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

August 18, 2025 updated by: Beijing Suncadia Pharmaceuticals Co., Ltd

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

725

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Principal Investigator:
          • Liping Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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);
  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 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography 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 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 hemisphere sufficiently serious to affect functional outcome.
  3. There are clinical signs of brain herniation; CT/MRI indicates a midline shift of >2 mm; CT/MRI indicates cerebral hemorrhage;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group A: HRS8179 injection
Drug: HRS8179 injection
HRS8179 injection; high dose
Experimental: Treatment group B: HRS8179 injection
Drug: HRS8179 injection
HRS8179 injection; high dose
Placebo Comparator: Treatment group C: HRS8179 blank preparation.
Drug: HRS8179 blank preparation.
HRS8179 blank preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality rate at Day 90
Time Frame: at Day 90
at Day 90

Secondary Outcome Measures

Outcome Measure
Time Frame
The modified Rankin Scale (mRS) score at Day 90
Time Frame: at Day 90
at Day 90
The proportion of participants who achieved mRS score 0-4 at Day 90
Time Frame: at Day 90
at Day 90
Changes in midline shift from baseline to 72 hours
Time Frame: from baseline to 72 hours
from baseline to 72 hours
The proportion of participants who meet the indications for decompressive craniectomy by Day 14
Time Frame: Day 14
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Actual)

December 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS8179-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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