A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial

Trial Profile

A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Aug 2017

At a glance

  • Drugs Idarucizumab (Primary)
  • Indications Blood coagulation disorders; Haemorrhage
  • Focus Registrational; Therapeutic Use
  • Acronyms RE-VERSE AD
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 03 Aug 2017 Results published in the New England Journal of Medicine
    • 11 Jul 2017 Primary endpoint has been met. (Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of dTT or ECT, at any time point from the end of the first infusion up to 4 hours after the last infusion.), according to a Boehringer Ingelheim Pharmaceuticals media release.
    • 11 Jul 2017 Final results published in a Boehringer Ingelheim Pharmaceuticals media release.
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