NCT01862367

Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect. The study will aim at observing all patients exposed to NovoThirteen® in the EU, and additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.

Conditions

• Congenital Bleeding Disorder
• Congenital FXIII Deficiency

Interventions

Type	Name	Description
DRUG	catridecacog	No treatment given. All patients enrolled in this observational study will receive their medication through usual commercial channels.

Timeline

• Start date: 2013-05-17
• Primary completion: 2019-06-26
• Completion: 2019-06-26
• First posted: 2013-05-24
• Last updated: 2019-07-09

Locations

17 sites across 6 countries: United States, Canada, Hungary, Italy, Spain, United Kingdom