EUCTR2008-008378-29-FR进行中（未招募）1 期
A survey on the success of inhibitor elimination using individualized concentrate selection and controlled immune tolerance induction - OBSITI
CHU de Saint-Etienne0 个研究点目标入组 200 人开始时间: 2009年4月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •- patient at any age suffering from severe (FVIII activity <= 1%), moderate (FVIII activity 1% - 5%), or mild (FVIII activity > 5%) haemophilia A with relevant inhibitor levels (> 0,6 Bethesda Unit)
- •OR who failed an earlier ITI attempt
- •- consent form signed (or parents' consent form signed)
- •- affiliated of a social regimen (or parents affiliated of a social regimen)
- •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
- •- patient with congenital or acquired bleeding defects other than haemophilia A
- •- patient with concomitant immunological diseases or receiving immunosuppressive treatement
- •- patient with a history of hypersensitivity to blood products and/or FVIII concentrates
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