Mobile

An Open-Label Study to Evaluate Prophylaxis Treatment, and to Characterize the , Efficacy, Safety and Pharmacokinetics of B Domain Deleted Recombinant Factor VIII Albumin Free (ReFacto AF) in Children...

Update Il y a 4 ans
Reference: EUCTR2006-005575-17

An Open-Label Study to Evaluate Prophylaxis Treatment, and to Characterize the , Efficacy, Safety and Pharmacokinetics of B Domain Deleted Recombinant Factor VIII Albumin Free (ReFacto AF) in Children With Hemophilia A Estudio abierto para evaluar el tratamiento profiláctico y para caracterizar la eficacia, la seguridad y la farmacocinética del factor VIII recombinante con delección del dominio B sin albúmina (ReFacto® AF) en niños con hemofilia A

  • | Country :
    • -
  • | organs :
    • -
  • | Specialty :
    • -

Extract

To demonstrate that ReFacto AF prophylaxis reduces annualized bleeding rates (ABRs) relative to on-demand therapy.

Inclusion criteria

  • Younger Male Haemophilia A patients < 6 years of age with moderately severe to severe hemophilia A (FVIII activity =< 2%), with previous FVIII replacement therapy experience (>=50 exposure days),Niños menores de 6 años con hemofilia A de grado moderadamente grave a grave (actividad de FVIII =< 2%), con experiencia previa en tratamiento sustitutivo de FVIII (días de exposición >=50)

Links