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

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Oct 2017

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

    • 10 Jun 2017 Biomarkers information updated
    • 09 Jan 2017 Status changed from active, no longer recruiting to completed.
    • 27 Dec 2016 According to Shire media release, based on interim results of this trial the U.S. FDA has approved the use of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] for use in surgical settings for both adult and pediatric patients.
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