CTRI/2014/07/004749已完成4 期
Immune Tolerance Induction, by Factor VIII concentrate containing von Willebrand factor, in severe or moderate haemophilia A patients with inhibitors.
Sintesi Research0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Subjects (his/her parent/legal representative), must have given a written informed consent
- •2.Male children: age <12 years
- •3.Severe or moderate hemophilia A (FVIII <2%)
- •4.High responders (clinical history of inhibitor peak > 5BU)
- •Or low-responders with potential bleedings, assessed by responsible physicians as not to be treated with high FVIII doses.
- •5.Any level of inhibitor at study enrollment.
- •6.Willingness and ability to participate in the study.
- •7.No other experimental treatments
排除标准
- •1.Any clinically relevant abnormality, in hematological, biochemical and urinary routine examinations, or any condition or treatment which in the investigatorâ??s opinion, makes the patient not eligible for the study.
- •2.Intolerance to active substance or to any of the excipients of FVIII / VWF concentrate.
- •3.Concomitant systemic treatment with immunosuppressive drugs.
研究者
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