EUCTR2013-002686-19-IT进行中（未招募）不适用
Hemophilia Inhibitor PUP Study - HIPS
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano0 个研究点目标入组 50 人开始时间: 2013年7月4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
- 50
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
- •The principal inclusion criteria are:
- •1) An informed consent, approved by the appropriate Institutional
- •Review Board(IRB)/Independent Ethics Committee (IEC) has been
- •administered, signed and dated by the parents or legal rapresentative
- •of the patients
- •2) Subject diagnosed with severe haemophilia A defined by a baseline
- •FVIII:C < 0,01 IU/mL. The FVIII activity has to be confirmed by a central lab. If the confirmatory level is not < 0,01 IU/mL the child
- •must exit the study
- •3) Subject weights 3,5 kg or more at the time of his baseline study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •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 principal exclusion criteria are:
- •1) Subjects with prior exposure to clotting factor concentrates or blood
- •2) Subjects with a clinically significant chronic disease other than
- •hemophilia A.
- •3) Subjects that are currently partecipating to other investigational
- •clinical trials
研究者
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