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Extrait
Demonstration of the safety and efficacy of ReFacto AF administered by bolus injection or continuous infusion during the perioperative management of patients with hemophilia A undergoing major surgery
Critère d'inclusion
- Male subjects with hemophilia A (FVIII:C ≤2% confirmed at screening), previously treated with ≥ 150 exposure days to any Factor VIII product, undergoing elective major surgery that is anticipated to require FVIII infusions over a period of at least 6 days following surgery