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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Aug 2021

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At a glance

  • Drugs Idarucizumab (Primary) ; Dabigatran etexilate
  • Indications Blood coagulation disorders; Haemorrhage
  • Focus Therapeutic Use
  • Sponsors Boehringer Ingelheim

Most Recent Events

  • 28 Aug 2020 Status changed from recruiting to completed.
  • 27 Apr 2020 Status changed from suspended to recruiting.
  • 03 Apr 2020 Status changed from recruiting to suspended. Reason the study was stopped: Due to the current COVID-19 pandemic, the recruitment of new subjects is temporarily discontinued. Ongoing, randomised patients are managed per Trial Protocol.

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