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A Two-Part, Open-Label, Randomized, Placebo-Controlled Crossover Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Subjects

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Trial Profile

A Two-Part, Open-Label, Randomized, Placebo-Controlled Crossover Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Feb 2025

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At a glance

  • Drugs Eptacog alfa (Primary) ; Milvexian (Primary) ; Prothrombin complex concentrate (Primary)
  • Indications Acute coronary syndromes; Stroke; Thrombosis; Venous thromboembolism
  • Focus Pharmacodynamics
  • Sponsors Janssen Research & Development

Most Recent Events

  • 10 Dec 2024 Results assessing potential of 4-Factor Prothrombin Complex Concentrate (4F-PCC) and recombinant human factor VIIa (rFVIIa) to reverse the anticoagulant effects of milvexian in healthy participants presented at the 66th American Society of Hematology Annual Meeting and Exposition.
  • 05 Jul 2023 Status changed from recruiting to completed.
  • 02 May 2023 Planned End Date changed from 29 Aug 2023 to 6 Jun 2023.

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