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A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII at a Dose of 4E13vg/kg in Hemophilia A Patients With Residual FVIII Levels ≤1IU/dL Receiving Prophylactic FVIII Infusions

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A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII at a Dose of 4E13vg/kg in Hemophilia A Patients With Residual FVIII Levels ≤1IU/dL Receiving Prophylactic FVIII Infusions

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2023

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At a glance

  • Drugs Valoctocogene-roxaparvovec (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms GENEr8-2
  • Sponsors BioMarin Pharmaceutical

    • Most Recent Events

    • 26 Sep 2023 Status changed from active, no longer recruiting to completed.
    • 14 Sep 2021 Planned End Date changed from 1 Jul 2023 to 1 May 2023.
    • 15 Jan 2021 Planned End Date changed from 1 Mar 2024 to 1 Jul 2023.

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