EUCTR2009-013618-29-SK进行中（未招募）1 期
Open-label safety and tolerability of dabigatran etexilate mesilate given for 3 days at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years, and 1 year to less than 2 years.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- •1) Males or females 1 to < 12 years of age
- •2) Objective diagnosis of VTE
- •3) End of planned treatment course with low molecular weight heparin (LMWH) or oral anticoagulant (OAC) for VTE with INR and aPTT both within normal limits.
- •4) Written informed consent provided by the patient’s parent (or legal guardian) and assent provided by the patient (if applicable) at the time of ICF signature.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 16
- •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
- •1) conditions associated with increased risk of bleeding
- •2) severe renal dysfunction or requirement for dialysis
- •3) active infective endocarditis
- •4) hepatic disease
- •5) anemia or thrombocytopenia
- •6) use of prohibited or restricted drug within previous week
- •7) pregnant females or females not using medically accepted contraceptive method
- •8) received investigational drug within past 30 days
- •9) unreliable patients or patients who have any condition that would not allow safe participation in study
研究者
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