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
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
- 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