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 | 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 I10E in patients with primary Immune ThrombocytoPenia (ITP) | 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] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | France;Belarus;Hungary;Poland;Spain;Ukraine;Russian Federation;Germany;Italy | ||
| 2 | EUCTR2011-001354-29-HU (EUCTR) | 09/11/2011 | 12/10/2011 | 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 I10E in patients with primary Immune ThrombocytoPenia (ITP) | 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: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy | |||
| 3 | EUCTR2011-001354-29-DE (EUCTR) | 12/10/2011 | 06/10/2011 | 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 I10E in patients with primary Immune ThrombocytoPenia (ITP) | 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: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE Other descriptive name: human Immunoglobulin | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy | |||
| 4 | EUCTR2005-003552-35-FR (EUCTR) | 10/05/2007 | 29/12/2006 | Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults - N/A | Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults - N/A | the medical condition which have to be investigated is the evolution of platelets counts in adults with a idiopathic thrombocytopenic purpura, with less than 20 10^9 platelets/L and treated by Octagam10% (immunoglobulines). | Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | Phase 3 | France;Czech Republic;Austria;Germany | ||
| 5 | 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 | |||
| 6 | 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 |