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A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

Sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05690711
Collaborator
(none)
40
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Intravenous HRS8179 on Brain Swelling After Large Hemispheric Infarction: a Randomised, Double-blind, Placebo-controlled Phase II Trial
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Jan 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: HRS8179

Drug: HRS8179
HRS8179 injection
Placebo Comparator: Placebo

Drug: Placebo
physiological saline

Outcome Measures

Primary Outcome Measures

  1. The change between baseline and 72-78 hours in midline shift measured by MRI or CT [Baseline up to 72 hours]

Secondary Outcome Measures

  1. modified Rankin Scale (mRS) Score [Day 90]

  2. Overall survival [Baseline up to Day 90]

  3. Number of Participants Who Achieved mRS 0-4 [Day 90]

  4. Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Day 90]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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);

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Beijing Suncadia Pharmaceuticals Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Suncadia Pharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier:
NCT05690711
Other Study ID Numbers:
  • HRS8179-201
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 19, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Brain Edema
Infarction

Study Results

No Results Posted as of Jan 19, 2023