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Extrait
Safety: To determine the incidence rate of Factor VIII inhibitors in the study patient population Efficacy: To establish the bioequivalence of ReFacto AF with a full-length recombinant Factor VIII (Advate) using the one stage factor VIII activity assay.
Critère d'inclusion
- For all patients participating in the trial:Male subjects with severe or moderately severe hemophilia A (FVIII:C = 2%) previously treated with = 150 exposure days to any Factor VIII product.For patients participating in the Pharmacokinetic period of the trial:Male subjects as described immediately above except they must have a Factor VIII:C of = 1%