EUCTR2006-006023-39-IT进行中(未招募)不适用
Pharmacokinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
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
- All
入选标准
- •Aged =>6 years
- •Documented congenital fibrinogen deficiency
- •- Fibrinogen deficiency manifested as afibrinogemia
- •-Plasma fibrinogen activity and antigen at screening undetectable (i.e. < 20 mg/dL)
- •Informed consent signed by subject or legal guardian
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Life expectancy < 6 months
- •Bledding disorder other than congenital fibrinogen deficiency
- •Treatment with any AMP, other Haemocomplettan P, in the 4 weeks prior to enrollment
- •HIV positive
- •Polytrauma in the 2 years prior to enrollment
研究者
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