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

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

Completed
Phase of Trial: Phase II/III

Latest Information Update: 27 Nov 2017

At a glance

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

    • 06 Dec 2016 Results of ad-hoc analysis assessing target joint status was presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 06 Dec 2016 Results assessing Immunogenicity of Rurioctocog-alfa-pegol using patient data (n=243) from this and other six trials (NCT02585960, NCT02210091, NCT01913405, NCT01945593, NCT01599819, NCT02615691) presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 04 Apr 2016 According to a Baxalta media release, the Ministry of Health, Labor and Welfare in Japan approved Adynovate [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant factor VIII (rFVIII) treatment for patients 12 years and older with haemophilia A. The approval was based on the results of this trial.
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