63. 特発性血小板減少性紫斑病 Idiopathic thrombocytopenic purpura Clinical trials / Disease details
臨床試験数 : 391 / 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
| 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 | EUCTR2015-003653-17-CZ (EUCTR) | 07/05/2018 | 09/09/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 20.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: Human Normal Immunoglobulin (iv) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest 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 | Hungary;Czech Republic;Spain;Bulgaria;Germany | ||
| 2 | EUCTR2015-003653-17-BG (EUCTR) | 27/01/2017 | 21/11/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 20.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: Human Normal Immunoglobulin (iv) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest 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 | Czech Republic;Hungary;Spain;Bulgaria;Germany | ||
| 3 | EUCTR2015-003653-17-DE (EUCTR) | 27/01/2017 | 17/06/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: Human Normal Immunoglobulin (iv) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest 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 | Czech Republic;Hungary;Spain;Bulgaria;Germany | ||
| 4 | NCT02859909 (ClinicalTrials.gov) | November 2016 | 25/7/2016 | This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP) | An Open Label, Prospective, Randomized, Multicenter Study Investigating Clinical Efficacy and Safety of the Human Normal Immunoglobulin for Intravenous Administration BT595 in Patients With Chronic Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia | Biological: BT595 | Biotest | Syneos Health | Completed | 18 Years | 75 Years | All | 34 | Phase 3 | Bulgaria;Czechia;Germany;Hungary;Serbia;Spain |
| 5 | EUCTR2015-003653-17-HU (EUCTR) | 07/09/2016 | 19/07/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: Human Normal Immunoglobulin (iv) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest 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 | Czech Republic;Hungary;Spain;Bulgaria;Germany | ||
| 6 | EUCTR2015-003653-17-ES (EUCTR) | 06/09/2016 | 11/08/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: Human Normal Immunoglobulin (iv) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest 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 | Czech Republic;Hungary;Spain;Bulgaria;Germany |