Skip to main content
OpenTrials
Completed

NCT Number: NCT05690711

A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Swelling, Large Hemispheric Infarction Brain Diseases Brain Edema Central Nervous System Diseases Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

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 research, and sign the informed consent form (the informed consent form can be signed voluntarily by the person or legal representative);
  • Aged 18~80, regardless of gender;
  • A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
  • NIHSS ≥ 10 points at screening;
  • 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).
  • The study drug initiated must be no later than 10 hours when stroke onset;

Exclusion criteria

  • The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere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;
  • CT/MRI suggested that the anterior septal/pineal excursion was >2 mm due to brain edema;
  • CT/MRI indicates cerebral hemorrhage (excluding small ecchymosis/punctate hemorrhage);

Treatment and study plan

HRS8179

Drug

HRS8179 injection

Placebo

Drug

physiological saline

Primary outcomes

  1. The change between baseline and 72-78 hours in midline shift measured by MRI or CT

    Time frame: Baseline up to 72 hours

Secondary outcomes

  1. modified Rankin Scale (mRS) Score

    Time frame: Day 90

  2. Overall survival

    Time frame: Baseline up to Day 90

  3. Number of Participants Who Achieved mRS 0-4

    Time frame: Day 90

  4. Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to Day 90

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study title

Efficacy and Safety of Intravenous HRS8179 on Brain Swelling After Large Hemispheric Infarction: a Randomised, Double-blind, Placebo-controlled Phase II Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 19, 2023
Registry last updated
Jan 6, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.