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

Completed

Conditions studied: Congenital Bleeding Disorder, Congenital FXIII Deficiency

In brief

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®.

Key facts

Study ID

NCT01862367

Run by

Novo Nordisk A/S

People needed

30

Starts

2013-05-17

Expected to finish

2019-06-26

Last updated by the study team

2019-07-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
• Able and willing to provide signed informed consent (or patient's legally acceptable representative (LAR) consent, if applicable), as required by local ethics committee, governmental or regulatory authorities
• Congenital FXIII A-subunit deficiency
• Actual or planned exposure to rFXIII

Where it is running

• Novo Nordisk Investigational Site — Orange, California, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Detroit, Michigan, United States
• Novo Nordisk Investigational Site — Minneapolis, Minnesota, United States
• Novo Nordisk Investigational Site — Cleveland, Ohio, United States
• Novo Nordisk Investigational Site — Columbus, Ohio, United States
• Novo Nordisk Investigational Site — St. John's, Newfoundland and Labrador, Canada
• Novo Nordisk Investigational Site — Toronto, Ontario, Canada
• Novo Nordisk Investigational Site — Debrecen, Hungary
• Novo Nordisk Investigational Site — Chieti, Italy
• Novo Nordisk Investigational Site — Genova, Italy
• Novo Nordisk Investigational Site — Barcelona, Spain
• Novo Nordisk Investigational Site — Madrid, Spain
• Novo Nordisk Investigational Site — Málaga, Spain
• Novo Nordisk Investigational Site — Tortosa, Spain
• Novo Nordisk Investigational Site — Aberdeen, United Kingdom

Full record on ClinicalTrials.gov

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