Phase 3, Prospective, Multi-center, Open Label Study to Investigate Safety, Immunogenicity, and Hemostatic Efficacy of PEGylated Factor VIII (BAX 855) in Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) < 6 Years With Severe Hemophilia A (FVIII < 1%)

Trial Profile

Phase 3, Prospective, Multi-center, Open Label Study to Investigate Safety, Immunogenicity, and Hemostatic Efficacy of PEGylated Factor VIII (BAX 855) in Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) < 6 Years With Severe Hemophilia A (FVIII < 1%)

Recruiting
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; Shire
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 06 Dec 2016 Results assessing Immunogenicity of Rurioctocog-alfa-pegol using patient data (n=243) from this and other six trials (NCT02585960, NCT02210091, NCT01736475, NCT01913405, NCT01945593, NCT01599819) presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 02 Dec 2015 New trial record
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