65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details
臨床試験数 : 482 / 薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
| 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 | EUCTR2012-000792-16-DE (EUCTR) | 03/09/2012 | 10/05/2012 | Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseases | CLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES” | primary immunodeficiency disease (PID) MedDRA version: 14.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Classification code 10049485;Term: Bruton's agammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Octagam 5% Product Name: Octagam 5% Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 23 | Czech Republic;Hungary;Germany | |||
| 2 | EUCTR2012-000792-16-HU (EUCTR) | 14/06/2012 | 20/03/2012 | Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseases | CLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES” | primary immunodeficiency disease (PID) MedDRA version: 14.1;Level: LLT;Classification code 10049485;Term: Bruton's agammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: OCTAGAM 50 mg/ml oldatos infúzió Product Name: Octagam 5% Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 23 | Czech Republic;Hungary;Germany | |||
| 3 | EUCTR2012-000792-16-CZ (EUCTR) | 29/05/2012 | 27/03/2012 | Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseases | CLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES” | primary immunodeficiency disease (PID) MedDRA version: 14.1;Level: LLT;Classification code 10049485;Term: Bruton's agammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: OCTAGAM Product Name: Octagam 5% Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 23 | Hungary;Czech Republic;Germany | |||
| 4 | EUCTR2009-011434-10-DE (EUCTR) | 02/03/2010 | 27/10/2009 | CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES | CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES | Primary immunodeficiency diseases MedDRA version: 12.0;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency MedDRA version: 12.0;Classification code 10049485;Term: Bruton's agammaglobulinemia | Product Name: NewGam Product Code: NewGam INN or Proposed INN: immunoglobulin G Other descriptive name: NewGam | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Germany | |||
| 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 Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | PID (primary immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | 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 | 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 Subcutaneous (Human) IgPro20 in subjects with Primary Immunodeficiency (PID) | PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | 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 | ||
| 7 | NCT00680446 (ClinicalTrials.gov) | April 2008 | 16/5/2008 | Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency | An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID). | Primary Immune Deficiency | Drug: Immunoglobulin G (Ig NextGen 16%) | CSL Limited | NULL | Completed | 3 Years | N/A | Both | 41 | Phase 3 | Australia;New Zealand |
| 8 | EUCTR2014-003772-23-Outside-EU/EEA (EUCTR) | 14/04/2015 | Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID) | A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID) | Primary Immune Deficiency (Common Variable Immunodeficiency and X-linked agammaglobulinemia) MedDRA version: 17.1;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] | Trade Name: Privigen® Product Name: Privigen® INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring AG | NULL | NA | Female: yes Male: yes | 55 | United States | ||||
| 9 | EUCTR2011-005015-82-Outside-EU/EEA (EUCTR) | 10/01/2012 | Study to evaluate the safety of human immune globulin in patients withprimary immunodeficiency diseases. | Clinical study to evaluate the safety and tolerability of immunoglobulin intravenous (human) 10% (NewGam) administered at high infusion rates to patients with primary immunodeficiency diseases (extension of study NGAM 01) | primary immunodeficiency diseases MedDRA version: 14.1;Level: LLT;Classification code 10049485;Term: Bruton's agammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NewGAM Product Code: NewGam Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | NA | Female: yes Male: yes | 20 | United States | ||||
| 10 | EUCTR2009-011434-10-Outside-EU/EEA (EUCTR) | 27/01/2012 | Study to evaluate the efficacy, metabolism and safety of human immune globulin in patients with primary immunodeficiency diseases. | CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES | Primary immunodeficiency diseases MedDRA version: 14.1;Level: LLT;Classification code 10049485;Term: Bruton's agammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NewGam Product Code: NewGam Other descriptive name: Immunoglobulin G | OCTAPHARMA AG | NULL | NA | Female: yes Male: yes | 51 | United States |