Drugs / Gamunex-C
Gamunex-C
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT04450654 | May → Jul 2022 | immune-mediated necrotizing myopathy | University of Washington | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04480424 | Sep 2020 → Aug 2021 | COVID-19 | Grifols Therapeutics LLC | Completed | Missed primary |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT07582432 | Apr 2026 → Aug 2028 expected | B-cell neoplasm | Grifols Biologicals, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07540221 | Apr 2026 → Dec 2027 expected | chronic inflammatory demyelinating polyradiculoneuropathy | Grifols Therapeutics LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT02549170 | Dec 2015 → Feb 2022 | chronic inflammatory demyelinating polyradiculoneuropathy | Baxalta now part of Shire | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT01465958 | Nov 2011 → Oct 2013 | immunodeficiency disease | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT02042027 Comparator | Jul 2014 → Jul 2016 | corneal neovascularization, uveitis | University of Utah | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04561115 Comparator | Sep 2020 → Mar 2022 | immunodeficiency disease | Grifols Therapeutics LLC | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GAMUNEX-C | “Subcutaneous Immune Globulin Injection (Human), 10 % Caprylate/Chromatography Purified (GAMUNEX®-C) in Pediatric Patients with Primary Immunodeficiency Disease.” PMID 27342758 ↗ Jun 20169“Gamunex®-C Plus Standard Medical Treatment to Prevent Infections” NCT07582432 ↗ |
| Known as | IGIV-C | “subcutaneously (SC) administered 10 % caprylate/chromatography purified human immune globulin injection (IGIV-C, GAMUNEX®) compared with intravenously (IV) administered IGIV-C.” PMID 27342758 ↗ Jun 2016 |
| Known as | IGIV-C 10% | “Gamunex-C (IGIV-C 10%)” NCT07540221 ↗ |
| Modality | Protein / enzyme biologic | “10 % caprylate/chromatography purified human immune globulin injection (IGIV-C, GAMUNEX®)” PMID 27342758 ↗ Jun 2016 |
| Route | Intravenous | “intravenously (IV; through the vein) administered GAMUNEX-C” NCT01465958 ↗ |