The present clinical study was designed to evaluate the efficacy, pharmacokinetics and safety of a new 10% liquid intravenous immune globulin in patients with primary immunodeficiency diseases. Sixty-one adults and children with primary immuno-deficiency diseases received doses of 300–600 mg/kg body weight every 21–28 days for 12 months. No validated acute serious bacterial infections were reported. The 95% confidence interval for the annualized rate of acute serious bacterial infections (primary endpoint) was 0–0.060. A total of four predefined validated other bacterial infections commonly occurring in primary immunodeficiency disease subjects were observed; none were serious, severe or resulted in hospitalization. The median elimination half-life of IgG was 35 days. Median total IgG trough levels varied from 9.6 to 11.2 g/L. Temporally associated adverse experiences were determined for 72 h after each infusion and the most common adverse experience was headache, which was associated with 6.9% of infusions. The study met the primary endpoint for efficacy and demonstrated excellent tolerability of the new 10% liquid intravenous imunoglobulin preparation.
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ACKNOWLEDGMENTS
The authors thank the following persons from Baxter (Vienna, Austria, and Westlake Village, CA, USA) for their support in the successful completion of this study, through study management, data management, biostatistics or reviewing the manuscript: Werner Engl, Lisa Grubbs, Cora Hiebinger, Bill Knowlton, Friedrich Maritsch, Queennette Santiago, Richard Schiff, Phillip Schroth, Marlies Sharkhawy and Cindy Wu.
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Church, J.A., Leibl, H., Stein, M.R. et al. Efficacy, Safety and Tolerability of a New 10% Liquid Intravenous Immune Globulin [IGIV 10%] in Patients with Primary Immunodeficiency. J Clin Immunol 26, 388–395 (2006). https://doi.org/10.1007/s10875-006-9025-3
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DOI: https://doi.org/10.1007/s10875-006-9025-3