NCT06732648 The Efficacy and Safety of HRS8179 in Severe Cerebral Edema Following Large Hemispheric Infarction
| NCT ID | NCT06732648 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Beijing Suncadia Pharmaceuticals Co., Ltd |
| Condition | Severe Cerebral Edema Following Large Hemispheric Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 725 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 725 participants in total. It began in 2025-02-07 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. 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); 2. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory; 3. National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening; 4. 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). 5. 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. Exclusion Criteria: 1. Theparticipant is likely to withdraw the supportive treatment on the first day; 2. There is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome. 3. There are clinical signs of brain herniation; CT/MRI indicates a midline shift of \>2 mm; CT/MRI indicates cerebral hemorrhage;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06732648 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Severe Cerebral Edema Following Large Hemispheric Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06732648 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06732648 currently recruiting?
Yes, NCT06732648 is actively recruiting participants. Contact the research team at yu.gao.yg5@hengrui.com for enrollment information.
Where is the NCT06732648 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06732648 clinical trial?
NCT06732648 is sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. The trial plans to enroll 725 participants.