BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

This is an interventional treatment trial for Hemophilia A focused on measuring Hemophilia A, FVIII disease, rFVIII Read More

Inclusion Criteria:

• Males aged 12 to 70 years
• Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C)
• Subjects with equal or greater than 150 exposure days (EDs) with any FVIII in total
• Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule
• Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records
• Subjects with no measurable inhibitor activity
• Subjects with no history of FVIII inhibitor antibody formation
• Written informed consent by subject and parent / legal representative, if < 18 years

Exclusion Criteria:

• Subjects who are receiving primary prophylaxis
• Subjects on prophylaxis with documented requirements of > 75 IU/kg/week
• Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
• Subjects with abnormal renal function
• Subjects with elevated hepatic transaminases
• Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
• Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)
• Subjects who require any pre-medication for FVIII injections