65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details
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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04346108 (ClinicalTrials.gov) | August 11, 2020 | 10/4/2020 | A Study 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 Shire | NULL | Completed | 2 Years | N/A | All | 17 | Phase 3 | Japan |
| 2 | NCT02269163 (ClinicalTrials.gov) | January 26, 2016 | 16/10/2014 | Study 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 Diseases | Primary Immunodeficiency | Biological: Immune Globulin Intravenous;Biological: Prometic's Immune Globulin Intravenous 10% | Prometic Biotherapeutics, Inc. | Atlantic Research Group | Completed | 2 Years | 80 Years | All | 82 | Phase 3 | United States |
| 3 | NCT01218438 (ClinicalTrials.gov) | January 2013 | 8/10/2010 | Phase 2/3 Study of IGSC, 20% in PIDD | A 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% Solution | Baxalta now part of Shire | NULL | Completed | 2 Years | N/A | All | 86 | Phase 2/Phase 3 | United States;Canada |
| 4 | NCT01406470 (ClinicalTrials.gov) | September 2011 | 26/7/2011 | Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency | An 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 Immunodeficiency | Immunologic Deficiency Syndrome | Drug: Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™ | Green Cross Corporation | Atlantic Research Group | Completed | 2 Years | 70 Years | Both | 45 | Phase 3 | United States;Canada |
| 5 | NCT01412385 (ClinicalTrials.gov) | June 20, 2011 | 8/8/2011 | Immune 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 Diseases | Primary 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 Shire | NULL | Completed | 2 Years | N/A | All | 55 | Phase 2/Phase 3 | Austria;Germany;Hungary;Sweden;United Kingdom |
| 6 | NCT00814320 (ClinicalTrials.gov) | December 18, 2008 | 23/12/2008 | Gammagard Liquid and rHuPH20 in PID | Efficacy, 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 Diseases | Primary Immunodeficiency Diseases (PID) | Biological: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV) | Baxalta now part of Shire | NULL | Completed | 2 Years | N/A | All | 89 | Phase 3 | United States;Canada |
| 7 | NCT00546871 (ClinicalTrials.gov) | October 3, 2007 | 18/10/2007 | Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects | Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human) 10% (IGIV, 10%) Administered Intravenously or Subcutaneously in Subjects With Primary Immunodeficiency Diseases | Primary Immunodeficiency Diseases (PID) | Drug: Immune Globulin Intravenous (Human), 10% | Baxalta now part of Shire | NULL | Completed | 24 Months | N/A | All | 49 | Phase 2/Phase 3 | United States |
| 8 | NCT00782106 (ClinicalTrials.gov) | December 4, 2006 | 29/10/2008 | Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously | Phase 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 intravenous | Baxalta now part of Shire | NULL | Completed | 16 Years | N/A | All | 11 | Phase 1/Phase 2 | United States |
| 9 | NCT00389324 (ClinicalTrials.gov) | November 2006 | 17/10/2006 | A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency | An 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 Immunodeficiency | Immunologic Deficiency Syndrome | Biological: Immune Globulin Intravenous (Human) | Grifols Therapeutics Inc. | NULL | Completed | 13 Years | 75 Years | All | 35 | Phase 2 | United States;Canada |
| 10 | NCT00220766 (ClinicalTrials.gov) | August 2002 | 13/9/2005 | Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients | IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients | Immunologic Deficiency Syndrome;Agammaglobulinemia;Severe Combined Immunodeficiency;Wiskott-Aldrich Syndrome;Common Variable Immunodeficiency | Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified;Drug: Dextrose, 5% in Water | Grifols Therapeutics Inc. | NULL | Completed | 18 Years | 75 Years | Both | 100 | Phase 3 | United States;Canada |
| 11 | NCT00157079 (ClinicalTrials.gov) | June 25, 2002 | 8/9/2005 | Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders | A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders | Primary Immunodeficiency Diseases (PID);Immune Thrombocytopenic Purpura (ITP);Kawasaki Syndrome | Biological: Immune Globulin Intravenous (Human), 10% | Baxalta now part of Shire | NULL | Completed | 24 Months | N/A | All | 61 | Phase 3 | United States |
| 12 | NCT00161993 (ClinicalTrials.gov) | June 13, 2002 | 8/9/2005 | Safety, 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 Agammaglobulinemia | Primary Immunodeficiency Diseases (PID);Agammaglobulinemia;Hypogammaglobulinemia | Drug: Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution;Drug: Gammagard S/D (Solvent/Detergent) | Baxalta now part of Shire | NULL | Completed | 18 Years | N/A | All | 24 | Phase 2 | Finland;Sweden |