Mobile

A Randomised, Two-way, Blinded, Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) with a Full-Length Recombinant Factor VIII Pr...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-000720-16

A Randomised, Two-way, Blinded, Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) with a Full-Length Recombinant Factor VIII Preparation (FLrFVIII, Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients with Hemophilia A

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

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%

Liens