{"id":"gammaplex-10","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":{"chemblId":"CHEMBL39541","moleculeType":"Small molecule","molecularWeight":"785.11"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As an IVIG product, Gammaplex 10 contains polyvalent human immunoglobulins (primarily IgG) derived from pooled plasma of multiple donors. It works through multiple mechanisms including antibody replacement in immunodeficiency states, immune modulation via Fc receptor engagement, and neutralization of pathogenic antibodies and antigens. The preparation is used to restore or enhance immune function in patients with deficient or dysfunctional antibody responses.","oneSentence":"Gammaplex 10 is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:13:40.215Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders"},{"name":"Secondary immunodeficiency in hematologic malignancies"},{"name":"Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy)"}]},"trialDetails":[{"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":"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":"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":"NCT04224558","phase":"PHASE1, PHASE2","title":"Stem Cell Transplantation in Crohn's Disease","status":"RECRUITING","sponsor":"Cedars-Sinai Medical Center","startDate":"2019-11-15","conditions":"Crohn Disease","enrollment":15},{"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":"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":"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":"NCT04083183","phase":"PHASE1, PHASE2","title":"Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases","status":"RECRUITING","sponsor":"Fred Hutchinson Cancer Center","startDate":"2020-06-16","conditions":"Non-Malignant Neoplasm","enrollment":40},{"nctId":"NCT05084053","phase":"PHASE3","title":"A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Takeda","startDate":"2022-01-19","conditions":"Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), Multifocal Motor Neuropathy (MMN)","enrollment":26},{"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":"NCT05513586","phase":"PHASE3","title":"A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants","status":"COMPLETED","sponsor":"Takeda","startDate":"2022-09-13","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":15},{"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":"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":"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":"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":"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":"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":"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":"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":"NCT05150340","phase":"PHASE3","title":"A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID)","status":"COMPLETED","sponsor":"Takeda","startDate":"2022-01-24","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":16},{"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":"NCT01019876","phase":"PHASE2, PHASE3","title":"Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases","status":"COMPLETED","sponsor":"Columbia University","startDate":"2002-09","conditions":"Bone Marrow Failure, Osteopetrosis, Fanconi Anemia","enrollment":38},{"nctId":"NCT05422365","phase":"PHASE3","title":"Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults","status":"COMPLETED","sponsor":"Biopharma Plasma LLC","startDate":"2022-07-26","conditions":"Primary Immune Thrombocytopenia","enrollment":32},{"nctId":"NCT02955355","phase":"PHASE3","title":"Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2016-11-14","conditions":"Chronic Inflammatory Demyelinating Polyradiculoneuropathy","enrollment":85},{"nctId":"NCT01184846","phase":"PHASE3","title":"Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2010-11","conditions":"Chronic Inflammatory Demyelinating Polyneuropathy","enrollment":31},{"nctId":"NCT06231719","phase":"NA","title":"Efficacy of Manuel Pressure and Local Cold Spray in Reducing Injection Pain in Pregnant Women","status":"ACTIVE_NOT_RECRUITING","sponsor":"Gulsum Coskun","startDate":"2023-12-01","conditions":"Pain, Acute, Alloimmunisation in Pregnancy, Injection Site","enrollment":129},{"nctId":"NCT02915263","phase":"PHASE2","title":"The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes","status":"TERMINATED","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2017-09-11","conditions":"Diabetes Complications, Diabetes Mellitus, Diabetic Neuropathies","enrollment":13},{"nctId":"NCT06223984","phase":"PHASE4","title":"Combined Use of Immunoglobulin and Pulse Steroid Therapies in Severe Covid-19 Patients","status":"COMPLETED","sponsor":"Konya City Hospital","startDate":"2020-03-30","conditions":"Pulse Steroid and Immunoglobulins Drugs in Covid 19 Patients","enrollment":178},{"nctId":"NCT04400058","phase":"PHASE3","title":"Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression","status":"COMPLETED","sponsor":"Octapharma","startDate":"2020-06-01","conditions":"Covid-19","enrollment":207},{"nctId":"NCT04381936","phase":"PHASE3","title":"Randomised Evaluation of COVID-19 Therapy","status":"RECRUITING","sponsor":"University of Oxford","startDate":"2020-03-19","conditions":"Severe Acute Respiratory Syndrome","enrollment":70000},{"nctId":"NCT04578535","phase":"PHASE1","title":"A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2020-10-27","conditions":"Healthy Volunteers","enrollment":51},{"nctId":"NCT03277313","phase":"PHASE3","title":"Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2017-09-25","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":44},{"nctId":"NCT03401073","phase":"PHASE2","title":"IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3","status":"COMPLETED","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2018-09-01","conditions":"Small Fiber Neuropathy, Idiopathic Peripheral Neuropathy","enrollment":20},{"nctId":"NCT04968899","phase":"PHASE3","title":"IgIV Plus Prednisone vs High-dose Dexamethasone for ITP","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-04-07","conditions":"Immune Thrombocytopenia (ITP)","enrollment":272},{"nctId":"NCT02810444","phase":"PHASE3","title":"Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID","status":"COMPLETED","sponsor":"Biotest","startDate":"2016-10-04","conditions":"Primary Immunodeficiency Disease","enrollment":81},{"nctId":"NCT04561115","phase":"PHASE3","title":"A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2020-09-02","conditions":"Primary Immunodeficiency","enrollment":33},{"nctId":"NCT02549170","phase":"PHASE3","title":"A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2015-12-15","conditions":"Chronic Inflammatory Demyelinating Polyradiculoneuropathy","enrollment":138},{"nctId":"NCT00033293","phase":"PHASE3","title":"Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma","status":"COMPLETED","sponsor":"Children's Oncology Group","startDate":"2004-03-15","conditions":"Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Regional Neuroblastoma","enrollment":53},{"nctId":"NCT03037359","phase":"","title":"A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products","status":"UNKNOWN","sponsor":"ADMA Biologics, Inc.","startDate":"2016-12","conditions":"Primary Immune Deficiency Disorder","enrollment":200},{"nctId":"NCT03116347","phase":"PHASE4","title":"Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2017-05-30","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":42},{"nctId":"NCT02783482","phase":"PHASE3","title":"Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency","status":"COMPLETED","sponsor":"Green Cross Corporation","startDate":"2016-10","conditions":"Immunologic Deficiency Syndromes","enrollment":49},{"nctId":"NCT05634824","phase":"PHASE2","title":"IVIg Plus Low Dose rhTPO for ITP in Pregnancy","status":"UNKNOWN","sponsor":"Peking University People's Hospital","startDate":"2023-01-01","conditions":"Immune Thrombocytopenia, Pregnancy Related","enrollment":50},{"nctId":"NCT05134792","phase":"PHASE2, PHASE3","title":"Effect of Pre-emptive Intravenous Immunoglobulin (IVIG) on the Incidence of Septic Episodes in Pediatric Burn Patients","status":"COMPLETED","sponsor":"Cairo University","startDate":"2021-10-10","conditions":"Burn Shock","enrollment":30},{"nctId":"NCT01300728","phase":"PHASE2","title":"Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment","status":"COMPLETED","sponsor":"Sutter Health","startDate":"2011-01-01","conditions":"Mild Cognitive Impairment","enrollment":52},{"nctId":"NCT02593188","phase":"","title":"Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2015-11-12","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":264},{"nctId":"NCT04834908","phase":"PHASE1, PHASE2","title":"Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection","status":"TERMINATED","sponsor":"Bharat Serums and Vaccines Limited","startDate":"2021-07-27","conditions":"SARS-CoV-2 Infection","enrollment":7},{"nctId":"NCT04480424","phase":"PHASE2","title":"Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2020-09-17","conditions":"COVID-19","enrollment":100},{"nctId":"NCT02240407","phase":"PHASE1","title":"Re-administration of Intramuscular AAV9 in Patients With Late-Onset Pompe Disease","status":"COMPLETED","sponsor":"University of Florida","startDate":"2017-10-17","conditions":"Pompe Disease","enrollment":2},{"nctId":"NCT02728752","phase":"PHASE3","title":"Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)","status":"COMPLETED","sponsor":"Octapharma","startDate":"2017-02-27","conditions":"Dermatomyositis","enrollment":95},{"nctId":"NCT03065244","phase":"PHASE3","title":"KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)","status":"COMPLETED","sponsor":"University of California, San Diego","startDate":"2017-02-17","conditions":"Mucocutaneous Lymph Node Syndrome","enrollment":105},{"nctId":"NCT02269163","phase":"PHASE3","title":"Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%","status":"COMPLETED","sponsor":"Prometic Biotherapeutics, Inc.","startDate":"2016-01-26","conditions":"Primary Immunodeficiency","enrollment":82},{"nctId":"NCT01432080","phase":"PHASE2","title":"Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant","status":"TERMINATED","sponsor":"Maisonneuve-Rosemont Hospital","startDate":"2011-09","conditions":"Respiratory Tract Infections, Bronchiolitis Obliterans, Cryptogenic Organizing Pneumonia","enrollment":12},{"nctId":"NCT00157079","phase":"PHASE3","title":"Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2002-06-25","conditions":"Primary Immunodeficiency Diseases (PID), Immune Thrombocytopenic Purpura (ITP), Kawasaki Syndrome","enrollment":61},{"nctId":"NCT00161993","phase":"PHASE2","title":"Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2002-06-13","conditions":"Primary Immunodeficiency Diseases (PID), Agammaglobulinemia, Hypogammaglobulinemia","enrollment":24},{"nctId":"NCT00538915","phase":"PHASE3","title":"Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)","status":"COMPLETED","sponsor":"ADMA Biologics, Inc.","startDate":"2007-09","conditions":"Primary Immune Deficiency Disorders (PIDD)","enrollment":63},{"nctId":"NCT01218438","phase":"PHASE2, PHASE3","title":"Phase 2/3 Study of IGSC, 20% in PIDD","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2013-01-28","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":86},{"nctId":"NCT00949065","phase":"PHASE3","title":"Intravenous Immunoglobulins in Complex-regional Pain Syndrome","status":"WITHDRAWN","sponsor":"University of Giessen","startDate":"2009-08","conditions":"Complex Regional Pain Syndrome Type 1","enrollment":""},{"nctId":"NCT02303093","phase":"","title":"Non-Interventional Study on the Tolerability and Efficacy of IVIG","status":"COMPLETED","sponsor":"Octapharma","startDate":"2011-08-01","conditions":"Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG","enrollment":344},{"nctId":"NCT01485796","phase":"PHASE2, PHASE3","title":"Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2011-12-29","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":54},{"nctId":"NCT00666263","phase":"PHASE3","title":"Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2008-08-22","conditions":"Multifocal Motor Neuropathy","enrollment":50},{"nctId":"NCT00818662","phase":"PHASE3","title":"A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2008-12-19","conditions":"Alzheimer´s Disease","enrollment":390},{"nctId":"NCT01524887","phase":"PHASE3","title":"Phase 3 IGIV, 10% in Alzheimer´s Disease","status":"TERMINATED","sponsor":"Baxalta now part of Shire","startDate":"2012-01-23","conditions":"Alzheimer´s Disease","enrollment":508},{"nctId":"NCT01175213","phase":"PHASE3","title":"Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2010-07-28","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":66},{"nctId":"NCT01736579","phase":"PHASE3","title":"Long-Term Study of IGIV, 10% in Alzheimer´s Disease","status":"TERMINATED","sponsor":"Baxalta now part of Shire","startDate":"2012-11-29","conditions":"Alzheimer´s Disease","enrollment":6},{"nctId":"NCT00546871","phase":"PHASE2, PHASE3","title":"Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2007-10-03","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":49},{"nctId":"NCT00814320","phase":"PHASE3","title":"Gammagard Liquid and rHuPH20 in PID","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2008-12-18","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":89},{"nctId":"NCT02129582","phase":"PHASE1","title":"Targeted Marrow Irradiation, Fludarabine Phosphate, and Busulfan Before Donor Progenitor Cell Transplant in Treating Patients With Hematologic Malignancies","status":"COMPLETED","sponsor":"Case Comprehensive Cancer Center","startDate":"2014-11-05","conditions":"Acute Myeloid Leukemia, Hematologic Malignancies, Acute Lymphocytic Leukemia","enrollment":14},{"nctId":"NCT01412385","phase":"PHASE2, PHASE3","title":"Immune Globulin Subcutaenous (Human), 20%","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2011-06-20","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":55},{"nctId":"NCT00782106","phase":"PHASE1, PHASE2","title":"Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2006-12-04","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":11},{"nctId":"NCT00162006","phase":"PHASE2","title":"Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2003-01-13","conditions":"Immune Thrombocytopenic Purpura (ITP)","enrollment":28},{"nctId":"NCT02556775","phase":"","title":"Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2015-12-04","conditions":"Exposure During Pregnancy","enrollment":16},{"nctId":"NCT04521309","phase":"PHASE1, PHASE2","title":"SARS-CoV-2 Antibodies Based IVIG Therapy for COVID-19 Patients","status":"COMPLETED","sponsor":"Dow University of Health Sciences","startDate":"2020-06-19","conditions":"COVID-19","enrollment":50},{"nctId":"NCT02374736","phase":"PHASE3","title":"Effect of Privigen Against Graft Loss","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2016-02-05","conditions":"Kidney Transplantation","enrollment":18},{"nctId":"NCT04138485","phase":"PHASE2","title":"Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)","status":"WITHDRAWN","sponsor":"CSL Behring","startDate":"2019-12-20","conditions":"Diffuse Cutaneous Systemic Sclerosis","enrollment":""},{"nctId":"NCT04500067","phase":"PHASE3","title":"Intravenous Immunoglobulin (IVIG, Bioven) Efficacy Assess for COVID-19 / SARS-CoV-2 Severe Pneumonia Complex Treatment","status":"COMPLETED","sponsor":"Biopharma Plasma LLC","startDate":"2020-05-07","conditions":"Covid19, Pneumonia","enrollment":76},{"nctId":"NCT03752372","phase":"","title":"Microbiome Alterations in IL10RA-deficient Patients After HSCT","status":"TERMINATED","sponsor":"Children's Hospital of Fudan University","startDate":"2017-10-01","conditions":"Inflammatory Bowel Diseases, Microbiota","enrollment":13},{"nctId":"NCT02413580","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2015-03","conditions":"Myasthenia Gravis Exacerbations","enrollment":49},{"nctId":"NCT03476083","phase":"PHASE4","title":"Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission","status":"UNKNOWN","sponsor":"New Discovery LLC","startDate":"2018-06-10","conditions":"Hepatitis B Infection, Congenital Malformation, Birth Defect","enrollment":280},{"nctId":"NCT02604810","phase":"PHASE3","title":"Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2016-01","conditions":"Primary Immunodeficiency","enrollment":53},{"nctId":"NCT01854827","phase":"PHASE1, PHASE2","title":"Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia","status":"COMPLETED","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","startDate":"2013-10","conditions":"Biliary Atresia","enrollment":30},{"nctId":"NCT03319810","phase":"PHASE2","title":"Effect of IVIG on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer Disease","status":"COMPLETED","sponsor":"Sutter Health","startDate":"2018-01-04","conditions":"Mild Cognitive Impairment","enrollment":5},{"nctId":"NCT03829826","phase":"","title":"Efficacy and Mechanism of Action of SCIg in Patients With Stiff Person Syndrome (SPS)","status":"UNKNOWN","sponsor":"Thomas Jefferson University","startDate":"2019-06","conditions":"Stiff-Person Syndrome","enrollment":22},{"nctId":"NCT00115778","phase":"PHASE2","title":"Intravenous Immunoglobulin (IVIG) in Lung Transplantation","status":"COMPLETED","sponsor":"Columbia University","startDate":"2005-06","conditions":"Hypogammaglobulinemia, Lung Transplantation","enrollment":11},{"nctId":"NCT02473952","phase":"PHASE2","title":"A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2015-08","conditions":"Myasthenia Gravis, Generalized","enrollment":62},{"nctId":"NCT02130817","phase":"PHASE4","title":"Belatacept in Kidney Transplantation of Moderately Sensitized Patients","status":"WITHDRAWN","sponsor":"University of Wisconsin, Madison","startDate":"2014-09-24","conditions":"End Stage Renal Disease, Antibody Mediated Rejection","enrollment":""},{"nctId":"NCT01178216","phase":"PHASE1, PHASE2","title":"Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation","status":"COMPLETED","sponsor":"Stanley Jordan, MD","startDate":"2013-09","conditions":"End Stage Renal Disease","enrollment":41},{"nctId":"NCT00892112","phase":"PHASE3","title":"Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy","status":"COMPLETED","sponsor":"Prothya Biosolutions","startDate":"2009-11","conditions":"Myocardial Diseases, Parvovirus B19, Human","enrollment":50},{"nctId":"NCT01785056","phase":"NA","title":"IVIG Treatment in Systemic Sclerosis","status":"UNKNOWN","sponsor":"Georgetown University","startDate":"2013-04","conditions":"Systemic Sclerosis, Diffuse Scleroderma","enrollment":14},{"nctId":"NCT01545076","phase":"PHASE3","title":"Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2012-03","conditions":"Chronic Inflammatory Demyelinating Polyneuropathy, Polyradiculoneuropathy","enrollment":208},{"nctId":"NCT02788188","phase":"PHASE1","title":"Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2016-05-28","conditions":"Middle East Respiratory Syndrome Coronavirus","enrollment":38},{"nctId":"NCT02951234","phase":"NA","title":"A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease","status":"UNKNOWN","sponsor":"Chang Gung Memorial Hospital","startDate":"2016-09","conditions":"Kawasaki Disease","enrollment":278},{"nctId":"NCT00176865","phase":"PHASE2","title":"Stem Cell Transplant for Immunologic or Histiocytic Disorders","status":"COMPLETED","sponsor":"Masonic Cancer Center, University of Minnesota","startDate":"2002-08","conditions":"Hemophagocytic Lymphohistiocytosis, X-Linked Lymphoproliferative Disorders, Chediak-Higashi Syndrome","enrollment":19}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"ALOPECIA"},{"count":1,"reaction":"ARTHRALGIA"},{"count":1,"reaction":"INFUSION RELATED REACTION"}],"_approvalHistory":[],"publicationCount":6,"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":"Gammaplex 10","genericName":"Gammaplex 10","companyName":"Bio Products Laboratory","companyId":"bio-products-laboratory","modality":"Biologic","firstApprovalDate":"","aiSummary":"Gammaplex 10 is a small molecule drug that inhibits tubulin, classified as an inhibitor. It has been studied in various clinical trials for conditions such as Chronic Hepatitis B, CIDP, MMN, Primary Immunodeficiency, and Stiff Person Syndrome, among others.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}