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
Showing 1 to 10 of 19 diseases
| 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 | EUCTR2015-003652-52-GB (EUCTR) | 02/02/2017 | 08/08/2016 | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacok ... | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacok ... | Replacement therapy in patients with primary immunodeficiency disease (PID) MedDRA version: 19.0;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] Replacement therapy in patients with primary immunodeficiency disease (PID) MedDRA version: 19.0;Lev ... | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN ... | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Spain;Russian Federation;Germany;United Kingdom | ||
| 2 | NCT02810444 (ClinicalTrials.gov) | October 4, 2016 | 15/6/2016 | Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID | An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID) An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacok ... | Primary Immunodeficiency Disease | Biological: IgG Next Generation (BT595) | Biotest | Syneos Health | Completed | 2 Years | 75 Years | All | 81 | Phase 3 | United States;Germany;Hungary;Russian Federation;Spain |
| 3 | EUCTR2015-003652-52-DE (EUCTR) | 29/09/2016 | 18/05/2016 | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacok ... | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacok ... | Replacement therapy in patients with primary immunodeficiency disease (PID) MedDRA version: 20.0;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] Replacement therapy in patients with primary immunodeficiency disease (PID) MedDRA version: 20.0;Lev ... | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN ... | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;Germany;United Kingdom | ||
| 4 | EUCTR2015-003652-52-ES (EUCTR) | 19/09/2016 | 15/07/2016 | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacok ... | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacok ... | Replacement therapy in patients with primary immunodeficiency disease (PID) MedDRA version: 19.0;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] Replacement therapy in patients with primary immunodeficiency disease (PID) MedDRA version: 19.0;Lev ... | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN ... | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | 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 ... | United States;Hungary;Spain;Russian Federation;Germany;United Kingdom | ||
| 5 | 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 clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety ... | A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients w ... | 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] Primary Immunofediciency (PID) syndromes MedDRA version: 14.1;Level: HLT;Classification code 1003670 ... | 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 Product Name: Human Normal Immunoglobulinforsubcutaneous administration Product Code: LFB-IgSC INN or ... | 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 | ||
| 6 | 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 clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety ... | A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients w ... | 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] Primary Immunofediciency (PID) syndromes MedDRA version: 14.1;Level: HLT;Classification code 1003670 ... | 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 Product Name: Human Normal Immunoglobulinforsubcutaneous administration Product Code: LFB-IgSC INN or ... | LFB Biotechnologies | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | France;Hungary;Poland;Ukraine;Germany;Italy;United Kingdom | ||
| 7 | 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 clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety ... | A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients w ... | 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] Primary Immunofediciency (PID) syndromes MedDRA version: 16.0;Level: HLT;Classification code 1003670 ... | 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 Product Name: Human Normal Immunoglobulinforsubcutaneous administration Product Code: LFB-IgSC INN or ... | LFB Biotechnologies | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | France;Hungary;Poland;Ukraine;Germany;Italy;United Kingdom | ||
| 8 | 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 clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety ... | A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes - NA A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients w ... | 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] Primary Immunofediciency (PID) syndromes MedDRA version: 14.1;Level: HLT;Classification code 1003670 ... | 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 Product Name: Human Normal Immunoglobulinforsubcutaneous administration Product Code: LFB-IgSC INN or ... | LFB Biotechnologies | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | France;Hungary;Poland;Ukraine;Germany;United Kingdom;Italy | ||
| 9 | EUCTR2010-023483-41-FR (EUCTR) | 24/04/2013 | 04/01/2011 | A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID) A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IM ... | A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID) A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IM ... | a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked agammaglobulinemia (XLA)• Autosomal recessive inherited agammaglobulinemia (including autosomal recessive hyper-IgM syndrome)• Common variable immunodeficiency (CVID)• IgG subclass deficiency (at least 2 subclasses) with clinical manifestations of immunodeficiency MedDRA version: 12.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked ag ... | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE Product Name: HUMAN NORMAL IMMUNOGLOBULINFOR Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMU ... | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;Hungary | ||
| 10 | EUCTR2010-023483-41-HU (EUCTR) | 01/03/2011 | 10/11/2010 | A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of the product in patients suffering from deficiency in their immune system A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of ... | A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID) - I10E-0718 A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IM ... | a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked agammaglobulinemia (XLA)• Common variable immunodeficiency (CVID) MedDRA version: 14.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 100000004870 MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;Classification code 10001471;Term: Agammaglobulinemia;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked ag ... | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE Product Name: HUMAN NORMAL IMMUNOGLOBULINFOR Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMU ... | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 60 | Serbia;France;Czech Republic;Hungary;Poland;Ukraine;Lithuania |