EUCTR2014-001259-22-AT进行中（未招募）不适用
open-label, single dose, tolerability, Pharmacokinetic/Pharmacodynamics and safety study of dabigatran etexilate given at the end of standard anticoagulant therapy in children aged less than 1 year old
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
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
- •- Neonates and infants with aged < 12 months at Visit 1
- •- Objective diagnosis of VTE
- •- End of planned treatment course with anticoagulant therapy as per standard of care at the investigator site.
- •- Written informed consent provided by the patient's parent(s) (or legal guardian) according to local regulations at Visit 1.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 8
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Weight less than 3 kg at Visit 1
- •- Conditions associated with an increased risk of bleeding
- •- renal dysfunction
- •- hepatic disease
- •- Anemia or thrombocytopenia at screening
研究者
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