Immune Globulin Intravenous (Human) ( 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11

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
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PhaseCountries
1NCT02269163
(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
2NCT01218438
(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
3NCT01406470
(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
4NCT01412385
(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
5NCT00814320
(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
6NCT00634569
(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
7NCT00546871
(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
8NCT00389324
(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
9NCT00220766
(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
10NCT00157079
(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/AAll61Phase 3United States
11NCT00161993
(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/AAll24Phase 2Finland;Sweden