LONG-TERM FOLLOW-UP WITH REGARD TO POTENTIAL IMMUNOGENICITY - CLINICAL-EXPERIENCE WITH NOVOSEVEN(R) (RECOMBINANT FACTOR VIIA)

Twenty-eight patients were followed up for potential specific antibody formation after repeated use of recombinant factor VIIa (rFVIIa). The population included 27 patients with congenital bleeding disorders an d I nonhemophiliac with an FVIII inhibitor. From 5 to 77 bleeding epis odes were treated during a follow-up period of at least 5 months. None of these repeatedly treated patients showed signs of antibody formati on against FVII or foreign protein that could be related to the treatm ent.