NCT00978380

Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.

Conditions

• Congenital Bleeding Disorder
• Congenital FXIII Deficiency

Interventions

Type	Name	Description
DRUG	catridecacog	Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)

Timeline

• Start date: 2009-09-21
• Primary completion: 2015-10-20
• Completion: 2015-10-20
• First posted: 2009-09-16
• Last updated: 2018-01-24
• Results posted: 2016-12-13

Locations

34 sites across 12 countries: United States, Austria, Canada, Finland, France, Germany, Israel, Italy, Japan, Spain, Switzerland, United Kingdom