Drugs / Immune Globulin

Trials 15

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial · 1 missed
Phase 0 NCT00460928 Apr 2007 → Jun 2009 congenital heart block, neonatal lupus erythematosus NYU Langone Health Completed Missed primary
Phase 11 trial
Phase 1 NCT00195637 Sep 2005 → Jul 2006 hereditary inclusion-body myopathy National Human Genome Research Institute (NHGRI) Completed No outcome recorded
Phase 21 trial
Phase 2 NCT05952804 Jun 2024 → Jul 2028 expected hematopoietic and lymphoid cell neoplasm Fred Hutchinson Cancer Center Recruiting No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT07202078 May 2025 → Mar 2027 expected leukemia, non-Hodgkin lymphoma, plasma cell myeloma Monash University Recruiting No outcome recorded
Phase 2/3 NCT07202091 May 2025 → Mar 2027 expected leukemia, non-Hodgkin lymphoma, plasma cell myeloma Monash University Recruiting No outcome recorded
Phase 2/3 NCT01218438 Jan 2013 → Mar 2015 immunodeficiency disease Baxalta now part of Shire Completed No outcome recorded
Phase 36 trials
Phase 3 NCT04346108 Aug 2020 → Dec 2021 immunodeficiency disease Baxalta now part of Shire Completed No outcome recorded
Phase 3 NCT03166527 Jun 2017 → Dec 2018 polyneuropathy, inflammatory demyelinating, chronic Vera Bril Unknown No outcome recorded
Phase 3 NCT01992328 Dec 2013 → Jan 2017 asthma Ajou University School of Medicine Unknown No outcome recorded
Phase 3 NCT00004286 Feb 1996 → Nov 1999 chronic inflammatory demyelinating polyradiculoneuropathy National Center for Research Resources (NCRR) Completed No outcome recorded
Phase 3 NCT00004744 Feb 1993 → Sep 1998 multiple sclerosis National Institute of Neurological Disorders and Stroke (NINDS) Completed No outcome recorded
Phase 3 NCT00004772 Sep 1992 → ? chronic inflammatory demyelinating polyradiculoneuropathy National Center for Research Resources (NCRR) Completed No outcome recorded
Phase not applicable3 trials
— NCT00004407 Feb 1998 → Mar 2000 diabetic neuropathy Mayo Clinic Terminated No outcome recorded
— NCT00004833 Jul 1995 → Nov 2002 Guillain-Barre syndrome Emory University Terminated No outcome recorded
— NCT00004682 Mar 1995 → Mar 1999 myasthenia gravis University of Texas Terminated No outcome recorded

Press releases naming this drug 17 releases

DateIssuerRelease
2024-07-29 Grifols Therapeutics LLC Grifols receives expanded XEMBIFY® (immune globulin subcutaneous human-klhw) label in U.S., strengthening its Ig portfolio for patients grifols.com ↗
2024-01-03 CSL Behring CSL Behring Announces Availability of Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 10g Prefilled Syringe csl.com ↗
2023-09-25 Takeda Takeda Announces Approval of CUVITRU Subcutaneous Immunoglobulin in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia takeda.com ↗
2023-07-20 Grifols Therapeutics LLC Grifols achieves positive topline results from phase 4 study of XEMBIFY® (immune globulin subcutaneous human-klhw) evaluating biweekly dosing option for patients grifols.com ↗
2021-08-25 Emergent BioSolutions Emergent BioSolutions’ COVID-19 Human Immune Globulin Product Candidate to be Evaluated in NIH-Sponsored Phase 3 Clinical Trial (INSIGHT-012) of Hyperimmune Intravenous Immunoglobulin for Outpatient Treatment of COVID-19 emergentbiosolutions.com ↗
2020-12-09 CSL Behring HIZENTRA® (Immune Globulin Subcutaneous [Human] 20% Liquid) Receives Orphan-Drug Exclusivity for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
2020-10-08 Emergent BioSolutions Emergent BioSolutions’ COVID-19 Human Immune Globulin Product Candidate to be Included in NIH-Sponsored Phase 3 Clinical Trial of Hyperimmune Intravenous Immunoglobulin to Treat COVID-19 emergentbiosolutions.com ↗
2017-11-09 CSL Behring Lancet Neurology Publishes Results from CSL Behring Phase III Study of Hizentra® (Immune Globulin Subcutaneous [Human] 20% liquid) as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
2017-09-14 CSL Behring CSL Behring Announces FDA Approval of Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults csl.com ↗
2017-03-06 Takeda CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] Data Demonstrate Improved Treatment Satisfaction Relative to Patients’ Previous Immunoglobulin Therapy takeda.com ↗
2016-11-16 Takeda Shire launches CUVITRU™ [Immune Globulin Subcutaneous (Human), 20% Solution] in the U.S. for Primary Immunodeficiency takeda.com ↗
2016-11-12 Takeda Tolerability Data for Shire’s Cuvitru Accepted for Oral Presentation at the American College Of Allergy, Asthma & Immunology Annual Meeting takeda.com ↗

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 17 sources stand behind the page.

FieldValueCited text
Known as immune globulin ClinicalTrials.gov intervention name — accepted as the source's own label NCT00460928 ↗
14

NCT00004286 ↗

NCT07202091 ↗

NCT07202078 ↗

NCT05952804 ↗

NCT00004833 ↗

NCT01218438 ↗

NCT00004407 ↗

NCT03166527 ↗

NCT00195637 ↗

NCT00004772 ↗

Show 4 more sources

Known as Cuvitru “weekly 20% subcutaneous IG (SCIG; Cuvitru, Ig20Gly)” PMID 34036490 ↗ May 2021
Known as human immunoglobulin “human immunoglobulin infusion (IVIg)” NCT00004833 ↗
Known as Ig20Gly “weekly 20% subcutaneous IG (SCIG; Cuvitru, Ig20Gly)” PMID 34036490 ↗ May 2021
Known as IGIV “Immune Globulin Intravenous (IGIV)” NCT04346108 ↗
Known as IGSC “Immune Globulin Subcutaneous, 20% Solution (IGSC, 20%)” NCT04346108 ↗
Known as intravenous immunoglobulin “Determine the effect of intravenous immunoglobulin on recovery time of patients with proximal diabetic neuropathy.” NCT00004407 ↗
Known as IVIG “In this open-label pilot study, we propose to provide free sialic acid to muscle cells of HIBM patients by intravenous infusions of immune globulin (IvIg), a glycoprotein that...” NCT00195637 ↗
5

“treating the pregnant mother with intravenous immune globulin (IVIG) will prevent the development of CHB” NCT00460928 ↗

“intravenous human immune globulin (IVIG) or placebo” NCT00004286 ↗

“high-dose intravenous immune globulin (IVIG)” NCT00004744 ↗

“human immunoglobulin infusion (IVIg)” NCT00004833 ↗

“intravenous immune globulin (IVIG)” NCT00004772 ↗

Action Restore “life-long intravenous (IV) or subcutaneous (SC) immunoglobulin (Ig) replacement therapy” PMID 27582171 ↗ Aug 2016
Modality Protein / enzyme biologic “intravenous human immune globulin (IVIG)” NCT00004286 ↗
Route Intravenous “intravenous human immune globulin (IVIG)” NCT00004286 ↗