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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jan 2018

At a glance

  • Drugs Rurioctocog alfa pegol (Primary) ; Rurioctocog alfa
  • Indications Haemophilia A
  • Focus Adverse reactions; Registrational
  • Sponsors Baxalta; Baxter Healthcare Corporation; Baxter Innovations GmbH
  • Most Recent Events

    • 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.
    • 10 Jun 2017 Biomarkers information updated
    • 01 Mar 2017 Results published in the Haemophilia
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