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CompletedNCT05690711Updated Jan 6, 2025

A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

A Phase 2 interventional study of HRS8179 and Placebo in Brain Swelling, Large Hemispheric Infarction, sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Swelling, Large Hemispheric Infarction

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03

In context

Brain Edema

102 studies on the registry are indexed under Brain Edema; 25 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 62 interventional studies indexed under Brain Edema.

Browse Brain Edema studies →

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd is the lead sponsor of 25 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Fully understand and voluntarily participate in this research, and sign the 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

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);
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    HRS8179

    Drug: HRS8179

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugHRS8179

    HRS8179 injection

  • DrugPlacebo

    physiological saline

06

What researchers measure

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

07

Study locations

1 site
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing 100050, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05690711
Responsible party
Sponsor
First posted
Jan 19, 2023
Start date
Apr 7, 2023
Primary completion
Dec 5, 2023
Completion
Feb 27, 2024
Last update
Jan 6, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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