Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study
Status:
Completed
Trial end date:
2019-06-26
Target enrollment:
Participant gender:
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®.