Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980

Exclusion Criteria

• •Individuals with abnormal renal function (serum creatinine concentrations greater than 1.3 mg/dL) or active hepatic disease (persistent aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] increases to greater than five times the upper limit of normal).
• •Individuals with anemia, as defined by hemoglobin level less than 12 g/dL
• •Any individual with a past history of severe reaction(s) to FVIII products
• •Any individual on interferon treatment or who has received interferon within the previous 3 months
• •Any individual with thrombocytopenia (platelets greater than or equal to 100,000 cells/mm3) or known hematologic/bleeding problems other than hemophilia A
• •Any individual who is receiving or has received other experimental drugs within 3 months prior to study entry
• •Any individual with known dislipidemic disease or actively taking cholesterol lowering drugs for the treatment of hypercholesterolemia or hyperlipidemia (e.g., statins, cholesterol absorption inhibitors, bile acid sequestrants, nicotinic acid or fibrates) or individuals taking anaesthetic drugs
• •Any individual who requires pre-medication for FVIII infusions (e.g., antihistamines)
• •Any individual with high blood pressure (defined as diastolic blood pressure great than or equal to 100 mm/Hg)
• •Any patient who cannot forego FVIII treatment for at least 4 days prior to study entry or between study infusions due to a need for more frequent prophylactic treatment because of a pre-existing medical condition
• •Any patient with known allergy or severe reactions to liposomes or PEG
• •Individuals with any other known disease affecting hemostasis besides hemophilia A
• •Any patient who is not suitable for participation in this trial for any reason, according to the Investigator