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_26
Snippet: A total of 75 subjects were screened and 59 subjects, 28 males and 31 females, were enrolled and received at least 1 RI-002 infusion (mITT population). The majority of study subjects were Caucasian (98.3 %), average age was 41.8 years ranging from 3 to 73 years. The study included 48 adult subjects (>16 years of age) and 11 pediatric subjects. The most common PIDD type was common variable immunodeficiency (CVID) in 45 subjects (76.3 % of the subj.....
Document: A total of 75 subjects were screened and 59 subjects, 28 males and 31 females, were enrolled and received at least 1 RI-002 infusion (mITT population). The majority of study subjects were Caucasian (98.3 %), average age was 41.8 years ranging from 3 to 73 years. The study included 48 adult subjects (>16 years of age) and 11 pediatric subjects. The most common PIDD type was common variable immunodeficiency (CVID) in 45 subjects (76.3 % of the subjects). Mean time from diagnosis to study enrollment was 8.66 years (ranged from 0.3 to 32.9 years). Demographic characteristics were similar between the two regimens (Table 1) .
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