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
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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 |
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1 | NCT03033745 (ClinicalTrials.gov) | February 1, 2017 | 23/1/2017 | Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID) Safety and Tolerability of Higher Infusion Parameters of IgPro20(Hizentra) in Subjects With Primary ... | An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in Subjects With Primary Immunodeficiency An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameter ... | Primary Immunodeficiency | Drug: IgPro20 | CSL Behring | NULL | Completed | 2 Years | N/A | All | 49 | Phase 4 | United States;Canada |
2 | NCT01461018 (ClinicalTrials.gov) | October 2011 | 24/10/2011 | Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study) Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20in Subjects ... | A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) Ig ... | Primary Immune Deficiency | Biological: Immune globulin subcutaneous (Human) | CSL Behring | NULL | Completed | N/A | 75 Years | Both | 22 | Phase 3 | Japan |
3 | NCT01458171 (ClinicalTrials.gov) | April 2011 | 12/10/2011 | Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan ... | A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Sub ... | Primary Immune Deficiency Disorder | Biological: Immune globulin subcutaneous (Human) | CSL Behring | NULL | Completed | N/A | 75 Years | All | 23 | Phase 3 | Japan |
4 | NCT01199705 (ClinicalTrials.gov) | September 2010 | 8/9/2010 | Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) | A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcu ... | Primary Immune Deficiency | Biological: Immune Globulin Subcutaneous (Human) (SCIG) | CSL Behring | NULL | Completed | N/A | 75 Years | All | 25 | Phase 3 | Japan |
5 | EUCTR2008-000830-30-SE (EUCTR) | 17/12/2008 | 03/11/2008 | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutane ... | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutane ... | PID (primary immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome PID (primary immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Pri ... | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: normal human immunoglobulin G | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Sweden | |||
6 | EUCTR2008-000830-30-GB (EUCTR) | 10/12/2008 | 20/01/2009 | Extension study designed to test the long-term safety and effectiveness of Immunoglobulin Subcutaneous (Human), IgPro20. Extension study designed to test the long-term safety and effectiveness of Immunoglobulin Subcutaneo ... | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency (IgPro20 EU Extension Study) A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutane ... | PID (Primary Immune Deficiency) MedDRA version: 13.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] PID (Primary Immune Deficiency) MedDRA version: 13.1;Level: PT;Classification code 10064859;Term: Pr ... | Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | France;Spain;Poland;Romania;Germany;Switzerland;United Kingdom;Sweden | ||
7 | EUCTR2008-000830-30-FR (EUCTR) | 24/11/2008 | 21/10/2008 | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutane ... | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutane ... | PID (primary immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome PID (primary immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Pri ... | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 3 | France;Spain;Germany;United Kingdom;Sweden | ||
8 | EUCTR2008-000830-30-ES (EUCTR) | 12/11/2008 | 01/10/2008 | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of ImmuneGlobulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study)Un estudio de extensión multicéntrico sobre la eficacia, tolerabilidad y seguridad de la inmunoglobulina subcutánea (humana) IgPro20 en pacientes con inmunodeficiencia primaria(Estudio de extensión de la UE sobre IgPro20) A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of ImmuneGlobulin Subcutaneo ... | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of ImmuneGlobulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study)Un estudio de extensión multicéntrico sobre la eficacia, tolerabilidad y seguridad de la inmunoglobulina subcutánea (humana) IgPro20 en pacientes con inmunodeficiencia primaria(Estudio de extensión de la UE sobre IgPro20) A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of ImmuneGlobulin Subcutaneo ... | Primary Immunodeficiency (PID)inmunodeficiencia primaria (IDP) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome Primary Immunodeficiency (PID)inmunodeficiencia primaria (IDP) MedDRA version: 9.1;Level: LLT;Classi ... | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Sweden | |||
9 | EUCTR2006-006745-13-PL (EUCTR) | 16/10/2008 | 11/08/2008 | A multicenter study of the efficacy, tolerability, safety, and pharmacokinetics of Immune Globuline Subcutaneous (Human) IgPro20 in subjects with Primary Immunodeficiency (PID) A multicenter study of the efficacy, tolerability, safety, and pharmacokinetics of Immune Globuline ... | A multicenter study of the efficacy, tolerability, safety, and pharmacokinetics of Immune Globuline Subcutaneous (Human) IgPro20 in subjects with Primary Immunodeficiency (PID) A multicenter study of the efficacy, tolerability, safety, and pharmacokinetics of Immune Globuline ... | PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Pri ... | Product Name: IgPro20 Other descriptive name: IMMUNOGLOBULIN G | CSL Behring | NULL | Not Recruiting | Female: yes Male: yes | 43 | Phase 3 | France;Spain;Poland;Germany;Italy;United Kingdom;Sweden | ||
10 | NCT00751621 (ClinicalTrials.gov) | August 2008 | 11/9/2008 | Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study) Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension St ... | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (IgPro20 EU Extension Study) A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutane ... | Primary Immunodeficiency (PID) | Biological: IgPro20 | CSL Behring | NULL | Completed | 2 Years | 65 Years | All | 40 | Phase 3 | France;Germany;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom |