Single Dose, Open Label, Uncontrolled, Safety Trial of Intravenous Administration of Idarucizumab to Paediatric Patients Enrolled From Ongoing Phase IIb/III Clinical Trials With Dabigatran Etexilate for the Treatment and Secondary Prevention of Venous Thromboembolism.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Participants With Drug-related Adverse Events (AEs)
研究概览
简要总结
The trial objective is to demonstrate the safety of idarucizumab, as assessed by the occurence of patients with drug related adverse events (including immune reactions) and all-cause mortality in paediatric venous thromboembolism patients treated with dabigatran in ongoing clinical trials who require emergency surgery/urgent procedures or patients who have life-threatening or uncontrolled bleeding which requires urgent intervention, when rapid reversal of the anticoagulant effect of dabigatran is needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 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
Idarucizumab
干预措施: Idarucizumab (Drug)
结局指标
主要结局
Number of Participants With Drug-related Adverse Events (AEs)
时间窗: From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days
Number of participants with drug-related adverse events (AEs) including immune reactions and all cause mortality during the trial.
次要结局
- Percent Change of Coagulation Time for Diluted Thrombin Time (dTT) and Ecarin Clotting Time (ECT) at 30 Minutes Post-dose Compared With Pre-dose(At immediately prior to administration of vial 1 of Idarucizumab and 30 minutes (min) post vial 2 administration.)
- Number of Participants Per Bleeding Status During the Trial(From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days)
- Duration of Reversal of the Dabigatran Effect Sustained up to 24 Hours Post-dose (Based on the Coagulation Time for dTT and ECT)(From end of vial 2 of Idarucizumab up to 24h.)
- Number of Participants With Clinical Conditions Contributing to Bleeding During the Trial(From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days)
- Number of Participants With Cessation of Bleeding(From vial 1 of Idarucizumab through vial 2 of Idarucizumab, up to 24h 30min.)
- Time to Achieve Reversal of the Dabigatran Effect (Based on the Coagulation Time for dTT and ECT)(From end of vial 2 of Idarucizumab up to 24h.)
- Number of Participants Developing Treatment-emergent Antidrug Antibodies (ADA) With Cross Reactivity to Idarucizumab(At day 25 post vial 2 of Idarucizumab administration, up to 1 day)