{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["43(3)"],"submitter":["Krivan G"],"pubmed_abstract":["<h4>Purpose</h4>To assess the efficacy, pharmacokinetics, and safety of a new, highly purified 10% IVIg (BT595, Yimmugo<sup>®</sup>) 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":["Journal of clinical immunology"],"pagination":["557-567"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9958146"],"repository":["biostudies-literature"],"pubmed_title":["BT595, a 10% Human Normal Immunoglobulin, for Replacement Therapy of Primary Immunodeficiency Disease: Results of a Subcohort Analysis in Children."],"pmcid":["PMC9958146"],"pubmed_authors":["Borte M","Lentze S","Melamed IR","Soler-Palacin P","Harris JB","Csurke I","Simon R","Staiger C","Aigner S","Moy JN","Church JA","Lieberman JA","Krivan G"],"additional_accession":[]},"is_claimable":false,"name":"BT595, a 10% Human Normal Immunoglobulin, for Replacement Therapy of Primary Immunodeficiency Disease: Results of a Subcohort Analysis in Children.","description":"<h4>Purpose</h4>To assess the efficacy, pharmacokinetics, and safety of a new, highly purified 10% IVIg (BT595, Yimmugo<sup>®</sup>) 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 ","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Apr","modification":"2025-04-05T11:42:17.464Z","creation":"2024-12-04T13:31:43.094Z"},"accession":"S-EPMC9958146","cross_references":{"pubmed":["36383294"],"doi":["10.1007/s10875-022-01397-0"]}}