NCT05690711已完成2 期
Efficacy and Safety of Intravenous HRS8179 on Brain Swelling After Large Hemispheric Infarction: a Randomised, Double-blind, Placebo-controlled Phase II Trial
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年4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
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change between baseline and 72-78 hours in midline shift measured by MRI or CT
研究概览
简要总结
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.
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 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;
排除标准
- •The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere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.
- •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);
研究组 & 干预措施
HRS8179
Experimental
干预措施: HRS8179 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The change between baseline and 72-78 hours in midline shift measured by MRI or CT
时间窗: Baseline up to 72 hours
次要结局
- modified Rankin Scale (mRS) Score(Day 90)
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Day 90)
- Overall survival(Baseline up to Day 90)
- Number of Participants Who Achieved mRS 0-4(Day 90)
研究者
研究点 (1)
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