A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

January 17, 2023 updated by: Beijing Suncadia Pharmaceuticals Co., Ltd

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

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

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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);
  2. Aged 18~80, regardless of gender;
  3. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
  4. NIHSS ≥ 10 points at screening;
  5. 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).
  6. The study drug initiated must be no later than 10 hours when stroke onset;

Exclusion Criteria:

  1. The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere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;
  2. CT/MRI suggested that the anterior septal/pineal excursion was >2 mm due to brain edema;
  3. CT/MRI indicates cerebral hemorrhage (excluding small ecchymosis/punctate 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
Placebo Comparator: Placebo
Drug: Placebo
physiological saline
Experimental: HRS8179
Drug: HRS8179
HRS8179 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change between baseline and 72-78 hours in midline shift measured by MRI or CT
Time Frame: Baseline up to 72 hours
Baseline up to 72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
modified Rankin Scale (mRS) Score
Time Frame: Day 90
Day 90
Overall survival
Time Frame: Baseline up to Day 90
Baseline up to Day 90
Number of Participants Who Achieved mRS 0-4
Time Frame: Day 90
Day 90
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to Day 90
Baseline up to Day 90

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 (Anticipated)

February 15, 2023

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

January 15, 2024

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS8179-201

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.

Clinical Trials on Brain Swelling, Large Hemispheric Infarction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe