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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

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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: 07 Nov 2021

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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

  • 05 Feb 2020 According to a Takeda media release, pooled data from this and other five trials (NCT01599819, NCT01736475, NCT01945593, NCT02210091, NCT02585960) is being presented at the 13th Annual Congress of the European Association for Haemophilia and Allied Disorders, EAHAD 2020.
  • 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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