Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 80Years
All Genders
NCT06732648

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

Led by Beijing Suncadia Pharmaceuticals Co., Ltd · Updated on 2025-08-22

725

Participants Needed

1

Research Sites

133 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fully understand and voluntarily participate in this trial, and sign the informed consent form (participant or legal representative may sign)
  • Clinical diagnosis of acute ischemic stroke in the middle cerebral artery territory
  • National Institutes of Health Stroke Scale (NIHSS) score of 10 or higher at screening
  • Large hemispheric infarction with lesion volume 80 to 160 cm3 on MRI diffusion-weighted imaging or CT perfusion
  • Treatment started within 10 hours of stroke onset or last known normal time
Not Eligible

You will not qualify if you...

  • Likely to withdraw supportive treatment on the first day
  • Evidence of a serious infarction in the opposite hemisphere affecting function
  • Clinical signs of brain herniation
  • CT/MRI shows a midline shift greater than 2 mm
  • CT/MRI shows cerebral hemorrhage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100000

Actively Recruiting

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Research Team

Y

Yu Gao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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