Drugs / IGIV-C
IGIV-C
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT02915263 | Sep 2017 → Feb 2022 | diabetes mellitus, diabetic neuropathy | Beth Israel Deaconess Medical Center | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02473952 | Aug 2015 → Jan 2018 | generalized myasthenia gravis | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT02473965 | Jun 2015 → Feb 2019 | generalized myasthenia gravis | Grifols Therapeutics LLC | Completed | Missed primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT02413580 | Mar 2015 → Apr 2018 | myasthenia gravis | Grifols Therapeutics LLC | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT02604810 Comparator | Jan 2016 → Sep 2017 | immunodeficiency disease | Grifols Therapeutics LLC | Completed | Met primary |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IGIV-C | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02413580 ↗ |
| Known as | Immune Globulin (Human), 10% Caprylate/Chromatography Purified | “This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified...” NCT02473965 ↗1“A Multicenter, Prospective, Open-label, Non-controlled Clinical Trial to Assess the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified...” NCT02413580 ↗ |
| Known as | immune globulin injection (human) | “This prospective, Phase III study assessed the pharmacokinetics (PK), safety and tolerability of immune globulin subcutaneous, human - klhw 20% solution (IGSC-C 20%) in...” PMID 31621458 ↗ Oct 2019 |
| Known as | Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified | “IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified” NCT02473952 ↗ |
| Known as | IVIg-C | “Immune globulin 10% caprylate/chromatography purified (IVIg-C)” PMID 35350948 ↗ Apr 2022 |
| Modality | Protein / enzyme biologic | “Immune Globulin (Human), 10% Caprylate/Chromatography Purified” NCT02413580 ↗ |
| Route | Intravenous | “An IV dose of 2 g/kg of IGIV-C was administered over 2 consecutive days at a dose of 1 g/kg per day.” NCT02413580 ↗ |