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Clotting factors used for the treatment of hemophilia can be modified to prolong their plasma half-life, thereby decreasing the need for frequent intravenous infusions. However, each modified clotting factor must be evaluated in clinical trials to assess its efficacy and safety.
Investigators have now conducted an industry-funded, phase II/III, multicenter, open-label study to assess the on-demand and prophylactic use of a pegylated factor VIII (PEG-VIII) concentrate in 137 patients with severe hemophilia A. Of these patients, 17 received PEG-VIII for hemorrhages (median treatment dose, 31 U/kg per episode, followed by maintenance doses of 29 U/kg given within 48 hours), and 120 received PEG-VIII prophylaxis (45 U/kg twice weekly). Results w…