Author: Wasserman, Richard L.; Lumry, William; Harris, James; Levy, Robyn; Stein, Mark; Forbes, Lisa; Cunningham-Rundles, Charlotte; Melamed, Isaac; Kobayashi, Ai Lan; Du, Wei; Kobayashi, Roger
Title: Efficacy, Safety, and Pharmacokinetics of a New 10 % Liquid Intravenous Immunoglobulin Containing High Titer Neutralizing Antibody to RSV and Other Respiratory Viruses in Subjects with Primary Immunodeficiency Disease Document date: 2016_6_20
ID: 1mmn0f98_14
Snippet: Eligible subjects were male and female aged 2-75 years, inclusive with a confirmed diagnosis of primary immunodeficiency. Prior to enrollment, subjects were required to have received IVIG infusions every 3 or 4 weeks at a dose that had not been changed by >50 % of the mean dose on a mg/ kg basis for ≥3 months. Subjects were excluded if they had a history of adverse reactions to blood or blood-derived products, selective IgA deficiency, and hist.....
Document: Eligible subjects were male and female aged 2-75 years, inclusive with a confirmed diagnosis of primary immunodeficiency. Prior to enrollment, subjects were required to have received IVIG infusions every 3 or 4 weeks at a dose that had not been changed by >50 % of the mean dose on a mg/ kg basis for ≥3 months. Subjects were excluded if they had a history of adverse reactions to blood or blood-derived products, selective IgA deficiency, and history of allergic reaction to products containing IgA or antibodies to IgA, abnormal liver function, deep vein thrombosis, hemolysis, or positive Coombs test or were pregnant or lactating.
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