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A Phase 3, Single-arm, Multicenter, Multinational, Open-label, One-way Crossover Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged ≥ 12 Years With Severe Hemophilia A or B With or Without Inhibitory Antibodies to Factor VIII or IX

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A Phase 3, Single-arm, Multicenter, Multinational, Open-label, One-way Crossover Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged ≥ 12 Years With Severe Hemophilia A or B With or Without Inhibitory Antibodies to Factor VIII or IX

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Oct 2024

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At a glance

  • Drugs Fitusiran (Primary) ; Factor VIII; Factor VIII inhibitors
  • Indications Haemophilia A; Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms ATLAS-NEO
  • Sponsors Sanofi

    • Most Recent Events

    • 21 Oct 2024 Planned End Date changed from 1 Mar 2028 to 1 Jun 2028.
    • 21 Oct 2024 Planned primary completion date changed from 15 Apr 2026 to 12 Sep 2026.
    • 21 Oct 2024 Status changed from recruiting to active, no longer recruiting.

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