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

Update Il y a 4 ans
Reference: EUCTR2008-007997-39

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Extract

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

Inclusion criteria

  • 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

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