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A Phase 3 Prospective, Uncontrolled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity of BAX 855 (PEGylated Full-length Recombinant FVIII) in Previously Treated Pediatric Patients With Severe Hemophilia A

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Trial Profile

A Phase 3 Prospective, Uncontrolled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity of BAX 855 (PEGylated Full-length Recombinant FVIII) in Previously Treated Pediatric Patients With Severe Hemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Feb 2023

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At a glance

  • Drugs Rurioctocog alfa pegol (Primary) ; Octocog alfa
  • Indications Haemophilia A
  • Focus Adverse reactions; Registrational
  • Acronyms BAX 855 Pediatric
  • Sponsors Baxalta; Baxter Healthcare Corporation; Baxter Innovations GmbH

    • Most Recent Events

    • 05 Feb 2020 According to a Takeda media release, pooled data from this and other five trials (NCT01599819, NCT01736475, NCT01913405, NCT01945593, NCT02585960) is being presented at the 13th Annual Congress of the European Association for Haemophilia and Allied Disorders, EAHAD 2020.
    • 26 Nov 2018 According to a Shire media release, based on data from this trial Health Canada approved rurioctocog alfa pegol (ADYNOVATE) for the prophylaxis as well as on-demand control of bleeding episodes and for use during surgery in haemophilia A patients younger than 12 years of age.
    • 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.

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