EUCTR2018-004889-34-FR进行中（未招募）1 期
Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B with inhibitors - explorer7
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 133
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
- •- 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 or older years at the time of signing informed consent
- •- Congenital Haemophilia A or B of any severity with documented history of inhibitor (0.6 BU or more)
- •- Patient has been prescribed, or in need of, treatment with bypassing agents in the last 24 weeks prior to screening (for patients not previously enrolled in NN7415-4310)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 108
- •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
- •- Ongoing or planned Immune Tolerance Induction treatment
研究者
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