NCT05966740终止不适用
Safety and Effectiveness of Pradaxa Oral Pellet Formulation for Treatment of Acute Venous Thromboembolic Events (VTE) and/or for Risk Reduction of Recurrence of VTE in Pediatric Patients Aged 3 Months to Less Than 12 Years in a Real World Setting: a Prospective Non-interventional Study Conducted in the United States
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 20
- 主要终点
- Cumulative incidence of clinically relevant bleeding events
研究概览
简要总结
The main research question of this study is to obtain further safety and effectiveness data on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical practice setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 3 months to less than 12 years at the time of Pradaxa Pellets initiation
- •Written informed consent from parents/care givers and patient assent if age appropriate
- •Initiation of Pradaxa Pellets administration either as initial or subsequent therapy:
- •Treatment of VTE
- •Treatment to reduce the risk of recurrence of VTE
排除标准
- •Participation in any randomized clinical trial or use of investigational product, participation in any other observational study is not an exclusion
- •Any contraindications to Pradaxa Pellets according to the US Prescribing Information.
- •Previous participation in this study.
结局指标
主要结局
Cumulative incidence of clinically relevant bleeding events
时间窗: Up to week 52
次要结局
- Mortality related to thrombotic or thromboembolic events(Up to week 52)
- Occurrence of post-thrombotic syndrome (PTS)(Up to week 52)
- Incidence of serious adverse events (SAEs)(Up to week 52)
- Incidence of adverse events (AEs)(Up to week 52)
- Thrombotic burden at the end of the treatment period vs baseline, i.e. image-based resolution status of the thrombus (complete response, partial response, stable disease, progressive disease)(Baseline and up to week 12)
- Compliance with dabigatran etexilate treatment(Up to week 52)
- Occurence of all bleeding events(Up to week 52)
- Occurrence of recurrent Venous Thromboembolic Event (VTE)(Up to week 52)
- Recurrence of VTE while on treatment(Up to week 52)
- Duration of treatment with dabigatran etexilate(Up to week 52)
研究者
研究点 (20)
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