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Immune globulin intravenous    (DrugBank: -)

1 disease
告示番号疾患名（ページ内リンク）臨床試験数
65原発性免疫不全症候群13

65. 原発性免疫不全症候群　［臨床試験数：413，薬物数：581（DrugBank：97），標的遺伝子数：68，標的パスウェイ数：202］
Searched query = "Primary immunodeficiency", "X-SCID", "Reticular dysgenesis", "Adenosine deaminase deficiency", "Omenn syndrome", "Purine nucleoside phosphorylase deficiency", "CD8 deficiency", "ZAP-70 deficiency", "MHC class I deficiency", "MHC class II deficiency", "Combined immunodeficiency", "Wiskott-Aldrich syndrome", "Telangiectasia ataxia", "Nijmegen breakage syndrome", "Bloom syndrome", "Immunodeficiency, centromere region instability, facial anomalies syndrome", "ICF syndrome", "PMS2 deficiency", "Radiosensitivity, immunodeficiency, dysmorphic features, and learning difficulties syndrome", "RIDDLE syndrome", "Schimke syndrome", "Netherton syndrome", "Thymic hypoplasia", "DiGeorge syndrome", "22q11.2 deletion syndrome", "Hyper-IgE syndrome", "Hepatic venoocclusive immunodeficiency", "Immunodeficiency with central hepatic vein atresia", "Dyskeratosis congenita", "X-linked agammaglobulinaemia", "Common variable immunodeficiency", "Hyper-IgM syndrome", "Isolated IgG subclass deficiency", "Selective IgA deficiency", "Specific antibody production deficiency", "Infant transient hypogammaglobulinemia", "Chédiak-Higashi syndrome", "Chediak-Higashi syndrome", "X-linked lymphoproliferative syndrome", "SAP deficiency", "SH2D1A/SLAM-associated protein deficiency", "XIAP deficiency", "X-linked inhibitor of apoptosis deficiency", "Autoimmune lymphoproliferative syndrome", "ALPS", "Familial hemophagocytic syndrome", "Perforin deficiency", "Munc13-4 deficiency", "Syntaxin 11 deficiency", "Munc18-2 deficiency", "Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy", "APECED", "Immune dysregulation, polyendocrinopathy, enteropathy, X-linked syndrome", "IPEX syndrome", "CD25 deficiency", "ITCH deficiency", "Primary phagocytic dysfunction", "Severe congenital neutropenia", "Cyclic neutropenia", "Hermanskyi-Pudlak syndrome type 2", "Hermanskyi-Pudlak syndrome 2", "Griscelli syndrome type 2", "Griscelli syndrome 2", "p14 deficiency", "Warts, hypogammaglobulinemia, infections, myelokathexis syndrome", "WHIM syndrome", "Glycogen storage disease type Ib", "Leukocyte adhesion deficiency", "Shwachman-Diamond syndrome", "Chronic granulomatous disease", "Myeloperoxidase deficiency", "Mendelian susceptibility to mycobacterial disease", "MSMD", "Anhidrotic ectodermal dysplasia with immunodeficiency", "EDA-ID", "Interleukin-1 receptor-associated kinase-4 deficiency", "IRAK4 deficiency", "IMyD88 deficiency", "Chronic mucocutaneous candidiasis", "Epidermodysplasia verruciformis", "Herpes simplex encephalitis", "Caspase recruitment domain family member 9 deficiency", "CARD9 deficiency", "Trypanosomiasis", "Congenital complement deficiency", "C1q deficiency", "CC1r deficiency", "CC1s deficiency", "CC2 deficiency", "CC3 deficiency", "CC4 deficiency", "CC5 deficiency", "CC6 deficiency", "CC7 deficiency", "CC8 deficiency", "CC9 deficiency", "Factor D deficiency", "Properdin deficiency", "Factor I deficiency", "Factor H deficiency", "MASP1 deficiency", "3MC syndrome", "Mannose-binding protein-associated serine protease 2 deficiency", "MASP2 deficiency", "FCN3", "Hereditary angioedema type 1", "Hereditary angioedema type I", "C1 inhibitor deficiency type 1", "C1 inhibitor deficiency type I", "Hereditary angioedema type 2", "Hereditary angioedema type II", "C1 inhibitor deficiency type 2", "C1 inhibitor deficiency type II", "Hereditary angioedema type 3", "Hereditary angioedema type III", "C1 inhibitor deficiency type 3", "C1 inhibitor deficiency type III"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
13 / 413 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT04346108
(ClinicalTrials.gov)		August 11, 202010/4/2020Pharmacokinetics, Safety and Tolerability, and Efficacy Evaluation of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)A Phase 3, Open-label, Non-controlled, Multi-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Subjects With Primary Immunodeficiency Diseases (PID)Primary Immunodeficiency Diseases (PID)Biological: Immune Globulin Intravenous (IGIV);Biological: Immune Globulin Subcutaneous, 20% Solution (IGSC, 20%)Baxalta now part of ShireNULLRecruiting2 YearsN/AAll16Phase 3Japan
2NCT02269163
(ClinicalTrials.gov)		January 26, 201616/10/2014Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%A Phase 3, Multicenter, Open-Label Study of the Safety, Tolerability, Efficacy, and PK of ProMetic BioTherapeutics IGIV (Human) 10% in Adults and Children With Primary Immunodeficiency DiseasesPrimary ImmunodeficiencyBiological: Immune Globulin Intravenous;Biological: Prometic's Immune Globulin Intravenous 10%Prometic Biotherapeutics, Inc.Atlantic Research GroupCompleted2 Years80 YearsAll82Phase 3United States
3NCT01218438
(ClinicalTrials.gov)		January 20138/10/2010Phase 2/3 Study of IGSC, 20% in PIDDA Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)Primary Immunodeficiency Diseases (PID)Biological: Immune Globulin Intravenous (Human), 10% Solution;Drug: Immune Globulin Subcutaneous (Human), 20% SolutionBaxalta now part of ShireNULLCompleted2 YearsN/AAll86Phase 2;Phase 3United States;Canada
4NCT01406470
(ClinicalTrials.gov)		September 201126/7/2011Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary ImmunodeficiencyAn Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in Subjects With Primary ImmunodeficiencyImmunologic Deficiency SyndromeDrug: Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™Green Cross CorporationAtlantic Research GroupCompleted2 Years70 YearsBoth45Phase 3United States;Canada
5NCT01412385
(ClinicalTrials.gov)		June 20, 20118/8/2011Immune Globulin Subcutaenous (Human), 20%A Clinical Study of Immune Globulin Subcutaneous (Human) (IGSC), 20% for the Evaluation of Efficacy, Safety, and Pharmacokinetics in Subjects With Primary Immunodeficiency DiseasesPrimary Immunodeficiency Diseases (PID)Biological: Immune Globulin Subcutaneous (Human), 20%;Biological: Immune Globulin Intravenous (Human), 10%;Biological: Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin)Baxalta now part of ShireNULLCompleted2 YearsN/AAll55Phase 2;Phase 3Austria;Germany;Hungary;Sweden;United Kingdom
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6NCT00814320
(ClinicalTrials.gov)		December 18, 200823/12/2008Gammagard Liquid and rHuPH20 in PIDEfficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency DiseasesPrimary Immunodeficiency Diseases (PID)Biological: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)Baxalta now part of ShireNULLCompleted2 YearsN/AAll89Phase 3United States;Canada
7NCT00634569
(ClinicalTrials.gov)		May 20085/3/2008Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric SubjectsEvaluation of the Efficacy and Safety of Flebogamma 5% DIF [Immune Globulin Intravenous (Human)] for Replacement Therapy in Pediatric Subjects With Primary Immunodeficiency Diseases.Primary Immune Deficiency DiseaseBiological: Flebogamma 5% DIFInstituto Grifols, S.A.NULLCompleted2 Years16 YearsAll24Phase 4United States
8NCT00546871
(ClinicalTrials.gov)		October 3, 200718/10/2007Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) SubjectsTolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human) 10% (IGIV, 10%) Administered Intravenously or Subcutaneously in Subjects With Primary Immunodeficiency DiseasesPrimary Immunodeficiency Diseases (PID)Drug: Immune Globulin Intravenous (Human), 10%Baxalta now part of ShireNULLCompleted24 MonthsN/AAll49Phase 2;Phase 3United States
9NCT00782106
(ClinicalTrials.gov)		December 4, 200629/10/2008Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV SubcutaneouslyPhase 1/2 Determination of the Dose of Recominant Human Hyaluronidase (rHuPH20) Required Enabling Up to 600 mg/kg Bodyweight of IGIV, 10% to be Administered Subcutaneously in a Single Infusion Site in Subjects With Primary Immunodeficiency (PID)Primary Immunodeficiency Diseases (PID)Biological: Recombinant human hyaluronidase + immune globulin intravenousBaxalta now part of ShireNULLCompleted16 YearsN/AAll11Phase 1;Phase 2United States
10NCT00389324
(ClinicalTrials.gov)		November 200617/10/2006A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary ImmunodeficiencyAn Open-Label Single-Sequence, Crossover Trial to Evaluate the Pharmacokinetics and Safety of Subcutaneous Gamunex® 10% (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) in Subjects With Primary ImmunodeficiencyImmunologic Deficiency SyndromeBiological: Immune Globulin Intravenous (Human)Grifols Therapeutics Inc.NULLCompleted13 Years75 YearsAll35Phase 2United States;Canada
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
11NCT00220766
(ClinicalTrials.gov)		August 200213/9/2005Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency PatientsIGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient PatientsImmunologic Deficiency Syndrome;Agammaglobulinemia;Severe Combined Immunodeficiency;Wiskott-Aldrich Syndrome;Common Variable ImmunodeficiencyDrug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified;Drug: Dextrose, 5% in WaterGrifols Therapeutics Inc.NULLCompleted18 Years75 YearsBoth100Phase 3United States;Canada
12NCT00157079
(ClinicalTrials.gov)		June 25, 20028/9/2005Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency DisordersA Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency DisordersPrimary Immunodeficiency Diseases (PID);Immune Thrombocytopenic Purpura (ITP);Kawasaki SyndromeBiological: Immune Globulin Intravenous (Human), 10%Baxalta now part of ShireNULLCompleted24 MonthsN/AAllPhase 3United States
13NCT00161993
(ClinicalTrials.gov)		June 13, 20028/9/2005Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or AgammaglobulinemiaPrimary Immunodeficiency Diseases (PID);Agammaglobulinemia;HypogammaglobulinemiaDrug: Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution;Drug: Gammagard S/D (Solvent/Detergent)Baxalta now part of ShireNULLCompleted18 YearsN/AAllPhase 2Finland;Sweden

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