{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["42(3)"],"submitter":["Santamaria M"],"pubmed_abstract":["<h4>Purpose</h4>The purpose of this phase 3 study was to evaluate the efficacy, pharmacokinetics (PK), and safety of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) in patients with primary immunodeficiency (PI).<h4>Methods</h4>Immunoglobulin treatment-experienced subjects with PI received 52 weeks of IGSC 20% given weekly at the same dose as the subject's previous IgG regimen (DAF 1:1); the minimum dose was 100 mg/kg/week. The primary endpoint was serious bacterial infections (SBIs [null vs alternative hypothesis: SBI rate per person per year ≥ 1 vs < 1]). IgG subclasses and specific pathogen antibody levels were also measured.<h4>Results</h4>Sixty-one subjects (19 children [≤ 12 years], 10 adolescents [> 12-16 years], and 32 adults) were enrolled. T"],"journal":["Journal of clinical immunology"],"pagination":["500-511"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9016006"],"repository":["biostudies-literature"],"pubmed_title":["A Multi‑Center, Open‑Label, Single‑Arm Trial to Evaluate the Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency."],"pmcid":["PMC9016006"],"pubmed_authors":["Douglass JA","Borte M","Price J","Kobbe R","Sonnenschein A","Neth O","Alsina L","Kralickova P","Ramon SS","Chandra A","Querolt M","Bernatowska E","Grigoriadou S","Bethune C","Hames C","Gonzalez-Granado LI","Horneff G","Sanz A","Griffin R","Mondou E","Lin J","Langguth D","Santamaria M","Krivan G"],"additional_accession":[]},"is_claimable":false,"name":"A Multi‑Center, Open‑Label, Single‑Arm Trial to Evaluate the Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency.","description":"<h4>Purpose</h4>The purpose of this phase 3 study was to evaluate the efficacy, pharmacokinetics (PK), and safety of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) in patients with primary immunodeficiency (PI).<h4>Methods</h4>Immunoglobulin treatment-experienced subjects with PI received 52 weeks of IGSC 20% given weekly at the same dose as the subject's previous IgG regimen (DAF 1:1); the minimum dose was 100 mg/kg/week. The primary endpoint was serious bacterial infections (SBIs [null vs alternative hypothesis: SBI rate per person per year ≥ 1 vs < 1]). IgG subclasses and specific pathogen antibody levels were also measured.<h4>Results</h4>Sixty-one subjects (19 children [≤ 12 years], 10 adolescents [> 12-16 years], and 32 adults) were enrolled. T","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Apr","modification":"2026-05-31T01:07:20.881Z","creation":"2025-04-04T11:31:28.86Z"},"accession":"S-EPMC9016006","cross_references":{"pubmed":["34973143"],"doi":["10.1007/s10875-021-01181-6"]}}