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 | EUCTR2013-000620-34-GB (EUCTR) | 10/01/2014 | 09/08/2013 | A clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety and its behaviour in human blood in patients with Primary Immunodeficiency (PID) syndromes | A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes | Primary Immunofediciency (PID) syndromes MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Human Normal Immunoglobulin for subcutaneous administration Product Code: LFB-IgSC INN or Proposed INN: Human Normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | LFB Biotechnologies | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | France;Hungary;Poland;Ukraine;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2013-000620-34-DE (EUCTR) | 07/10/2013 | 05/08/2013 | A clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety and its behaviour in human blood in patients with Primary Immunodeficiency (PID) syndromes | A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes | Primary Immunofediciency (PID) syndromes MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Human Normal Immunoglobulin for subcutaneous administration Product Code: LFB-IgSC INN or Proposed INN: Human Normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | LFB Biotechnologies | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | France;Hungary;Poland;Ukraine;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2013-000620-34-HU (EUCTR) | 19/09/2013 | 01/08/2013 | A clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety and its behaviour in human blood in patients with Primary Immunodeficiency (PID) syndromes | A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes | Primary Immunofediciency (PID) syndromes MedDRA version: 16.0;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Human Normal Immunoglobulin for subcutaneous administration Product Code: LFB-IgSC INN or Proposed INN: Human Normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | LFB Biotechnologies | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | France;Hungary;Poland;Ukraine;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2013-000620-34-IT (EUCTR) | 05/08/2013 | 30/07/2013 | A clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety and its behaviour in human blood in patients with Primary Immunodeficiency (PID) syndromes | A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes - NA | Primary Immunofediciency (PID) syndromes MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Human Normal Immunoglobulin for subcutaneous administration Product Code: LFB-IgSC INN or Proposed INN: Human Normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | LFB Biotechnologies | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | France;Hungary;Poland;Ukraine;Germany;United Kingdom;Italy | ||
| 5 | NCT00542997 (ClinicalTrials.gov) | September 2007 | 11/10/2007 | Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy | A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency | Common Variable Immunodeficiency;X-linked Agammaglobulinemia;Autosomal Recessive Agammaglobulinemia | Biological: Human Normal Immunoglobulin for Subcutaneous Administration (IGSC) | CSL Behring | NULL | Completed | 2 Years | 65 Years | All | 51 | Phase 3 | France;Germany;Italy;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom |
| 6 | NCT00419341 (ClinicalTrials.gov) | November 2006 | 22/12/2006 | Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy | A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID) | Primary Immune Deficiency | Biological: Human Normal Immunoglobulin for Subcutaneous Administration | CSL Behring | NULL | Completed | 2 Years | 75 Years | All | 49 | Phase 3 | United States |