A Postauthorization Safety Surveillance Study of Patients Switching to ReFacto AF From ReFacto or Other Factor VIII Products in Usual Care Settings

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-007997-39

  • | Pays :
  • -
  • | Organes :
  • -
  • | Spécialités :
  • -

Extrait

To evaluate clinically significant FVIII inhibitor development in a large number of severe hemophila A patients treated with ReFacto AF in usual use settings.


Critère d'inclusion

  • Severe haemophilia A (FVIII:C <1%) in male patients ≥12 years of age with a treatment history of >150 EDs to prior recombinant or plasma-derived FVIII replacement products and transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products