A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency. Safety Extension Trial to F13CD-3760

Trial Profile

A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency. Safety Extension Trial to F13CD-3760

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jun 2016

At a glance

  • Drugs Catridecacog (Primary)
  • Indications Factor XIII deficiency
  • Focus Adverse reactions
  • Acronyms Mentor-5
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 23 Jun 2016 Time frame of primary end point changed from every "4th week, from 0 to week 56" to "Week 0 to end of trial visit (week 173) for a minimum period of 52 weeks".
    • 07 Apr 2015 Status changed from active, no longer recruiting to completed, as reported by ClinicalTrials.gov.
    • 03 Jul 2014 New trial record
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