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A pivotal randomized, double-blind, multicenter, placebo-controlled Phase 3 trial of the oral solution containing tranexamic acid to prevent possible oral haemorrhaging in patients treated with anticoagulants (blood thinners) and undergoing extraction of one or more teeth

Trial Profile

A pivotal randomized, double-blind, multicenter, placebo-controlled Phase 3 trial of the oral solution containing tranexamic acid to prevent possible oral haemorrhaging in patients treated with anticoagulants (blood thinners) and undergoing extraction of one or more teeth

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Feb 2024

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At a glance

  • Drugs Tranexamic acid (Primary)
  • Indications Haemorrhage
  • Focus Registrational; Therapeutic Use
  • Sponsors Hyloris Pharmaceuticals

Most Recent Events

  • 14 Feb 2024 According to a Hyloris Pharmaceuticals media release, data from the Phase 1 allowed Hyloris to define the optimal administration regimen for its proprietary oral solution for this current Phase 3 trial.
  • 14 Feb 2024 According to a Hyloris Pharmaceuticals media release, recruitment is expected to be completed around the end of 2024 with final results available in the first half of 2025. An estimated 280 patients will be recruited at approximately 20 clinical sites across Europe and the United States.
  • 14 Feb 2024 Status changed from planning to recruiting, according to a Hyloris Pharmaceuticals media release.

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