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 | NCT05325593 (ClinicalTrials.gov) | December 2, 2022 | 7/3/2022 | Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia | A Multicentre, Randomized, Open-label Study of Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia | Drug: romiplostim plus dexamethasone;Drug: Dexamethasone | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | NULL | Recruiting | 18 Years | N/A | All | 126 | Phase 3 | Spain |
| 2 | NCT02760251 (ClinicalTrials.gov) | April 2016 | 15/4/2016 | Immunomodulation With Romiplostim in Young Adults With ITP | Thrombopoietin-receptor Agonist-immunomodulation in Young Adult Primary Immune Thrombocytopenia (ITP): A Multi-center Open Label Trial With Romiplostim | Immune Thrombocytopenia | Drug: romiplostim | University Hospital, Basel, Switzerland | University Children's Hospital Basel | Completed | 18 Years | 45 Years | All | 15 | Phase 4 | Switzerland |
| 3 | NCT02868099 (ClinicalTrials.gov) | September 2015 | 11/8/2016 | Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP) | A Multi-center, Randomized, Placebo-controlled, Double-blinded Then Open 2 Stages Clinical Trial to Evaluate the Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia | Drug: Romiplostim;Drug: Placebo | Kyowa Hakko Kirin China Pharmaceutical Co.,LTD. | NULL | Completed | 18 Years | N/A | All | 203 | Phase 3 | China |
| 4 | 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 | ||
| 5 | NCT01444417 (ClinicalTrials.gov) | January 2012 | 29/9/2011 | Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients | A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Determine the Safety and Efficacy of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP) | Idiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenic Purpura;Immune Thrombocytopenia | Drug: Romiplostim;Drug: Placebo | Amgen | NULL | Completed | 1 Year | 17 Years | All | 62 | Phase 3 | United States;Australia;Canada |
| 6 | 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 | ||
| 7 | NCT01143038 (ClinicalTrials.gov) | November 30, 2010 | 10/6/2010 | Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) 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 | Idiopathic Thrombocytopenic Purpura | Biological: Romiplostim | Amgen | NULL | Completed | 18 Years | N/A | All | 75 | Phase 2 | United States;Australia;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom;Czech Republic |
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | EUCTR2010-019987-35-ES (EUCTR) | 22/09/2010 | 31/08/2010 | Estudio de fase 2, intervencionista, de un solo brazo para describir la respuesta plaquetaria y las tasas de remisión de PTI en sujetos adultos con Púrpura Trombocitopénica Inmune que reciben Romiplostim.-------------------------------------------------------A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim | Estudio de fase 2, intervencionista, de un solo brazo para describir la respuesta plaquetaria y las tasas de remisión de PTI en sujetos adultos con Púrpura Trombocitopénica Inmune que reciben Romiplostim.-------------------------------------------------------A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim | Púrpura Trombocitopénica Inmune(Idiopática) (PTI) en adultos----------------------------------Adult immune thrombocytopenic purpura (ITP) MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: NPLATE 500 microgramos polvo para solución inyectable INN or Proposed INN: ROMIPLOSTIM Other descriptive name: ROMIPLOSTIM | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | France;Czech Republic;Spain;Germany;United Kingdom;Italy | ||
| 12 | NCT01071954 (ClinicalTrials.gov) | December 30, 2009 | 17/12/2009 | A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura | An Open Label Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP | Biological: Romiplostim | Amgen | NULL | Completed | 1 Year | N/A | All | 66 | Phase 3 | United States;Australia;Canada;Spain |
| 13 | 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 | ||
| 14 | EUCTR2008-004347-10-IT (EUCTR) | 07/10/2009 | 16/09/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP. | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP. | Thrombocytopenia associated 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] | Trade Name: NPLATE 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 | ||
| 15 | 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 | ||
| 16 | NCT00907478 (ClinicalTrials.gov) | August 11, 2009 | 21/5/2009 | Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated With Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia;Idiopathic Thrombocytopenic Purpura | Biological: romiplostim | Amgen | NULL | Completed | 18 Years | N/A | All | 169 | Phase 4 | Australia;Austria;Belgium;Canada;Czech Republic;Estonia;Germany;Hungary;Italy;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovenia;Spain;Sweden;United States |
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | NCT00902018 (ClinicalTrials.gov) | January 2009 | 8/5/2009 | Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP) | The Effect of Eltrombopag on Platelet Survival: the Role of the B-cell L Extra Large (BcL-xL) Pathway | Immune Thrombocytopenia | Drug: Eltrombopag;Drug: Romiplostim;Other: healthy controls | Weill Medical College of Cornell University | GlaxoSmithKline | Completed | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 21 | 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 | ||
| 22 | 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 | |||
| 23 | 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 | |||
| 24 | 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 | |||
| 25 | 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 | |||
| 26 | 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 | |||
| 27 | 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 | |||
| 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 | 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 |
| 30 | NCT00508820 (ClinicalTrials.gov) | February 1, 2005 | 26/7/2007 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenic Purpura | Biological: Romiplostim | Amgen | NULL | Completed | 18 Years | N/A | All | 407 | Phase 3 | Australia;Austria;Belgium;Canada;Czech Republic;Ireland;Italy;Netherlands;Poland;Slovakia;Spain;Switzerland;United Kingdom;United States |
| 31 | 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 |
| 32 | 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 |