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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

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 29 Apr 2024

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At a glance

  • Drugs Valoctocogene-roxaparvovec (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions
  • Acronyms GENEr8-AAV5+
  • Sponsors BioMarin Pharmaceutical

    • Most Recent Events

    • 22 Apr 2024 Planned End Date changed from 1 Jun 2024 to 1 Nov 2024.
    • 22 Apr 2024 Planned primary completion date changed from 1 Jun 2024 to 1 Nov 2024.
    • 25 Sep 2023 Planned End Date changed from 1 Nov 2027 to 1 Jun 2024.

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