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A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A

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Trial Profile

A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 13 Dec 2022

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At a glance

  • Drugs Rurioctocog alfa pegol (Primary) ; Octocog alfa
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms PROLONG-ATE
  • Sponsors Baxalta; Baxter Healthcare Corporation

    • Most Recent Events

    • 03 Feb 2021 According to a Takeda media release, data from this study are being presented at the Virtual European Association for Haemophilia and Allied Disorders Congress (EAHAD 2021).
    • 05 Feb 2020 According to a Takeda media release, pooled data from this and other five trials (NCT01599819, NCT01913405, NCT01945593, NCT02210091, NCT02585960) is being presented at the 13th Annual Congress of the European Association for Haemophilia and Allied Disorders, EAHAD 2020.
    • 18 Jul 2019 This trial has been completed in Romania, according to European Clinical Trials Database

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