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临床试验/NCT00132470
NCT00132470已完成2 期

AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke

Axaron Bioscience AG4 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2004年12月1日最近更新:
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适应症
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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
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

申办方类型
Industry

研究点 (4)

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AXIS 2: AX200 for the treatment of ischemic strokeA multinational, multicenter, randomized, doubleblind,placebo-controlled, phase II trialischemic strokeMedDRA version: 9.1Level: LLTClassification code 10061256Term: Ischaemic stroke
EUCTR2008-006444-19-ATSYGNIS Bioscience GmbH & Co. KG328
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AXIS 2: AX200 for the treatment of ischemic strokeA multinational, multicenter, randomized, doubleblind,placebo-controlled, phase II trialischemic strokeMedDRA version: 9.1Level: LLTClassification code 10061256Term: Ischaemic stroke
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AXIS 2: AX200 for the treatment of ischemic strokeA multinational, multicenter, randomized, doubleblind,placebo-controlled, phase II trialischemic strokeMedDRA version: 14.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders
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AXIS 2: AX200 for the treatment of ischemic strokeA multinational, multicenter, randomized, doubleblind,placebo-controlled, phase II trialischemic strokeMedDRA version: 9.1Level: LLTClassification code 10061256Term: Ischaemic stroke
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AXIS 2: AX200 for the treatment of ischemic strokeA multinational, multicenter, randomized, doubleblind,placebo-controlled, phase II trialischemic strokeMedDRA version: 9.1Level: LLTClassification code 10061256Term: Ischaemic stroke
EUCTR2008-006444-19-SESYGNIS Bioscience GmbH & Co. KG328