NCT00713648

Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.

Conditions

• Congenital Bleeding Disorder
• Congenital FXIII Deficiency

Interventions

Type	Name	Description
DRUG	catridecacog	35 IU/kg body weight, i.v. administration, once every 4 weeks

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-07-11
• Last updated: 2017-02-24
• Results posted: 2014-07-14

Locations

35 sites across 11 countries: United States, Austria, Canada, Finland, France, Germany, Israel, Italy, Spain, Switzerland, United Kingdom