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
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 | EUCTR2015-003653-17-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 ... | 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 ... | 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] Chronic primary immune thrombocytopenia (ITP) MedDRA version: 20.0;Level: LLT;Classification code 10 ... | 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 | 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 ... | Hungary;Czech Republic;Spain;Bulgaria;Germany | ||
| 2 | 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 ... | 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 ... | 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] Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10 ... | 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 | 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 ... | Czech Republic;Hungary;Spain;Bulgaria;Germany | ||
| 3 | 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 ... | 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 ... | 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] Chronic primary immune thrombocytopenia (ITP) MedDRA version: 20.0;Level: LLT;Classification code 10 ... | 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 | 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 ... | 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) This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopen ... | 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 ... | 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 ... | 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 ... | 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] Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10 ... | 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 | 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 ... | 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 ... | 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 ... | 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] Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10 ... | 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 | 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 ... | Czech Republic;Hungary;Spain;Bulgaria;Germany | ||
| 7 | EUCTR2011-001354-29-ES (EUCTR) | 24/09/2012 | 19/07/2012 | An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP) An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) i ... | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune Thrombo ... | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminolog ... | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE Product Name: HUMAN NORMAL IMMUNOGLOBULINFOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HU ... | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | France;Belarus;Hungary;Poland;Spain;Ukraine;Russian Federation;Germany;Italy | ||
| 8 | EUCTR2012-000796-16-PL (EUCTR) | 17/08/2012 | 25/06/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune th ... | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFIC ... | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;T ... | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Othe ... | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria | ||
| 9 | EUCTR2012-000796-16-BG (EUCTR) | 18/07/2012 | 22/05/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune th ... | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFIC ... | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;T ... | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Othe ... | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria | ||
| 10 | EUCTR2012-000796-16-DE (EUCTR) | 09/07/2012 | 20/03/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune th ... | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFIC ... | Primary Immune Thrombocytopenia (ITP) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Primary Immune Thrombocytopenia (ITP) MedDRA version: 14.1;Level: LLT;Classification code 10023095;T ... | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Othe ... | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Germany;Czech Republic;Poland;Bulgaria |