Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A

Exclusion Criteria

• •The subject has a known hypersensitivity to mouse or hamster proteins or to factor VIII concentrates.
• •The subject has a history of factor VIII inhibitors with titer \>=0.8 BU (Bethesda Assay) or \>=0.4 BU (Nijmegen modification of the Bethesda Assay) any time prior to screening.
• •The subject has a detectable factor VIII inhibitor at screening, \>=0.4 BU (Nijmegen modification of the Bethesda Assay), in the Baxter central laboratory.
• •The subject has severe chronic 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.
• •The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (e.g. qualitative platelet defect or von Willebrand´s Disease).
• •The subject has participated in another investigational study within 30 days of enrollment.
• •The subject´s clinical condition may require a major or moderate surgery (estimated blood loss \>500 mL) during the period of participation in the study.