EUCTR2018-004891-36-ES进行中(未招募)1 期
Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B without inhibitors - explorer8
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 150
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
入选标准
- •- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •- Male aged 12 years or older at the time of signing informed consent.
- •- Congenital severe haemophilia A (FVIII less than 1%) or B (FIX 2% or less)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 35
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Known or suspected hypersensitivity to monoclonal antibodies
- •- Known inherited or acquired coagulation disorder other than congenital haemophilia
- •- Presence of confirmed inhibitors 0.6 BU or greater at screening
研究者
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