Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.