biostudies-literatureUnknown42(3)Santamaria M<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. TJournal of clinical immunology500-511https://www.ebi.ac.uk/biostudies/studies/S-EPMC9016006biostudies-literatureA Multi‑Center, Open‑Label, Single‑Arm Trial to Evaluate the Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency.PMC9016006Douglass JABorte MPrice JKobbe RSonnenschein ANeth OAlsina LKralickova PRamon SSChandra AQuerolt MBernatowska EGrigoriadou SBethune CHames CGonzalez-Granado LIHorneff GSanz AGriffin RMondou ELin JLangguth DSantamaria MKrivan GfalseA Multi‑Center, Open‑Label, Single‑Arm Trial to Evaluate the Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency.<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. T2022-01-01T00:00:00Z2022 Apr2026-05-31T01:07:20.881Z2025-04-04T11:31:28.86ZS-EPMC90160063497314310.1007/s10875-021-01181-6