NCT00927836已完成2 期
AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 56
- 主要终点
- Improvement on mRS relative to placebo-treated patients
研究概览
简要总结
The purpose of this study is to assess the efficacy of AX200 (filgrastim) in the treatment of acute ischemic stroke and to assess the safety and tolerability of AX200.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of acute ischemic stroke with an onset within 9 hours prior to start of study agent administration
- •ischemic stroke in the MCA territory confirmed by MRI (diffusion)
- •age ≥18 years and ≤85 years
- •lesion size on DWI ≥15 ccm
- •written informed consent
排除标准
- •prior to current stroke: inability to walk or to lead an independent life
- •life expectancy less or equal 6 months
- •stupor or coma
- •lacunar infarct
- •any evidence of ICH
- •malignant hypertension
- •presence of history of active malignancies
- •platelet count <100/nl at randomization
- •leukocyte count >20/nl at randomization
- •congenital neutropenia
- •pregnant or lactating women
研究组 & 干预措施
AX200
Experimental
干预措施: Filgrastim (Biological)
Placebo
Placebo Comparator
干预措施: Sodium chloride solution (Drug)
结局指标
主要结局
Improvement on mRS relative to placebo-treated patients
时间窗: day 90
次要结局
- Improvement on NIHSS relative to placebo-treated patients(day 90)
研究者
研究点 (56)
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