Assessment of the risk of inhibitor formation in previously treated patients with severe hemophilia A
Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study is to further monitor whether participants with severe Hemophilia A will develop inhibitors or antibodies at the later stage when switched from their current recombinant therapy produced from Chinese Hamster Ovary (CHO) cell line to Kogenate-FS raised in a Baby Hamster Kidney cell line.
- Subjects with severe hemophilia A (< 2% FVIII:C) - Subjects with no history of FVIII inhibitor antibody formation - Subjects with no measurable inhibitor activity - Subjects with at least 200 EDs with FVIII concentrate in total, including 20 EDs in the previous 6 months - Subjects whose current treatment with any CHO rFVIII product - Subjects with no elective surgery and/or continuous infusion FVIII administration is foreseen during the study - Subjects with normal prothrombin time (PT), partial thromboplastin time (PTT) compatible with FVIII deficiency
- Subjects with any other bleeding disease beside hemophilia A (i,e., von Willebrand's disease) - Subjects who have known intolerance or allergic reactions to constituents of rFVIII-FS or known hypersensitivity to mouse or hamster proteins - Any individual with a past history of severe reaction(s) to FVIII concentrates - Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry - Subjects who were receiving or had received other experimental drugs within 3 months prior to study entry - Subjects who require any medication for FVIII infusions
Assessment of the risk of inhibitor formation in subjects with severe hemophilia A when switched from a replacement therapy with a rFVIII produced by a Chinese Hamster Ovary (CHO) cell line to a rFVIII produced by a Baby Hamster Kidney (BHK) cell line (Kogenate® FS).
Single Group Assignment