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A two part randomized, cross-over, open-label trial to evaluate the pharmacokinetics, efficacy, and safety profile of plasma-protein free recombinant FVIII formulated with sucrose (BAY 81-8973) in pre...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-012149-43

A two part randomized, cross-over, open-label trial to evaluate the pharmacokinetics, efficacy, and safety profile of plasma-protein free recombinant FVIII formulated with sucrose (BAY 81-8973) in previously treated subjects with severe hemophilia A under prophylaxis therapy

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Extrait

To demonstrate efficacy and safety of BAY 81-8973 for treatment of bleeds and prophylaxis (as of Amd 8)

Critère d'inclusion

  • Severe hemophilia A (< 1% FVIII:C)

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