A Phase III, Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 13
- 主要终点
- Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time
研究概览
简要总结
The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure.
The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older 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
Group A - patients with uncontrolled or life-threatening bleeding
干预措施: Idarucizumab (Drug)
Group B - patients not bleeding but requiring emergency surgery or invasive procedure
干预措施: Idarucizumab (Drug)
结局指标
主要结局
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time
时间窗: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of ecarin clotting time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is \> 100, it was set to 100. 100% ULN is 41.26 seconds.
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time
时间窗: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is \> 100, it was set to 100. 100% ULN is 35.54 seconds.
次要结局
- Numbers of Participants With Any Adverse Events - Including Post Treatment Period(Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.)
- Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only)(Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period.)
- Number of Participants With Major Bleeding (for Group B Only) Intra-operatively and up to 24 Hours Post-surgery(Up to 24 hours post-surgery.)
- Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)(From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.)
- Numbers of Participants With Any Adverse Events - on Treatment(Since the first infusion up until 5 days after the completion of the second infusion.)
- Number of Participants With Thrombotic Events - on Treatment(Since the first infusion up until 5 days after the completion of the second infusion.)
- Minimum Unbound Sum Dabigatran Concentrations Since the End of First Infusion up to 4 Hours After the Completion of the Last Infusion (Cmin,1)(Just prior to the second infusion (last infusion) and 10 minutes (min), 30 min, 1 hour (h), 2 h, and 4 h after the end of the second infusion.)
- Maximum Reversal of Anticoagulation as Measured by Thrombin Time (TT)(From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.)
- Number of Participants With Serious Adverse Events - on Treatment(Since the first infusion up until 5 days after the completion of the second infusion.)
- Number of Participants With Drug-related Adverse Events - on Treatment(Since the first infusion up until 5 days after the completion of the second infusion.)
- Number of Participants With Drug-related Adverse Events - Including Post Treatment Period(Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.)
- Number of Participants With Immune Reaction Adverse Event - on Treatment(Since the first infusion up until 5 days after the completion of the second infusion.)
- Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period(Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.)
- Number of Participants With Thrombotic Events - Including Post Treatment Period(Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.)
- Number of Participants With Serious Adverse Events - Including Post Treatment Period(Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.)