Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

A Single Dose, Randomized, Double-Blind, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) Manufactured by the Current Process (ReFacto) and by an Albumin Free Manufacturing Process (ReFacto AF)

The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.

Inclusion Criteria:

• Severe hemophilia A (FVIII:C < 1% at local laboratory)
• Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product
• Age greater than or equal to 12 years\

Exclusion Criteria:

• The presence of any bleeding disorder in addition to hemophilia A
• Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (IVIG), routine systemic corticosteroid use)
• History of detectable factor VIII inhibitor