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A Phase 3, Multi-Center, Open Label Study of Efficacy and Safety of PEGylated rFVIII (BAX 855) in Previously Treated Patients With Severe Hemophilia A Undergoing Surgical or Other Invasive Procedures

Trial Profile

A Phase 3, Multi-Center, Open Label Study of Efficacy and Safety of PEGylated rFVIII (BAX 855) in Previously Treated Patients With Severe Hemophilia A Undergoing Surgical or Other Invasive Procedures

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 May 2019

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At a glance

  • Drugs Rurioctocog alfa pegol (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Sponsors Baxalta; Baxter Healthcare Corporation; Baxter International; Shire
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 15 Jan 2018 According to a Shire media release, based on data from this and two other phase III trials, the European Commission (EC) has granted Marketing Authorization for ADYNOVI, an extended half-life recombinant factor VIII (rFVIII) treatment for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.
    • 09 Jan 2017 Status changed from active, no longer recruiting to completed.
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