{"id":"gamunex-intravenous-immunoglobulin","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Thrombosis (rare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"IVIG works by delivering a broad spectrum of immunoglobulins (primarily IgG) from pooled human plasma donors, which can neutralize pathogens, opsonize antigens for clearance, and modulate immune responses through Fc receptor engagement and complement inhibition. This mechanism supports both antibody-deficient patients and those with dysregulated immune responses. The product is used in immunodeficiency disorders and certain autoimmune/inflammatory conditions.","oneSentence":"Gamunex is an intravenous immunoglobulin (IVIG) that provides passive immunity by supplying pooled human antibodies to enhance immune function and modulate inflammatory responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:13:43.151Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders"},{"name":"Secondary immunodeficiency"},{"name":"Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy)"}]},"trialDetails":[{"nctId":"NCT06290141","phase":"PHASE3","title":"A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","status":"RECRUITING","sponsor":"Sanofi","startDate":"2024-08-21","conditions":"Chronic Inflammatory Demyelinating Polyneuropathy","enrollment":160},{"nctId":"NCT06980480","phase":"PHASE3","title":"A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma","status":"RECRUITING","sponsor":"Takeda","startDate":"2026-01-14","conditions":"Multiple Myeloma, Secondary Immunodeficiency","enrollment":183},{"nctId":"NCT06859424","phase":"PHASE2","title":"A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation","status":"RECRUITING","sponsor":"Center for International Blood and Marrow Transplant Research","startDate":"2025-07-25","conditions":"AML (Acute Myelogenous Leukemia), Acute Lymphoid Leukemia (ALL), Acute Leukemia (Category)","enrollment":358},{"nctId":"NCT04850456","phase":"","title":"Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm","status":"RECRUITING","sponsor":"Children's Hospital of Fudan University","startDate":"2024-10-01","conditions":"Critical Illness, Sepsis, Severe","enrollment":200},{"nctId":"NCT07475624","phase":"","title":"Determinants of Digestive Morbidity in Neonatal Jaundice","status":"COMPLETED","sponsor":"The First Hospital of Jilin University","startDate":"2019-12-01","conditions":"Digestive","enrollment":3218},{"nctId":"NCT07299695","phase":"PHASE3","title":"Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis","status":"RECRUITING","sponsor":"Argyrios Tzouvelekis","startDate":"2026-01-25","conditions":"Idiopathic Pulmonary Fibrosis, Acute Exacerbation of Idiopathic Pulmonary Fibrosis","enrollment":196},{"nctId":"NCT06533098","phase":"PHASE3","title":"A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)","status":"RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2025-02-10","conditions":"Thrombocytopenia, Neonatal Alloimmune","enrollment":50},{"nctId":"NCT06752356","phase":"PHASE3","title":"A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","status":"RECRUITING","sponsor":"Kedrion S.p.A.","startDate":"2026-04","conditions":"Chronic Inflammatory Demyelinating Polyneuropathy","enrollment":161},{"nctId":"NCT06742190","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy","status":"RECRUITING","sponsor":"argenx","startDate":"2024-12-18","conditions":"Multifocal Motor Neuropathy (MMN), MMN","enrollment":115},{"nctId":"NCT07410039","phase":"PHASE4","title":"Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study","status":"RECRUITING","sponsor":"Chinese PLA General Hospital","startDate":"2026-02-01","conditions":"Neuromyelitis Optica Spectrum Disorder Attack","enrollment":200},{"nctId":"NCT05701189","phase":"PHASE2","title":"Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome","status":"WITHDRAWN","sponsor":"Chafic Karam","startDate":"2024-09-10","conditions":"Guillain-Barre Syndrome","enrollment":""},{"nctId":"NCT03876288","phase":"","title":"Gastroparesis Outcome Longitudinal Database Enrolled Numerically","status":"RECRUITING","sponsor":"University of Louisville","startDate":"2013-01-01","conditions":"Gastroparesis","enrollment":3000},{"nctId":"NCT06918990","phase":"PHASE2","title":"Treatment of Antibody-Mediated Rejection (ABMR) With CarBel","status":"NOT_YET_RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2026-04-15","conditions":"Kidney Transplant Rejection","enrollment":25},{"nctId":"NCT04609761","phase":"PHASE2","title":"Open-label Trial of IVIG in Children With PANS","status":"COMPLETED","sponsor":"Göteborg University","startDate":"2021-01-12","conditions":"PANS Pediatric Acute-Onset Neuropsychiatric Syndrome","enrollment":17},{"nctId":"NCT06920004","phase":"PHASE3","title":"A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP","status":"RECRUITING","sponsor":"argenx","startDate":"2025-08-22","conditions":"Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy","enrollment":218},{"nctId":"NCT05350774","phase":"PHASE2","title":"Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2","status":"ENROLLING_BY_INVITATION","sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","startDate":"2023-07-10","conditions":"Systemic Inflammation, Neuroinflammation, Microvascular Thrombosis","enrollment":45},{"nctId":"NCT03849651","phase":"PHASE2","title":"TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2019-01-31","conditions":"Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS)","enrollment":69},{"nctId":"NCT05832034","phase":"PHASE2, PHASE3","title":"Add-on Intravenous Immunoglobulins in Early Myositis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2021-09-13","conditions":"Inflammatory Myopathy, Idiopathic, Dermatomyositis, Antisynthetase Syndrome","enrollment":44},{"nctId":"NCT04438382","phase":"PHASE2","title":"Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis","status":"TERMINATED","sponsor":"ECOG-ACRIN Cancer Research Group","startDate":"2021-01-07","conditions":"Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Steroid-Refractory Pneumonitis","enrollment":1},{"nctId":"NCT05662228","phase":"PHASE2","title":"Therapies for Down Syndrome Regression Disorder","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Colorado, Denver","startDate":"2023-06-29","conditions":"Down Syndrome, Regression","enrollment":66},{"nctId":"NCT06599697","phase":"PHASE2","title":"The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy","status":"RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2025-10-27","conditions":"Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy","enrollment":12},{"nctId":"NCT05156710","phase":"PHASE2","title":"BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2022-06-09","conditions":"Transplant Rejection","enrollment":48},{"nctId":"NCT03286556","phase":"PHASE2","title":"Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis","status":"COMPLETED","sponsor":"University of Alabama at Birmingham","startDate":"2018-09-04","conditions":"Idiopathic Pulmonary Fibrosis, Acute Fatal Form","enrollment":82},{"nctId":"NCT06565078","phase":"","title":"A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency","status":"RECRUITING","sponsor":"Takeda","startDate":"2025-02-17","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":100},{"nctId":"NCT04818177","phase":"","title":"Immunoglobulin G Therapy Dose Optimization","status":"COMPLETED","sponsor":"Rutgers, The State University of New Jersey","startDate":"2021-04-01","conditions":"Obesity, Immune Deficiency","enrollment":40},{"nctId":"NCT04356781","phase":"","title":"Do IgG Level Variations in CIDP and MMN Patients Following Initial Intravenous IVIg Treatment Correlate With Ultimate Dosing","status":"COMPLETED","sponsor":"Walton Centre NHS Foundation Trust","startDate":"2020-09-28","conditions":"Multifocal Motor Neuropathy (MMN), Chronic Inflammatory Demyelinating Polyradiculoneuropathy","enrollment":20},{"nctId":"NCT02201576","phase":"PHASE2","title":"Bortezomib in Rejection of Kidney Transplants","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2015-02-11","conditions":"Chronic Antibody-mediated Transplant Rejection","enrollment":60},{"nctId":"NCT06637072","phase":"PHASE4","title":"A Study to Assess Adults With CIDP Transitioning From IVIg to Efgartigimod PH20 SC","status":"ACTIVE_NOT_RECRUITING","sponsor":"argenx","startDate":"2024-12-10","conditions":"Chronic Inflammatory Demyelinating Polyneuropathy","enrollment":23},{"nctId":"NCT03569553","phase":"","title":"A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients","status":"NOT_YET_RECRUITING","sponsor":"Emergent BioSolutions","startDate":"2027-05-30","conditions":"Inhalational Anthrax","enrollment":100},{"nctId":"NCT03569514","phase":"","title":"Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax","status":"NOT_YET_RECRUITING","sponsor":"Emergent BioSolutions","startDate":"2026-11-30","conditions":"Anthrax","enrollment":10},{"nctId":"NCT05755035","phase":"PHASE2, PHASE3","title":"A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases","status":"COMPLETED","sponsor":"Takeda","startDate":"2023-10-24","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":65},{"nctId":"NCT05952804","phase":"PHASE2","title":"IVIG for Infection Prevention After CAR-T-Cell Therapy","status":"RECRUITING","sponsor":"Fred Hutchinson Cancer Center","startDate":"2024-06-10","conditions":"Hematologic Malignancies","enrollment":150},{"nctId":"NCT06925360","phase":"PHASE2","title":"IVIG Trial for the Treatment of Bronchopulmonary Dysplasia","status":"RECRUITING","sponsor":"International Peace Maternity and Child Health Hospital","startDate":"2025-04-12","conditions":"Bronchopulmonary Dysplasia","enrollment":20},{"nctId":"NCT04910269","phase":"PHASE3","title":"Outpatient Treatment With Anti-Coronavirus Immunoglobulin","status":"RECRUITING","sponsor":"University of Minnesota","startDate":"2021-08-06","conditions":"COVID, SARS-CoV2 Infection, Covid19","enrollment":820},{"nctId":"NCT06747351","phase":"PHASE3","title":"A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","status":"RECRUITING","sponsor":"Takeda","startDate":"2025-05-06","conditions":"Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","enrollment":59},{"nctId":"NCT06954441","phase":"PHASE3","title":"V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency","status":"RECRUITING","sponsor":"On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.","startDate":"2025-08-15","conditions":"Immunodeficiencies, Primary Immunodeficiencies (PID), Agammaglobulinemia","enrollment":50},{"nctId":"NCT03585946","phase":"","title":"Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis","status":"WITHDRAWN","sponsor":"Massachusetts General Hospital","startDate":"2030-01-01","conditions":"Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Reaction","enrollment":""},{"nctId":"NCT04944979","phase":"PHASE3","title":"Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kedrion S.p.A.","startDate":"2021-03-31","conditions":"Primary Immunodeficiency Disease","enrollment":30},{"nctId":"NCT03292861","phase":"PHASE2","title":"The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients","status":"ENROLLING_BY_INVITATION","sponsor":"Cedars-Sinai Medical Center","startDate":"2018-09-13","conditions":"Heart Transplantation","enrollment":60},{"nctId":"NCT04153422","phase":"PHASE2","title":"IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies","status":"RECRUITING","sponsor":"Endeavor Health","startDate":"2023-12-15","conditions":"Small Fiber Neuropathy, Autoimmune Small Fiber Neuropathy, Inflammatory Polyneuropathy","enrollment":20},{"nctId":"NCT01596335","phase":"PHASE3","title":"Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2012-05","conditions":"Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin","enrollment":31},{"nctId":"NCT04078568","phase":"PHASE3","title":"Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Hospital of Fudan University","startDate":"2020-01-15","conditions":"Kawasaki Disease","enrollment":3208},{"nctId":"NCT01757418","phase":"PHASE1, PHASE2","title":"Intravenous Gammaglobulin for Sickle Cell Pain Crises","status":"COMPLETED","sponsor":"Albert Einstein College of Medicine","startDate":"2008-11","conditions":"Sickle Cell Disease, Pain","enrollment":300},{"nctId":"NCT06958796","phase":"PHASE4","title":"Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)","status":"RECRUITING","sponsor":"Camille N. Kotton, MD","startDate":"2025-11-27","conditions":"Cytomegalovirus, Organ Transplant, Kidney Transplant; Complications","enrollment":80},{"nctId":"NCT07233213","phase":"PHASE3","title":"An Open-label Study of Intravenous Immunoglobulin (5%) for the Treatment of Primary Immune Thrombocytopenia","status":"RECRUITING","sponsor":"Grand Shuyang Life Sciences (Chengdu) Co., Ltd.","startDate":"2025-11-24","conditions":"Primary Immune Thrombocytopenia (ITP)","enrollment":36},{"nctId":"NCT04422912","phase":"PHASE1, PHASE2","title":"A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)","status":"RECRUITING","sponsor":"Cabaletta Bio","startDate":"2020-09-29","conditions":"Pemphigus Vulgaris","enrollment":40},{"nctId":"NCT05645107","phase":"PHASE3","title":"A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","status":"RECRUITING","sponsor":"Grifols Therapeutics LLC","startDate":"2022-12-26","conditions":"Hypogammaglobulinemia, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia","enrollment":386},{"nctId":"NCT07076446","phase":"PHASE4","title":"An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)","status":"RECRUITING","sponsor":"CSL Behring","startDate":"2025-07-15","conditions":"Primary Immunodeficiency","enrollment":8},{"nctId":"NCT05584631","phase":"PHASE1","title":"IVIG vs SCIG in CIDP","status":"RECRUITING","sponsor":"Rutgers, The State University of New Jersey","startDate":"2022-09-11","conditions":"CIDP, Immunoglobulin Deficiency, Chronic Inflammatory Demyelinating Polyneuropathy","enrollment":20},{"nctId":"NCT05494593","phase":"PHASE4","title":"A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)","status":"WITHDRAWN","sponsor":"Takeda","startDate":"2023-02-28","conditions":"Mucopolysaccharidosis (MPS), Hunter Syndrome","enrollment":""},{"nctId":"NCT02176863","phase":"PHASE2, PHASE3","title":"Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome","status":"TERMINATED","sponsor":"Instituto Grifols, S.A.","startDate":"2014-09-23","conditions":"Post-polio Syndrome","enrollment":191},{"nctId":"NCT04701034","phase":"PHASE2","title":"Intravenous Immunoglobulin and Prednisolone for RPL After ART.","status":"COMPLETED","sponsor":"Aalborg University Hospital","startDate":"2021-01-28","conditions":"Habitual Abortion, Recurrent Pregnancy Loss, Fertility Disorders","enrollment":80},{"nctId":"NCT07231523","phase":"PHASE3","title":"EFG vs IVIG in TAMG","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Zhongshan Hospital","startDate":"2025-12-01","conditions":"Efgartigimod, Intravenous Immunoglobulin, Myasthenia Gravis Associated With Thymoma","enrollment":64},{"nctId":"NCT06935266","phase":"PHASE1","title":"A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults","status":"COMPLETED","sponsor":"Takeda","startDate":"2025-04-22","conditions":"Healthy Volunteers","enrollment":64},{"nctId":"NCT03684018","phase":"PHASE4","title":"Two Dose Levels of Privigen in Pediatric CIDP","status":"RECRUITING","sponsor":"CSL Behring","startDate":"2019-02-28","conditions":"Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","enrollment":30},{"nctId":"NCT03630211","phase":"PHASE2","title":"Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis","status":"RECRUITING","sponsor":"Paul Szabolcs","startDate":"2018-07-31","conditions":"Systemic Sclerosis, Diffuse Sclerosis Systemic, Interstitial Lung Disease","enrollment":8},{"nctId":"NCT01374984","phase":"","title":"VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection","status":"ENROLLING_BY_INVITATION","sponsor":"Emergent BioSolutions","startDate":"2007-08","conditions":"Complication of Smallpox Vaccination","enrollment":100},{"nctId":"NCT07202091","phase":"PHASE2, PHASE3","title":"Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)","status":"RECRUITING","sponsor":"Monash University","startDate":"2025-05-06","conditions":"Myeloma, Leukemia, Non Hodgkin's Lymphoma","enrollment":900},{"nctId":"NCT07202052","phase":"PHASE2, PHASE3","title":"Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)","status":"RECRUITING","sponsor":"Monash University","startDate":"2025-05-06","conditions":"Myeloma, Non-Hodgkin's Lymphoma, Leukemia","enrollment":900},{"nctId":"NCT07202065","phase":"PHASE2, PHASE3","title":"Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)","status":"RECRUITING","sponsor":"Monash University","startDate":"2025-04-28","conditions":"Myeloma, Non Hodgkin's Lymphoma, Leukemia","enrollment":900},{"nctId":"NCT07202078","phase":"PHASE2, PHASE3","title":"Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)","status":"RECRUITING","sponsor":"Monash University","startDate":"2025-05-07","conditions":"Myeloma, Non Hodgkin's Lymphoma, Leukemia","enrollment":900},{"nctId":"NCT07193953","phase":"PHASE1","title":"Intravenous Immunoglobulin (IVIG) and Blood-Brain Barrier Disruption in Amyotrophic Lateral Sclerosis (ALS)","status":"RECRUITING","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2025-04-15","conditions":"Amyotrophic Lateral Sclerosis, ALS","enrollment":6},{"nctId":"NCT06753955","phase":"PHASE1","title":"Phase 1 Study of ART5803 Safety and PK After IVIG in Healthy Participants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Arialys Therapeutics","startDate":"2025-03-18","conditions":"Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody, Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody (Disorder), Autoimmune Encephalitis","enrollment":6},{"nctId":"NCT02219165","phase":"PHASE2","title":"Efficacy of IntraVenous ImmunoGlobulins in Toxic Shock Syndromes: a Paediatric Pilot Study","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","startDate":"2015-01-08","conditions":"Toxic Shock Syndrome","enrollment":30},{"nctId":"NCT06895967","phase":"PHASE1","title":"A Study of TAK-881 and HyQvia in Healthy Adults","status":"COMPLETED","sponsor":"Takeda","startDate":"2025-03-24","conditions":"Healthy Volunteers","enrollment":30},{"nctId":"NCT03700138","phase":"PHASE3","title":"Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies","status":"COMPLETED","sponsor":"University Hospital, Strasbourg, France","startDate":"2019-06-19","conditions":"Primary Sjögren's Syndrome Painful Sensory Neuropathies","enrollment":24},{"nctId":"NCT07107555","phase":"","title":"Necrotizing Soft Tissue Infections","status":"ENROLLING_BY_INVITATION","sponsor":"European Society for Trauma and Emergency Surgery","startDate":"2026-01-01","conditions":"Necrotizing Soft Tissue Infection, Fournier Gangrene, Sepsis","enrollment":480},{"nctId":"NCT04222023","phase":"PHASE4","title":"Intravenous Immunoglobulins for Prevention of BKV Infection in Kidney Transplant Recipients According to BKV Genotype-specific Neutralizing Antibody Titers at the Day of Transplantation.","status":"COMPLETED","sponsor":"University Hospital, Strasbourg, France","startDate":"2022-08-21","conditions":"Kidney Transplantation","enrollment":359},{"nctId":"NCT03939637","phase":"PHASE3","title":"Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children","status":"COMPLETED","sponsor":"Baylor College of Medicine","startDate":"2019-05-02","conditions":"Immune Thrombocytopenia","enrollment":122},{"nctId":"NCT04565015","phase":"PHASE3","title":"Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency","status":"ACTIVE_NOT_RECRUITING","sponsor":"GC Biopharma Corp","startDate":"2020-12-21","conditions":"Primary Immune Deficiency","enrollment":24},{"nctId":"NCT06305793","phase":"PHASE2","title":"RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kanecia Obie Zimmerman","startDate":"2024-03-11","conditions":"Long COVID, Long Coronavirus Disease 2019 (Covid19), Long Covid-19","enrollment":200},{"nctId":"NCT07068126","phase":"NA","title":"Management of Children With Persistent ITP, A Novel Approach","status":"RECRUITING","sponsor":"Assiut University","startDate":"2025-01-01","conditions":"Persistent Immune Thrombocytopenia","enrollment":20},{"nctId":"NCT04935177","phase":"PHASE3","title":"Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx","status":"COMPLETED","sponsor":"Hansa Biopharma AB","startDate":"2021-10-14","conditions":"Kidney Transplantation in Highly Sensitized Patients","enrollment":64},{"nctId":"NCT06867991","phase":"PHASE3","title":"Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis","status":"RECRUITING","sponsor":"The First People's Hospital of Changzhou","startDate":"2024-11-08","conditions":"Anti-N-Methyl-D-Aspartate Receptor Encephalitis","enrollment":200},{"nctId":"NCT04400994","phase":"PHASE2","title":"IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus","status":"ACTIVE_NOT_RECRUITING","sponsor":"The University of Hong Kong","startDate":"2020-06-20","conditions":"Pemphigus","enrollment":20},{"nctId":"NCT06989541","phase":"","title":"Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy","status":"RECRUITING","sponsor":"University of Alberta","startDate":"2025-06-01","conditions":"Hypogammaglobulinemia, Acquired","enrollment":30},{"nctId":"NCT07009548","phase":"PHASE4","title":"CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients","status":"ENROLLING_BY_INVITATION","sponsor":"Fernanda P Silveira, MD, MS","startDate":"2025-06-26","conditions":"Cytomegalovirus (CMV) Infection","enrollment":45},{"nctId":"NCT05325008","phase":"PHASE3","title":"A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients","status":"RECRUITING","sponsor":"The University of Queensland","startDate":"2023-08-18","conditions":"BK Viremia, Kidney Transplant Infection, Kidney Transplant Failure and Rejection","enrollment":280},{"nctId":"NCT03542279","phase":"NA","title":"CPI Combination Therapy for Autoimmune Encephalitis","status":"COMPLETED","sponsor":"Xuanwu Hospital, Beijing","startDate":"2020-11-25","conditions":"Autoimmune Encephalitis","enrollment":70},{"nctId":"NCT07004803","phase":"NA","title":"Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency","status":"RECRUITING","sponsor":"Dr. Hatice Dönmez","startDate":"2024-09-15","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":32},{"nctId":"NCT03866577","phase":"PHASE1, PHASE2","title":"Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients","status":"TERMINATED","sponsor":"Momenta Pharmaceuticals, Inc.","startDate":"2018-12-21","conditions":"Immune Thrombocytopenic Purpura (ITP)","enrollment":50},{"nctId":"NCT02205762","phase":"PHASE2, PHASE3","title":"LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis","status":"RECRUITING","sponsor":"North American Consortium for Histiocytosis","startDate":"2016-11-02","conditions":"Langerhans Cell Histiocytosis","enrollment":1400},{"nctId":"NCT06076642","phase":"PHASE3","title":"A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases","status":"RECRUITING","sponsor":"Takeda","startDate":"2024-11-04","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":39},{"nctId":"NCT06955793","phase":"","title":"Expanded Access to TAK-881 for Children and Teenagers With Primary Immunodeficiency Diseases in the USA","status":"AVAILABLE","sponsor":"Takeda","startDate":"","conditions":"Primary Immunodeficiency Diseases (PIDD)","enrollment":""},{"nctId":"NCT06949241","phase":"","title":"A Single Cycle of Intravenous Immunoglobulin as Adjuvant to Rituximab in Patients With Pemphigus: A Retrospective Cohort Study at a Tertiary Referral Center","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ruijin Hospital","startDate":"2019-12-01","conditions":"Pemphigus Disease, Rituximab (RTx), Intravenous Immunoglobulin","enrollment":76},{"nctId":"NCT04728425","phase":"PHASE2","title":"Subcutaneous Immunoglobulin for Myasthenia Gravis","status":"COMPLETED","sponsor":"University Health Network, Toronto","startDate":"2020-08-28","conditions":"Myasthenia Gravis","enrollment":30},{"nctId":"NCT03961009","phase":"PHASE3","title":"Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients","status":"COMPLETED","sponsor":"Kedrion S.p.A.","startDate":"2019-04-30","conditions":"Primary Immunodeficiency Disease","enrollment":47},{"nctId":"NCT03994783","phase":"PHASE3","title":"Transplant Antibody-Mediated Rejection: Guiding Effective Treatments","status":"TERMINATED","sponsor":"Imperial College London","startDate":"2019-07-17","conditions":"Kidney Transplant Rejection, Antibody-mediated Rejection","enrollment":3},{"nctId":"NCT03194815","phase":"PHASE2","title":"IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2","status":"RECRUITING","sponsor":"University of Cambridge","startDate":"2017-11-01","conditions":"Psychosis, Autoimmune Encephalitis","enrollment":70},{"nctId":"NCT06873672","phase":"","title":"Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China","status":"NOT_YET_RECRUITING","sponsor":"RenJi Hospital","startDate":"2025-04-01","conditions":"Quality of Life (QOL), Patient-Reported Outcome Measures (PROMs), Pneumonia Childhood","enrollment":360},{"nctId":"NCT05114941","phase":"NA","title":"Comparison of the Efficacy and Safety of Immunoadsorption and Intravenous Immunoglobulin for Guillain-Barre Syndrome","status":"NOT_YET_RECRUITING","sponsor":"The First Affiliated Hospital of Zhengzhou University","startDate":"2026-01-01","conditions":"Guillain-Barre Syndrome","enrollment":204},{"nctId":"NCT06373211","phase":"PHASE2","title":"Early Immunotherapy with Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients with Anti-Hu-associated Paraneoplastic Sensory Neuronopathy","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2025-01-10","conditions":"Paraneoplastic Sensory Neuronopathy","enrollment":21},{"nctId":"NCT06183645","phase":"","title":"Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility.","status":"RECRUITING","sponsor":"Centre Hospitalier Universitaire de Liege","startDate":"2023-08-28","conditions":"Chronic Inflammatory Demyelinating Polyneuropathy","enrollment":40},{"nctId":"NCT06686927","phase":"PHASE2","title":"Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP","status":"RECRUITING","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","startDate":"2024-11-20","conditions":"Primary Immune Thrombocytopenia","enrollment":36},{"nctId":"NCT04842643","phase":"PHASE3","title":"An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease","status":"COMPLETED","sponsor":"Takeda","startDate":"2021-04-27","conditions":"Primary Immunodeficiency Disease","enrollment":12},{"nctId":"NCT03289403","phase":"PHASE2","title":"The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis","status":"COMPLETED","sponsor":"Aljazeera Hospital","startDate":"2018-03-07","conditions":"Infertility, Autoimmune Thyroiditis","enrollment":194},{"nctId":"NCT04881682","phase":"PHASE2","title":"Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","status":"RECRUITING","sponsor":"University of Ulm","startDate":"2023-05-01","conditions":"CIDP","enrollment":20},{"nctId":"NCT03092180","phase":"","title":"Optimizing Treatment on Idiopathic Inflammatory Myopathies","status":"RECRUITING","sponsor":"University of Sao Paulo","startDate":"2005-01","conditions":"Idiopathic Inflammatory Myopathies","enrollment":60},{"nctId":"NCT06697431","phase":"PHASE4","title":"Non Inferiority KawasakI Trial With Anakinra","status":"NOT_YET_RECRUITING","sponsor":"Meyer Children's Hospital IRCCS","startDate":"2025-04-01","conditions":"Kawasaki Disease, Anakinra","enrollment":38},{"nctId":"NCT06696807","phase":"","title":"Immunomodulatory Therapy & VSA","status":"COMPLETED","sponsor":"Dao Wen Wang","startDate":"2018-10-01","conditions":"Vasospastic Angina","enrollment":71}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":9510,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Gamunex Intravenous Immunoglobulin","genericName":"Gamunex Intravenous Immunoglobulin","companyName":"National Institute of Mental Health (NIMH)","companyId":"national-institute-of-mental-health-nimh","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Gamunex is an intravenous immunoglobulin (IVIG) that provides passive immunity by supplying pooled human antibodies to enhance immune function and modulate inflammatory responses. Used for Primary immunodeficiency disorders, Secondary immunodeficiency, Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}