The purpose of this study is to compare the
pharmacokinetics of BAY81-8973 and Advate after
-- Males, age 18 to 65 years - Subjects with Severe hemophilia A with a documented plasma FVIII level of <1% - ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records
-- Evidence of current or past inhibitor antibody - History of any congenital or acquired coagulation disorders other than hemophilia A - Platelet count <75,000/mm3 - Abnormal renal function (serum creatinine >2 times the upper limit of the normal [ULN] range) - Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULN or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
Sofia, Bulgaria, 1756
E-mail: [email protected]
Phone: Not Available
Single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A comparing pharmacokinetic parameters for BAY81-8973 and Advate