EUCTR2012-001669-34-AT进行中（未招募）不适用
Genetic Influence on the Pharmacokinetic Behavor of Factor VIII - FVIII PK Study
Med. Univ. Wien, Univ. Klinik f. Kinder- u. Jugendheilkunde, Klin. Abt.f. Pädiatrische Kardiologie0 个研究点目标入组 100 人开始时间: 2012年6月6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）
- 发起方
- 入组人数
- 100
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
- •This analysis will be performed on a study cohort of approximately 100 severe hemophilia A boys.The boys will be aged between 6 and 18 years and will have severe FVIII deficiency (baseline levels <1%). Only patients using recombinant FVIII products will be included. Following the acquisition of written informed consent the following investigations will be performed on the study participants
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The analysis of factor VIII clearance must be performed at a time when there is no bleeding (bleeding will use up the factor VIII and therefore shorten its circulation time). In addition, there should be no factor VIII antibodies (factor VIII inhibitors) present at the time of testing.
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