Study Evaluating ReFacto AF in Severe Hemophilia A

An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A

To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.

Inclusion Criteria:

• Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
• Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
• Age greater than or equal to 12 years
• History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
• Adequate laboratory results

Exclusion Criteria:

• Presence of any bleeding disorder in addition to hemophilia A
• Concomitant therapy with immunosuppressive drugs
• Current or historical Factor VIII inhibitor
• Treatment with any investigational drug or device within the past 30 days