Gamunex-c (DrugBank: -)
1 disease告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
65 | 原発性免疫不全症候群 | 2 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | NCT04561115 (ClinicalTrials.gov) | October 6, 2020 | 10/9/2020 | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency | A Phase 3, Multicenter, Open-label, Single-sequence, Cross-over, Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of IVIG-PEG Compared to Gamunex-C in Subjects With Primary Humoral Immunodeficiency | Primary Immunodeficiency | Biological: Gamunex-C;Biological: IVIG-PEG | Grifols Therapeutics LLC | NULL | Recruiting | 18 Years | 75 Years | All | 25 | Phase 3 | United States |
2 | NCT01465958 (ClinicalTrials.gov) | November 2011 | 24/10/2011 | Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency | An Open-label, Single-sequence, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Subcutaneous GAMUNEX®-C in Pediatric Subjects With Primary Immunodeficiency | Primary Immunodeficiency | Biological: GAMUNEX-C | Grifols Therapeutics Inc. | NULL | Completed | 2 Years | 16 Years | All | 12 | Phase 4 | United States |