دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | Santamaria, Manuel, Neth, Olaf, Douglass, Jo A, Krivan, Gergely, Kobbe, Robin, Bernatowska, Ewa, Grigoriadou, Sofia, Bethune, Claire, Chandra, Anita, Horneff, Gerd, Borte, Michael, Sonnenschein, Anja, Kralickova, Pavlina, Ramón, Silvia Sánchez, Langguth, Daman, Gonzalez-Granado, Luis Ignacio, Alsina, Laia, Querolt, Montse, Griffin, Rhonda, Hames, Carrie, Mondou, Elsa, Price, Jeffrey, Sanz, Ana, Lin, Jiang |
| سنة النشر: | 2022 |
| المجموعة: | Sistema Sanitario Público de Andalucía (SSPA): Repositorio |
| مصطلحات موضوعية: | 20% immunoglobulin, GTI1503, Primary immunodeficiency, immunoglobulin replacement therapy, subcutaneous, Adolescent, Adult, Child, Humans, Immunoglobulin G, Immunoglobulins, Intravenous, Immunologic Deficiency Syndromes, Immunologic Factors, Infusions |
| الوصف: | 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). 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 Sixty-one subjects (19 children [≤ 12 years], 10 adolescents [> 12-16 years], and 32 adults) were enrolled. The rate of SBIs per person per year was 0.017. The 1-sided 99% upper confidence limit was 0.036 ( 12-16 years], and 32 adults) were enrolled. The rate of SBIs per person per year was 0.017. The 1-sided 99% upper confidence limit was 0.036 ( IGSC 20% demonstrated efficacy and good safety and tolerability in subjects with PI. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1573-2592 |
| العلاقة: | http://hdl.handle.net/10668/20596Test; PMC9016006; https://link.springer.com/content/pdf/10.1007/s10875-021-01181-6.pdfTest; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9016006/pdfTest |
| DOI: | 10.1007/s10875-021-01181-6 |
| DOI: | 10.1007/s10875-021-01181-6.pdf |
| الإتاحة: | https://doi.org/10.1007/s10875-021-01181-6Test http://hdl.handle.net/10668/20596Test https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9016006/pdfTest |
| حقوق: | Attribution 4.0 International ; http://creativecommons.org/licenses/by/4.0Test/ ; open access |
| رقم الانضمام: | edsbas.B5A57875 |
| قاعدة البيانات: | BASE |
| تدمد: | 15732592 |
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| DOI: | 10.1007/s10875-021-01181-6 |