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A Multicenter, Open-Label Study to Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) in subjects with Severe Hem...

Update Il y a 5 ans
Reference: EUCTR2005-005246-40

A Multicenter, Open-Label Study to Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) in subjects with Severe Hemophilia B

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Extract

To evaluate the efficacy and safety of BeneFIX infused as prophylaxis regimens, compared with BeneFIX administered in an on-demand regimen only.

Inclusion criteria

  • Male subjects, aged 6 years to 65 years, with a documented history of moderately severe or severe Hemophilia B (FIX:C≤2%) and with a minimum of 12 bleeding episodes, of which 6 must be joint bleeds, in the 12 months before screening

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