跳至主要内容
临床试验/EUCTR2006-006023-39-IT
EUCTR2006-006023-39-IT进行中(未招募)不适用

Pharmacokinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency - ND

CSL Behring GmbH0 个研究点开始时间: 2007年6月12日最近更新:
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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