EUCTR2019-003427-38-HR进行中（未招募）1 期
MOdern Treatment of Inhibitor-PositiVe PATiEnts with Haemophilia A – An International Low-Interventional Pragmatic Investigator Initiated Trial - Treatment of Hemophilia A Patients With FVIII Inhibitors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •1. Participants can be of any age at the time of enrolment
- •2. Persons with HA, of any severity, who have a historical inhibitor titre = 0.6 BU/mL, including those who have failed previous ITI attempt(s)
- •3. Persons undergoing ITI with Nuwiq®, octanate® or wilate® and/or receiving prophylactic therapy with emicizumab, aPCC or rFVIIa
- •5. Participants or participants’ parent(s)/legal guardian(s) must be capable of giving signed informed consent and able to understand the trial documents
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Participants are excluded from the trial if any coagulation disorder other than HA is diagnosed
- •- Partly retrospective patients will be excluded if detailed documentation on treatment, all BEs, inhibitor titres and FVIII levels is not available for the retrospective period
研究者
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招募中
不适用
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