NCT00132470已完成2 期
AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke. The primary objective of the present phase IIa study is to assess the safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke. The secondary objective is to assess the effect of AX200 on subject outcome in comparison to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke onset within 12 hours prior to start of study agent administration
- •Ischemic stroke in the middle cerebral artery (MCA) territory confirmed by magnetic resonance imaging (MRI)
排除标准
- •Time interval since stroke onset impossible to determine
- •Carotid T-occlusion (magnetic resonance angiography [MRA])
- •Subarachnoid hemorrhages
- •Several safety parameters
结局指标
主要结局
Safety
次要结局
- Neurological outcome
- ischemic lesion growth
研究者
研究点 (4)
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