Purified Factor IX Using Monoclonal Immunoaffinity Technique: Clinical Trials

نویسندگان

  • Hugh C. Kim
  • Campbell W. McMillan
  • Gilbert C. White
  • Michael W. Horton
  • Parvin Saidi
چکیده

Replacement therapy for hemophilia B (factor IX deficiency) using prothrombin complex concentrate (PCC) has been associated with serious complications of thromboembolic events and transmission of viral infections. Monoclonal antibody-purified factor IX (Mononine) provides a highly purified factor IX concentrate, while eliminating other vitamin K-dependent factors (11, VII, and X). Mononine was evaluated for in vivo recovery, half-life, and for its safety and efficacy in 10 patients with hemophilia B. The in vivo recovery of factor IX with Mononine was a 0.67 ? 0.14 U/dL (mean -rSD) increase per 1 U/ kg of infused factor IX, and the biologic half-life (t,,J, determined using the terminal phase of elimination, was 22.6 f 8.1 hours. Comparison of in vivo recovery of other vitamin K-dependent factors following a single infusion of either Mononine or PCC showed that, whereas Mononine infusion caused no changes in other vitamin K-dependent factors or in

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Purified factor IX using monoclonal immunoaffinity technique: clinical trials in hemophilia B and comparison to prothrombin complex concentrates.

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تاریخ انتشار 2003