NCT01253811

Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Not accepted

Summary

This trial will be conducted in Asia, Europe and the United States of America (USA). The aim of this clinical trial is to investigate long-term safety of rFXIII when administered for prevention of bleeding episodes in children aged between 1 and 6 years with congenital FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760 (mentor™4, NCT01230021). If applicable the trial will be extended up to maximum 3 years dependent on when recombinant factor XIII will be commercially available in subject's respective country for use in children of 1-6 years of age.

Conditions

• Congenital Bleeding Disorder
• Congenital FXIII Deficiency

Interventions

Type	Name	Description
DRUG	catridecacog	Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg body weight every 4th week

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2010-12-03
• Last updated: 2016-06-24
• Results posted: 2016-06-24

Locations

4 sites across 3 countries: United States, Israel, United Kingdom