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NCT Number: NCT06732648

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

Liping Liu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

HRS8179 injection

Drug

HRS8179 injection; high dose

HRS8179 blank preparation.

Drug

HRS8179 blank preparation.

Primary outcomes

  1. Mortality rate at Day 90

    Time frame: at Day 90

Secondary outcomes

  1. The modified Rankin Scale (mRS) score at Day 90

    Time frame: at Day 90

  2. The proportion of participants who achieved mRS score 0-4 at Day 90

    Time frame: at Day 90

  3. Changes in midline shift from baseline to 72 hours

    Time frame: from baseline to 72 hours

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

    Time frame: Day 14

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study title

The Efficacy and Safety of Intravenous HRS8179 for the Prevention and Treatment of Severe Cerebral Edema Following Large Hemispheric Infarction: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II/III Clinical Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2024
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.