Open-label, Randomized, Parallel-group, Active-controlled, Multi-centre Non-inferiority Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment in Children From Birth to Less Than 18 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 65
- 主要终点
- Composite Primary Endpoint
研究概览
简要总结
The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 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
Dabigatran etexilate capsules, pellets or liquid formulation given BID in an open label fashion for 3 months
干预措施: dabigatran etexilate (Drug)
standard of care
Low molecular weight heparin, vitamin K antagonist or fondaparinux prescribed in an open label fashion for 3 months (these medications will not supplied in this study as IMP)
干预措施: standard of care (Drug)
结局指标
主要结局
Composite Primary Endpoint
时间窗: From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.
The primary endpoint was the combined endpoint of the proportions of patients with: * Complete thrombus resolution * Freedom from recurrent VTE * Freedom from mortality related to VTE. The events outlined in the above combined primary endpoint were assessed by radiologists or other such qualified clinicians using an appropriate method such as ultrasound, echocardiography, venography, or CT scan, based on the location of the thrombus and the test used to perform the baseline assessment. The primary efficacy endpoint contained 3 components. Each component was evaluated separately, and only if the criteria for all 3 components were satisfied, the primary endpoint was considered achieved.
次要结局
- Steady State Plasma Concentrations of Total Dabigatran at Visit 3(From the time of randomisation until visit 3)
- Steady State Plasma Concentrations After at Least 3 Days Following Any Dabigatran Etexilate Dose Adjustment(From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.)
- Frequency of Dose Adjustment During the Treatment Phase(From first administration of trial medication until last administration of trial medication +6 days (residual effect period).)
- Frequency of Patients Switching the Type of Anti-coagulation Therapy Including Dabigatran Etexilate to Standard of Care Treatment and Switching From One Standard of Care Treatment to Another(From first administration of trial medication until last administration of trial medication +6 days (residual effect period).)
- Freedom From Thrombus Progression at End of Therapy Compared With Baseline(From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.)
- Freedom From Major Bleeding Events (MBEs)(From first administration of trial medication until last administration of trial medication +6 days (residual effect period). Up to 97 days.)
- All Bleeding Events(From first administration of trial medication until last adminstration of trial medication +6 days (residual effect period). Up to 97 days.)
- All-cause Mortality(From first administration of trial medication until last administration of trial medication +6 days (residual effect period). Up to 97 days.)
- All Components of the Primary Efficacy Endpoint(From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.)
- Assessment of the Acceptability of an Age-appropriate Formulation at End of Therapy (Capsules)(Assessment at the last study visit at day 84 (+- 7 days), or at day of early termination.)
- Assessment of the Acceptability of an Age-appropriate Formulation at End of Therapy (Pellets)(Assessment at the last study visit at day 84 (+- 7 days), or at day of early termination.)
- Assessment of the Acceptability of an Age-appropriate Formulation at End of Therapy (Oral Liquid Formulation - OLF)(Assessment at the last study visit at day 84 (+- 7 days), or at day of early termination.)