biostudies-literatureUnknown43(3)Krivan G<h4>Purpose</h4>To assess the efficacy, pharmacokinetics, and safety of a new, highly purified 10% IVIg (BT595, Yimmugo^®) administered in children with PID.<h4>Methods</h4>This was an open-label, prospective, uncontrolled, multicenter Phase III pivotal trial. Among the 67 subjects in the trial were 18 pediatric patients aged 2 to 17 years with diagnosis of PID included in this analysis. They received doses between 0.2 and 0.8 g/kg body weight for approximately 12 months at intervals of either 3 or 4 weeks. Dosage and dosing interval were based on each patient's pre-trial infusion schedule. The rates of acute serious bacterial infections (SBI), secondary efficacy, safety, and pharmacokinetic outcomes were evaluated.<h4>Results</h4>No SBI occurred in the pediatric population. Two Journal of clinical immunology557-567https://www.ebi.ac.uk/biostudies/studies/S-EPMC9958146biostudies-literatureBT595, a 10% Human Normal Immunoglobulin, for Replacement Therapy of Primary Immunodeficiency Disease: Results of a Subcohort Analysis in Children.PMC9958146Borte MLentze SMelamed IRSoler-Palacin PHarris JBCsurke ISimon RStaiger CAigner SMoy JNChurch JALieberman JAKrivan GfalseBT595, a 10% Human Normal Immunoglobulin, for Replacement Therapy of Primary Immunodeficiency Disease: Results of a Subcohort Analysis in Children.<h4>Purpose</h4>To assess the efficacy, pharmacokinetics, and safety of a new, highly purified 10% IVIg (BT595, Yimmugo^®) administered in children with PID.<h4>Methods</h4>This was an open-label, prospective, uncontrolled, multicenter Phase III pivotal trial. Among the 67 subjects in the trial were 18 pediatric patients aged 2 to 17 years with diagnosis of PID included in this analysis. They received doses between 0.2 and 0.8 g/kg body weight for approximately 12 months at intervals of either 3 or 4 weeks. Dosage and dosing interval were based on each patient's pre-trial infusion schedule. The rates of acute serious bacterial infections (SBI), secondary efficacy, safety, and pharmacokinetic outcomes were evaluated.<h4>Results</h4>No SBI occurred in the pediatric population. Two 2023-01-01T00:00:00Z2023 Apr2025-04-05T11:42:17.464Z2024-12-04T13:31:43.094ZS-EPMC99581463638329410.1007/s10875-022-01397-0