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Open label, single arm safety prospective cohort study of dabigatran etexilate for secondary prevention of venous thromboembolism in children from 0 to less than 18 years

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Trial Profile

Open label, single arm safety prospective cohort study of dabigatran etexilate for secondary prevention of venous thromboembolism in children from 0 to less than 18 years

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Apr 2022

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At a glance

  • Drugs Dabigatran etexilate (Primary)
  • Indications Venous thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Boehringer Ingelheim; Boehringer Ingelheim Pharma KG

Most Recent Events

  • 15 Nov 2021 Results presented at the American Heart Association Scientific Sessions 2021
  • 26 Feb 2021 Results of population Pharmacokinetic Modeling and Simulation Support from five trials ((NCT02223260, NCT01083732, NCT00844415, NCT01895777, NCT02197416) published in the Journal of Thrombosis and Haemostasis
  • 08 Dec 2020 Results of sub-group analysis of two phase IIb/III DE trials assessing efficacy and safety of dabigatran etexilate for the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia, presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology.

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