NCT01145859已完成1 期
Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 59
- 主要终点
- Pharmacokinetics parameters (AUC and Cmax)
研究概览
简要总结
The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric subjects > 6 months and < 18 years of age at the time of administration of study drug.
- •Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE
排除标准
- •Any major or clinically relevant bleeding during prior VTE treatment
- •Abnormal coagulation tests within 7 days prior to study drug administration
- •Severe renal impairment
- •Planned invasive procedures prior to or after 24 hours of study drug administration
研究组 & 干预措施
Arm 1
Experimental
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Pharmacokinetics parameters (AUC and Cmax)
时间窗: From Day 1 to Day 2
Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)
时间窗: From Day 1 to Day 2
次要结局
- Safety and tolerability of rivaroxaban in pediatric subjects(Day 1, day 2 plus 7 days follow up)
研究者
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