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A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

Primary Purpose

Brain Swelling, Large Hemispheric Infarction

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HRS8179
Placebo
Sponsored by
Beijing Suncadia Pharmaceuticals Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Swelling, Large Hemispheric Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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must be no later than 10 hours when stroke onset; Exclusion Criteria: The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere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);

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    HRS8179

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    modified Rankin Scale (mRS) Score
    Overall survival
    Number of Participants Who Achieved mRS 0-4
    Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Full Information

    First Posted
    December 27, 2022
    Last Updated
    January 17, 2023
    Sponsor
    Beijing Suncadia Pharmaceuticals Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05690711
    Brief Title
    A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction
    Official Title
    Efficacy and Safety of Intravenous HRS8179 on Brain Swelling After Large Hemispheric Infarction: a Randomised, Double-blind, Placebo-controlled Phase II Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2023 (Anticipated)
    Study Completion Date
    January 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Suncadia Pharmaceuticals Co., Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Swelling, Large Hemispheric Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HRS8179
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    HRS8179
    Intervention Description
    HRS8179 injection
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    physiological saline
    Primary Outcome Measure Information:
    Title
    The change between baseline and 72-78 hours in midline shift measured by MRI or CT
    Time Frame
    Baseline up to 72 hours
    Secondary Outcome Measure Information:
    Title
    modified Rankin Scale (mRS) Score
    Time Frame
    Day 90
    Title
    Overall survival
    Time Frame
    Baseline up to Day 90
    Title
    Number of Participants Who Achieved mRS 0-4
    Time Frame
    Day 90
    Title
    Adverse Events (AEs) and Serious Adverse Events (SAEs)
    Time Frame
    Baseline up to Day 90

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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);
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pengfei Wang
    Phone
    +86 18701040733
    Email
    pengfei.wang.pw5@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

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