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 | EUCTR2009-014589-24-FR (EUCTR) | 12/06/2013 | 27/09/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 14.0;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] | Product Name: NewGAM Product Code: NewGAM Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;India | ||
| 2 | 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 | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | 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] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria | ||
| 3 | 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 | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | 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] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria | ||
| 4 | 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 | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | 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] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Germany;Czech Republic;Poland;Bulgaria | ||
| 5 | EUCTR2012-000796-16-CZ (EUCTR) | 29/05/2012 | 04/04/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | 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] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria;Germany | ||
| 6 | EUCTR2009-014589-24-BG (EUCTR) | 04/01/2012 | 13/09/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 16.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: Immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;India | ||
| 7 | EUCTR2011-000263-27-BG (EUCTR) | 14/11/2011 | 25/08/2011 | An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells). | An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP | Chronic immune thrombocytopenic purpura (ITP) MedDRA version: 16.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Serbia;Poland;Turkey;Bulgaria | |||
| 8 | EUCTR2009-014589-24-DE (EUCTR) | 22/09/2011 | 12/04/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.0;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] | Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: Immunglobulin Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India | ||
| 9 | EUCTR2009-014589-24-CZ (EUCTR) | 02/09/2011 | 26/04/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.0;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] | Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India | ||
| 10 | EUCTR2011-000263-27-PL (EUCTR) | 22/07/2011 | 08/06/2011 | An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells). | An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP | Chronic immune thrombocytopenic purpura (ITP) MedDRA version: 15.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | 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 LLC | NULL | Not Recruiting | Female: yes Male: yes | 150 | Serbia;Poland;Turkey;Bulgaria | |||
| 11 | EUCTR2005-003552-35-DE (EUCTR) | 28/03/2006 | 13/01/2006 | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA version: 7.0;Level: LLT;Classification code 10021245 | Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | Czech Republic;Germany;France | |||
| 12 | EUCTR2005-003552-35-AT (EUCTR) | 20/02/2006 | 16/01/2006 | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA version: 7.0;Level: LLT;Classification code 10021245 | Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | France;Czech Republic;Austria;Germany |