be signed voluntarily by the participantor 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 onmagnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computedtomography 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

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 hemispheresufficiently serious to affect functional outcome.

  3. There are clinical signs of brain herniation; CT/MRI indicates a midline shift of >2mm; CT/MRI indicates cerebral hemorrhage;

Study Design

Total Participants: 725
Treatment Group(s): 2
Primary Treatment: HRS8179 blank preparation.
Phase: 2/3
Study Start date:
February 07, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing 100000
    China

    Active - Recruiting

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