EUCTR2019-002641-37-NL进行中（未招募）1 期
Efficacy and safety of once-weekly subcutaneous administration of concizumab prophylaxis in patients with haemophilia A and B, with or without inhibitors - explorer9
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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 years or older at the time of signing informed consent (18 years or older for the PK/PD cohort).
- •- Diagnosis of congenital severe haemophilia A (FVIII below 1%) or moderate/severe congenital haemophilia B (FIX equal to or below 2%), or congenital haemophilia with inhibitors.
- •- Patient has been prescribed, or is in need of, treatment with coagulation factor product or bypassing agent in the last 24 weeks prior to screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •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 5
排除标准
- •- Known or suspected hypersensitivity to any constituents of the trial product.
- •- Known inherited or acquired coagulation disorder other than congenital haemophilia.
- •- Ongoing or planned Immune Tolerance Induction treatment.
研究者
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