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A Phase 1/2 Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients With Residual FVIII Levels ≤ 1 IU/dL and Pre-existing Antibodies Against AAV5

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Trial Profile

A Phase 1/2 Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients With Residual FVIII Levels ≤ 1 IU/dL and Pre-existing Antibodies Against AAV5

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 24 Jan 2019

At a glance

  • Drugs Valoctocogene-roxaparvovec (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions
  • Sponsors BioMarin Pharmaceutical

    • Most Recent Events

    • 15 May 2018 According to a BioMarin Pharmaceuticals media release, first patient has been dosed in this study.
    • 27 Apr 2018 Status changed from planning to recruiting.
    • 25 Apr 2018 According to a BioMarin Pharmaceuticals media release, company expects to start in second quarter of 2018.
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