This is a single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY 14-2222).
- Males, age 18 to 65 years - Subjects with Severe hemophilia A with a documented plasma FVIII level of <1% - >/= 150 ED (exposure days) with FVIII concentrates(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 range) - Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x the upper limit of normal 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
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
Sofia, Bulgaria, 1756
E-mail: [email protected]
Phone: Not Available
Single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY14-2222)