Baxter Healthcare recently reported the results of a study of ADVATE® [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method], the company’s recombinant factor VIII product for the prevention and control of bleeding episodes and perioperative management of patients with hemophilia A. The lead investigator of the study was Victor Blanchette, MD, Chief of the Division of Hematology/Oncology, The Hospital for Sick Children, University of Toronto, Canada.
The study participants included 53 previously treated patients (52 boys and 1 girl) under six years old with moderately severe to severe hemophilia A. Blanchette and his colleagues measured pharmacokinetics, safety and efficacy in response to therapy. The subjects predominantly followed a prophylactic regimen of regular infusions of ADVATE®.
The results showed that more than 90% of bleeding episodes were managed with one to two infusions of ADVATE®. In addition, no FVIII inhibitors were detected and no complications or adverse effects occurred in the participants. Overall response was rated “excellent/good” in 93.8% of bleeding episodes
“For the first time, there are published data on the use of ADVATE® in managing hemophilia in young children,” said Blanchette. “Further, the study provides an understanding of the therapeutic issues in a subset of patients that are not traditionally included in clinical trials.”
The study, “Plasma and albumin-free recombinant factor VIII: pharmacokinetics, efficacy and safety in previously treated pediatric patients,” was published in the August 2008 issue of the Journal of Thrombosis and Haemostasis.
Source: Baxter press release dated October 20, 2008