NL-OMON39820已完成不适用
Hemophilia Inhibitor PUP Study - HIPS
niversity of Texas Health Science Center0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •1. An informed consent, approved by the appropriate Institutional Review Board (IRB)/Independent Ethics Committee (IEC), has been administered, signed, and dated.
- •2. Subject has severe hemophilia A defined by a baseline FVIII:C <0.01 IU/ml. His FVIII activity will be confirmed at the central laboratory. If the confirmatory level is >=0.01 IU/ml the child must exit the study.
- •3. Subject weighs 3.5 kg or more at the time of his baseline study evaluation
排除标准
- •1. Subject has had prior exposure to clotting factor concentrates or blood products, including packed red blood cells (RBC), platelets, plasma, or cryoprecipitate.
- •2. Subject has a clinically significant chronic disease other than hemophilia A.
- •3. Subject is currently participating in another investigational drug study.
研究者
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