AMG 531 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 63 | 特発性血小板減少性紫斑病 | 41 |
63. 特発性血小板減少性紫斑病
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 | EUCTR2010-019987-35-FR (EUCTR) | 26/06/2013 | 09/09/2010 | A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITPRemission Rates in Adult Subjects with Immune Thrombocytopenia Purpura ReceivingRomiplostim | A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITPRemission Rates in Adult Subjects with Immune Thrombocytopenia Purpura ReceivingRomiplostim | Adult immune thrombocytopenic purpura (ITP) MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: romiplostim Product Code: AMG 531 INN or Proposed INN: romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | France;Czech Republic;Spain;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2010-019987-35-CZ (EUCTR) | 21/12/2010 | 26/11/2010 | Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim | A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim | Adult 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: Nplate Product Name: romiplostim Product Code: AMG 531 INN or Proposed INN: romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2010-019987-35-GB (EUCTR) | 29/10/2010 | 26/08/2010 | Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim | A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim | Adult immune thrombocytopenic purpura (ITP) MedDRA version: 14.1;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: Nplate Product Name: romiplostim Product Code: AMG 531 INN or Proposed INN: romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2010-019987-35-DE (EUCTR) | 21/10/2010 | 25/08/2010 | Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim | A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim | Adult immune thrombocytopenic purpura (ITP) MedDRA version: 14.1;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: Nplate Product Name: romiplostim Product Code: AMG 531 INN or Proposed INN: romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2008-004347-10-BG (EUCTR) | 14/10/2010 | 12/05/2010 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 6 | EUCTR2008-004347-10-SI (EUCTR) | 12/11/2009 | 06/10/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 7 | EUCTR2008-004347-10-SE (EUCTR) | 09/09/2009 | 24/06/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 8 | EUCTR2008-004347-10-ES (EUCTR) | 16/07/2009 | 05/06/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP).-----------------------------------------------------?Estudio prospectivo, fase IV, multicéntrico y abierto para evaluar los cambios en la morfología de la médula ósea en sujetos adultos que reciben romiplostim para el tratamiento de la trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)? | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP).-----------------------------------------------------?Estudio prospectivo, fase IV, multicéntrico y abierto para evaluar los cambios en la morfología de la médula ósea en sujetos adultos que reciben romiplostim para el tratamiento de la trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)? | Thrombocytopenia associated with ITP.---------------------------trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI) MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 9 | EUCTR2008-004347-10-BE (EUCTR) | 10/07/2009 | 29/05/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Sweden | ||
| 10 | EUCTR2008-004347-10-AT (EUCTR) | 17/06/2009 | 06/05/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 11 | EUCTR2007-000638-37-IE (EUCTR) | 06/01/2009 | 10/04/2008 | An Open Label Study of AMG 531 in Severely Refractory Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of AMG 531 in Severely Refractory Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 12 | EUCTR2007-000638-37-SK (EUCTR) | 17/12/2008 | 27/10/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | Czech Republic;Slovakia;Spain;Belgium;Ireland;Austria;Netherlands;Italy;United Kingdom | ||
| 13 | EUCTR2007-000638-37-ES (EUCTR) | 17/12/2008 | 17/10/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP).-------------------------------------------------------?Estudio Abierto de Romiplostim en Sujetos Adultos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI)? | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP).-------------------------------------------------------?Estudio Abierto de Romiplostim en Sujetos Adultos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI)? | Immune (Idiopathic) Thrombocytopenic Purpura.-------------------------------------------Púrpura Trombocitopénica Inmune (Idiopática) MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Czech Republic;Netherlands;Belgium;Ireland;Spain;Italy;Austria | |||
| 14 | EUCTR2004-000172-13-GB (EUCTR) | 20/08/2008 | 11/02/2005 | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Code: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 15 | EUCTR2007-000638-37-GB (EUCTR) | 18/08/2008 | 11/04/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Czech Republic;United Kingdom;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 16 | EUCTR2004-000172-13-IT (EUCTR) | 22/07/2008 | 10/07/2008 | AN OPEN LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF LONG-TERM DOSING OF AMG 531 IN THROMBOCYTOPENIC SUBJECTS WITH IMMUNE (IDIOPATHIC) THROMBOCITOPENIC PURPURA | AN OPEN LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF LONG-TERM DOSING OF AMG 531 IN THROMBOCYTOPENIC SUBJECTS WITH IMMUNE (IDIOPATHIC) THROMBOCITOPENIC PURPURA | Thrombocytopenia in subjects with ITP MedDRA version: 14.1;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] | Product Name: AMG531 Product Code: AMG531 INN or Proposed INN: AMG531 | AMGEN S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Czech Republic;Belgium;Austria;Germany;United Kingdom;Italy | |||
| 17 | EUCTR2004-000172-13-CZ (EUCTR) | 11/06/2008 | 11/04/2008 | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Code: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;United Kingdom;Czech Republic;Belgium;Italy;Austria | |||
| 18 | EUCTR2007-000638-37-IT (EUCTR) | 09/06/2008 | 04/08/2008 | An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209 | An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209 | Thrombocytopenia in subjects with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG531 Product Code: AMG531 | AMGEN S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 19 | EUCTR2004-000172-13-AT (EUCTR) | 13/05/2008 | 10/03/2008 | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Code: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Czech Republic;Germany;United Kingdom;Belgium;Italy;Austria | |||
| 20 | EUCTR2004-000172-13-DE (EUCTR) | 07/05/2008 | 07/02/2008 | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Code: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Czech Republic;United Kingdom;Germany;Belgium;Italy;Austria | |||
| 21 | EUCTR2007-000638-37-AT (EUCTR) | 30/04/2008 | 04/03/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 22 | EUCTR2007-000638-37-CZ (EUCTR) | 09/04/2008 | 11/02/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 23 | EUCTR2004-000172-13-BE (EUCTR) | 08/04/2008 | 27/02/2008 | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Code: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Czech Republic;Germany;United Kingdom;Belgium;Italy;Austria | |||
| 24 | EUCTR2007-000638-37-BE (EUCTR) | 13/03/2008 | 27/02/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 25 | EUCTR2007-000638-37-NL (EUCTR) | 28/02/2008 | 29/11/2007 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 26 | NCT00603642 (ClinicalTrials.gov) | October 1, 2007 | 17/1/2008 | P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura | Drug: Placebo;Drug: AMG 531 | Amgen | NULL | Completed | 20 Years | N/A | All | 34 | Phase 3 | Japan |
| 27 | EUCTR2007-003569-42-ES (EUCTR) | 29/09/2007 | 03/08/2007 | Estudio Aleatorizado, Doble Ciego, Controlado con Placebo, de Fase 1/2 para Determinar la Seguridad y la Eficacia de AMG 531 en Sujetos Pediátricos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) Crónica | Estudio Aleatorizado, Doble Ciego, Controlado con Placebo, de Fase 1/2 para Determinar la Seguridad y la Eficacia de AMG 531 en Sujetos Pediátricos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) Crónica | Púrpura Trombocitopénica Inmune (Idiopática) (PTI) MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: proteína recombinante estimulante de la megacariopoyesis Product Code: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Spain | ||
| 28 | NCT00515203 (ClinicalTrials.gov) | July 2007 | 9/8/2007 | Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects | A Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura;Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Drug: Placebo;Drug: AMG 531 | Amgen | NULL | Completed | 1 Year | 17 Years | All | 22 | Phase 1/Phase 2 | Australia;Canada;Spain;United States |
| 29 | EUCTR2006-003700-18-PT (EUCTR) | 04/06/2007 | 06/02/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 30 | EUCTR2006-003700-18-CZ (EUCTR) | 25/05/2007 | 07/02/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy;Austria | |||
| 31 | EUCTR2006-003700-18-DE (EUCTR) | 08/05/2007 | 25/04/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Italy;Austria | |||
| 32 | EUCTR2006-003700-18-BE (EUCTR) | 26/03/2007 | 21/03/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Austria;Netherlands;Germany;Italy;United Kingdom;Portugal;France;Czech Republic;Belgium | ||
| 33 | EUCTR2006-003700-18-GB (EUCTR) | 08/03/2007 | 01/01/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Portugal;France;Czech Republic;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 34 | EUCTR2006-003700-18-AT (EUCTR) | 05/02/2007 | 21/12/2006 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 35 | EUCTR2006-003700-18-FR (EUCTR) | 31/01/2007 | 11/01/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Portugal;France;Czech Republic;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 36 | EUCTR2006-003700-18-NL (EUCTR) | 29/01/2007 | 12/09/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 37 | NCT00415532 (ClinicalTrials.gov) | December 1, 2006 | 21/12/2006 | Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open-label Study Evaluating the Efficacy and Tolerability of AMG 531 Versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects With Immune (Idiopathic) Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenic Purpura | Drug: Medical Standard of Care for ITP;Biological: Romiplostim | Amgen | NULL | Completed | 18 Years | N/A | All | 234 | Phase 3 | Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;Switzerland;United Kingdom;United States |
| 38 | NCT00102336 (ClinicalTrials.gov) | April 7, 2005 | 27/1/2005 | AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy | A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy | Thrombocytopenia;Idiopathic Thrombocytopenic Purpura | Biological: AMG 531;Drug: Placebo | Amgen | NULL | Completed | 18 Years | N/A | All | 62 | Phase 3 | United States |
| 39 | NCT00102323 (ClinicalTrials.gov) | March 29, 2005 | 27/1/2005 | AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy | A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy | Thrombocytopenia;Idiopathic Thrombocytopenic Purpura | Drug: Placebo;Biological: AMG 531 | Amgen | NULL | Completed | 18 Years | N/A | All | 63 | Phase 3 | France;Netherlands;Spain;United States |
| 40 | NCT00116688 (ClinicalTrials.gov) | August 2004 | 30/6/2005 | Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenia;Idiopathic Thrombocytopenic Purpura | Biological: Romiplostim | Amgen | NULL | Completed | 1 Year | N/A | All | 313 | Phase 3 | Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom;United States |
| 41 | NCT00111475 (ClinicalTrials.gov) | July 1, 2002 | 20/5/2005 | Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP) | A Dose-finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura | Drug: Romiplostim;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 65 Years | All | 45 | Phase 2 | NULL |