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Phase 3 Study To Evaluate Efficacy/Safety of Valoctocogene Roxaparvovec an AAV Vector-Mediated Gene Transfer of hFVIII at a Dose of 4E13vg/kg in Hemophilia A Patients With Residual FVIII Levels ≤1IU/dL Receiving Prophylactic FVIII Infusions

Trial Profile

Phase 3 Study To Evaluate Efficacy/Safety of Valoctocogene Roxaparvovec an AAV Vector-Mediated Gene Transfer of hFVIII at a Dose of 4E13vg/kg in Hemophilia A Patients With Residual FVIII Levels ≤1IU/dL Receiving Prophylactic FVIII Infusions

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

Latest Information Update: 05 Nov 2019

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At a glance

  • Drugs Valoctocogene-roxaparvovec (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Sponsors BioMarin Pharmaceutical
  • Most Recent Events

    • 01 Nov 2019 This trial has been Discontinued in Spain, according to European Clinical Trials Database.
    • 03 Sep 2019 Status changed from recruiting to active, no longer recruiting.
    • 28 May 2019 According to a BioMarin Pharmaceutical media release, this study expected to complete enrollment one to two quarters after GENEr8-1 in 2020.
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