A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency

Trial Profile

A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Feb 2017

At a glance

  • Drugs Catridecacog (Primary)
  • Indications Factor XIII deficiency
  • Focus Registrational; Therapeutic Use
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 27 Dec 2013 New trial record
    • 23 Dec 2013 The US FDA approved Tretten for the treatment of congenital factor XIII A-subunit deficiency based on results from a clinical programme, including this trial.
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