EUCTR2018-001631-46-NL进行中（未招募）1 期
Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease - OPTI-CLOT: To Wi
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
- All
入选标准
- •-VWD and low VWF patient of all ages, with all types of VWD and low VWF”;
- •-Undergoing a DDAVP-test, and/or
- •-Undergoing a medical intervention requiring treatment with DDAVP and/or VWF-containing concentrates with monitoring of FVIII and VWF levels. Medical interventions may include: dental, surgical or diagnostic procedures, and child deliveries in the hospital setting as examples. , or
- •-With bleeding requiring treatment with DDAVP and/or VWF-containing concentrate with monitoring of FVIII and VWF levels, or
- •-Requiring a PK profile for future medical intervention or bleeding episode, or
- •-With prescribed or requiring prophylaxis with VWF-containing concentrate due to bleeding frequency.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 68
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Any other known hemostatic abnormalities;
- •- Acquired VWD;
- •- Presence of VWF antibodies (>0.2 BU)
- •- Withdrawal of (parental) informed consent.
研究者
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