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Open-label Safety Study in Adults and Adolescents With Haemophilia A With and Without FVIII Inhibitors Switching Directly From Emicizumab Prophylaxis to NNC0365-3769 (Mim8) Prophylaxis

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Trial Profile

Open-label Safety Study in Adults and Adolescents With Haemophilia A With and Without FVIII Inhibitors Switching Directly From Emicizumab Prophylaxis to NNC0365-3769 (Mim8) Prophylaxis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2025

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At a glance

  • Drugs Mim 8 (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; Registrational
  • Acronyms FRONTIER 5
  • Sponsors Novo Nordisk

    • Most Recent Events

    • 07 Feb 2025 According to a Novo Nordisk media release, Novo Nordisk expects Mim8 regulatory submission during 2025. Data from the ongoing phase 3 FRONTIER programme will be disclosed at upcoming congresses and in publications in 2025 and 2026.
    • 18 Nov 2024 Status changed from active, no longer recruiting to completed.
    • 31 Jan 2024 Planned End Date changed from 10 Jan 2025 to 11 Dec 2024.

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