The Efficacy and Safety of HRS8179 in Severe Cerebral Edema Following Large Hemispheric Infarction
Recruiting now · Phase 2/Phase 3
Conditions studied: Severe Cerebral Edema Following Large Hemispheric Infarction
In brief
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
Key facts
- Study ID
- NCT06732648
- Run by
- Beijing Suncadia Pharmaceuticals Co., Ltd
- People needed
- 725
- Starts
- 2025-02-07
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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);
- A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
- National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening;
- 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).
- 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.
You may not qualify if…
- Theparticipant is likely to withdraw the supportive treatment on the first day;
- There is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.
- There are clinical signs of brain herniation; CT/MRI indicates a midline shift of >2 mm; CT/MRI indicates cerebral hemorrhage;
Where it is running
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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