EUCTR2011-002222-46-NL进行中（未招募）1 期
In vivo effects of C1-esterase inhibitor on innate immune response during endotoxemia in human - VECTOR-II studyA randomized controlled pilot study - VECTOR II study
Radboud University Nijmegen Medical Centre0 个研究点目标入组 20 人开始时间: 2013年3月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Age = 18 and = 35 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any medication
- •Congenital or acquired C1 inhibitory deficiency
- •Immune deficiency
- •Chronic inflammatory diseases
- •History of allergic reaction to blood products
- •History, signs or symptoms of cardiovascular diseases
- •(Family) history of cerebrovasculair diseases under the age of 65 years
- •Previous vagal collaps
- •Hypertension (defined as RR systolic > 160 or RR diastolic > 90)
- •Hypotension (defined as RR systolic < 100 or RR diastolic < 50)
- •Renal impairment (defined as plasma creatinin > 120 µmol/l)
- •Liver enzyme abnormalities
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