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As many as 30% of patients with classical hemophilia (factor VIII deficiency) develop neutralizing antibodies (inhibitors) that render treatment with factor VIII concentrates futile. Elucidating the factors underlying inhibitor formation might result in measures to reduce the frequency of this complication.
To identify a potential association between the type of factor VIII replacement product and the development of inhibitors, a multinational team of investigators initiated a randomized, open-label trial (SIPPET), partially funded by the manufacturers of plasma-derived concentrates. The trial included 251children with severe hemophilia (factor VIII coagulant activity <1 IU/dL) not previously treated with commercial clotting-factor concentra…