SAFETY, EFFICACY AND BIOLOGIC HALF LIFE OF NEW SOLVENT/DETERGENT TREATED IGIV

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This was a phase I, blinded cross-over evaluation of two new intravenous gammaglobulin preparations that have been treated with solvent and detergent to reduce the risk of transmitting viral infections. The study consisted of a single infusion of either the standard 5% Gamimune or the 5% solvent/detergent preparation followed by an infusion of the alternate preparation. These infusions were followed by a blinded crossover using 10% Gamimune-N and 10% solvent/detergent treated gammaglobulin. All patients returned for a fifth infusion of their usual licensed preparation so that blood counts and chemistries could be obtained at exit. All patients were treated with the same dose and schedule that they followed prior to the study. The safety of the preparations was assessed by recording clinical reactions during or within 24 hours of the infusions and by measuring a panel of blood chemistries and blood counts. In addition, the half-life of the gammaglobulin was determined by measuring levels at several time points between infusions. A total of 7 patients were enrolled in this study at this site, for a total of 35 visits. All were males over 12 years of age with either X-linked or Common Variable Agammaglobulinemia. Six were Caucasian and one American Indian. There were no clinical or laboratory abnormalities during this study which is now closed.