NCT06732648招募中2 期
The Efficacy and Safety of Intravenous HRS8179 for the Prevention and Treatment of Severe Cerebral Edema Following Large Hemispheric Infarction: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II/III Clinical Trial
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 725 人开始时间: 2025年2月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 725
- 试验地点
- 1
- 主要终点
- Mortality rate at Day 90
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
Treatment group A: HRS8179 injection
Experimental
干预措施: HRS8179 injection (Drug)
Treatment group B: HRS8179 injection
Experimental
干预措施: HRS8179 injection (Drug)
Treatment group C: HRS8179 blank preparation.
Placebo Comparator
干预措施: HRS8179 blank preparation. (Drug)
结局指标
主要结局
Mortality rate at Day 90
时间窗: at Day 90
次要结局
- The proportion of participants who achieved mRS score 0-4 at Day 90(at Day 90)
- The modified Rankin Scale (mRS) score at Day 90(at Day 90)
- Changes in midline shift from baseline to 72 hours(from baseline to 72 hours)
- The proportion of participants who meet the indications for decompressive craniectomy by Day 14(Day 14)
研究者
研究点 (1)
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