Open-label Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given for 3 Days at the End of Standard Anticoagulant Therapy in Children Aged 12 Years to Less Than 18 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of Patients With Bleeding Events (Major and Minor)
研究概览
简要总结
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
dabigatran etexilate
open label; patient to receive dabigatran etexilate BID for three days
干预措施: dabigatran etexilate (Drug)
结局指标
主要结局
Number of Patients With Bleeding Events (Major and Minor)
时间窗: From Screening until 30 days after first drug administration (end of trial visit)
Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria: Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds.
Number of Patients With Adverse Events
时间窗: From Screening until 30 days after first drug administration (end of trial visit)
Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered "on-treatment" if occurring within 72 hours after last drug administration.
Plasma Concentration of Free Dabigatran
时间窗: 3 days
Plasma concentration of free dabigatran measured at 72 hours after first dose
Plasma Concentration of Total Dabigatran
时间窗: Day 3
Plasma concentration of total dabigatran measured at 72 hours after first dose
Thrombin Time (TT) Centrally Measured
时间窗: Day 3
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
TT Locally Measured
时间窗: Day 3
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
次要结局
- Activated Partial Thromboplastin Time (aPTT) Centrally Measured(Day 3)
- aPTT Locally Measured(Day 3)
- Ecarin Clotting Time (ECT)(Day 3)
- Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs(Baseline and 3 days)
- Occurences of Clinical Outcome(3 days)