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Immune Globulin Intravenous (Human), 10%

BIOLOGICAL6 trials

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID), Baxalta now part of Shire, University of Alberta

Conditions

Hypogammaglobulinemia, AcquiredImmune Thrombocytopenic Purpura (ITP)Kawasaki SyndromeKidney Failure, ChronicMultifocal Motor NeuropathyPrimary Immunodeficiency Diseases (PID)

Phase 2

Improving Transplant Options of Highly Sensitized Recipients Using IGIV-C, 10%
TerminatedNCT00090194
National Institute of Allergy and Infectious Diseases (NIAID)Kidney Failure, Chronic
Start: 2003-06-30End: 2004-03-31Updated: 2017-01-11
Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects
CompletedNCT00546871
Baxalta now part of ShirePrimary Immunodeficiency Diseases (PID)
Start: 2007-10-03End: 2009-09-01Updated: 2021-05-19
Immune Globulin Subcutaenous (Human), 20%
CompletedNCT01412385
Baxalta now part of ShirePrimary Immunodeficiency Diseases (PID)
Start: 2011-06-20End: 2014-05-13Updated: 2021-05-05

Phase 3

Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders
CompletedNCT00157079
Baxalta now part of ShireImmune Thrombocytopenic Purpura (ITP), Kawasaki Syndrome, Primary Immunodeficiency Diseases (PID)
Start: 2002-06-25End: 2003-12-16Updated: 2021-08-24
Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy
CompletedNCT00666263
Baxalta now part of ShireMultifocal Motor Neuropathy
Start: 2008-08-22End: 2011-08-11Updated: 2021-05-19

Unknown Phase

Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy
RecruitingNCT06989541
University of AlbertaHypogammaglobulinemia, Acquired
Start: 2025-06-01End: 2027-05-01Target: 30Updated: 2025-07-03

Related Papers

Dose, exposure, and treatment regimen of intravenous immunoglobulin G in multifocal motor neuropathy
Frontiers in Neurology2024-11-06
Dose–exposure–efficacy response of intravenous immunoglobulin G 10% in multifocal motor neuropathy
Annals of Clinical and Translational Neurology2024-07-081 citations
Pharmacokinetics, safety, and efficacy of 20% subcutaneous immunoglobulin (Ig20Gly) administered weekly or every 2 weeks in Japanese patients with primary immunodeficiency diseases: a phase 3, open-label study
Immunotherapy Advances2024-01-011 citations
Real-World Use, Safety, and Patient Experience of 20% Subcutaneous Immunoglobulin for Primary Immunodeficiency Diseases.
2023-09-266 citations
Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study.
2022-08-0710 citations
Infection Rates and Tolerability of Three Different Immunoglobulin Administration Modalities in Patients with Primary Immunodeficiency Diseases
Immunotherapy2021-12-214 citations
Population pharmacokinetic simulation of varied Immune Globulin Subcutaneous (Human), 20% solution (Ig20Gly) loading and maintenance dosing regimens in immunoglobulin-naïve patients with primary immunodeficiency diseases.
2021-10-016 citations
Steady-State Serum IgG Trough Levels Are Adequate for Pharmacokinetic Assessment in Patients with Immunodeficiencies Receiving Subcutaneous Immune Globulin.
2021-05-263 citations