Romiplostim ( DrugBank: Romiplostim )

4 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
60	再生不良性貧血	8
63	特発性血小板減少性紫斑病	32
64	血栓性血小板減少性紫斑病	1
65	原発性免疫不全症候群	2

60. 再生不良性貧血

臨床試験数 : 245 / 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166

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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	NCT05323617 (ClinicalTrials.gov)	May 15, 2023	5/4/2022	Efficacy of Romiplostimin Treatment of SAA in Adults Previously Untreated With or Refractory to Immu ...	Two Arm Bridging Study to Evaluate the Efficacy of Romiplostimin the Treatment of Adult Severe Aplas ...	Severe Aplastic Anemia (SAA)	Drug: Romiplostim;Drug: Antithymocyte Globulin;Drug: Cyclosporine A	Amgen	NULL	Not yet recruiting	18 Years	N/A	All	40	Phase 2	NULL
2	NCT04478227 (ClinicalTrials.gov)	August 18, 2020	10/7/2020	TPO-Mimetic Use in Children for Hematopoietic Failure	Single Arm Prospective Open Label Pilot Study Evaluating Short-Term Safety and Efficacy of Romiplost ...	Bone Marrow Failure Disorders;Aplastic Anemia;Thrombocytopenia;Refractory Cytopenia of Childhood;Mye ...	Drug: Romiplostim	Anjali Sharathkumar	Amgen	Recruiting	0 Years	21 Years	All	25	Early Phase 1	United States
3	JPRN-JapicCTI-194962	03/12/2019	18/09/2019	A Phase 2/3 Study of AMG531 in Patients with Aplastic Anemia	A Phase 2/3 Study of AMG531 Combined with Ciclosporin A in Patients with Aplastic Anemia Previously ...	Aplastic Anemia	Intervention name : AMG531 INN of the intervention : romiplostim Dosage And administration of the inte ...	Kyowa Kirin Co., Ltd	NULL	complete	20		BOTH	24	Phase 2-3	Japan, Asia except Japan
4	NCT04095936 (ClinicalTrials.gov)	December 3, 2019	18/9/2019	Study of AMG531 (Romiplostim) in Patients With Aplastic Anemia	A Phase 2/3 Study of AMG531 Combined With Ciclosporin A in Patients With Aplastic Anemia Previously ...	Aplastic Anemia	Drug: Romiplostim	Kyowa Kirin Co., Ltd.	NULL	Completed	20 Years	N/A	All	24	Phase 2/Phase 3	Japan
5	NCT03957694 (ClinicalTrials.gov)	April 25, 2019	9/5/2019	Study of AMG531(Romiplostim) in Patients With Aplastic Anemia	A Phase 2/3 Study of AMG531 in Patients With Aplastic Anemia PreviouslyUntreated With Immunosuppress ...	Aplastic Anemia	Drug: Romiplostim	Kyowa Kirin Co., Ltd.	NULL	Completed	20 Years	N/A	All	17	Phase 2/Phase 3	Japan
6	JPRN-JapicCTI-194746	01/2/2019	09/05/2019	A Phase 2/3 Study of AMG531 in Patients with Aplastic Anemia	A Phase 2/3 Study of AMG531 in Patients with Aplastic Anemia Previously Untreated with Immunosuppres ...	Aplastic Anemia	Intervention name : AMG531 INN of the intervention : romiplostim Dosage And administration of the inte ...	Kyowa Kirin Co., Ltd	NULL	complete	20		BOTH	14	Phase 2-3	Japan, Asia except Japan
7	NCT02773290 (ClinicalTrials.gov)	May 2016	9/5/2016	Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia	Phase 2/3 Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia Refractory to or Ineligible ...	Aplastic Anemia	Biological: Romiplostim	Kyowa Kirin Co., Ltd.	NULL	Completed	20 Years	N/A	All	46	Phase 2/Phase 3	Japan;Korea, Republic of
8	JPRN-JapicCTI-163243	01/2/2016	02/05/2016	Phase 2/3 Study of AMG531 in Subjects with Aplastic Anemia	Phase 2/3 Study of AMG531 in Subjects with Aplastic Anemia Refractory to or Ineligible for Immunosup ...	Aplastic Anemia	Intervention name : AMG531 INN of the intervention : Romiplostim Dosage And administration of the inte ...	Kyowa Hakko Kirin Co., Ltd.	NULL	complete	20		BOTH	46	Phase 2-3	NULL

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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

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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	RomiplostimPlus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Throm ...	A Multicentre, Randomized, Open-label Study of RomiplostimPlus Dexamethasone vs Dexamethasone in Pat ...	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 ...	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 Romiplostimin Adult Subjects With Persistent or Chronic Immune Thrombocytopen ...	A Multi-center, Randomized, Placebo-controlled, Double-blinded Then Open 2 Stages Clinical Trial to ...	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 ...	A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITPRemission Rates in ...	Adult immune thrombocytopenic purpura (ITP) MedDRA version: 12.1;Level: LLT;Classification code 1002 ...	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 Romiplostimto Treat Immune Thrombocytopenia (ITP) in Pediatric Patients ...	A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Determine the Safety and Efficacy of ...	Idiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenia in Pediatric Subjects With Imm ...	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 immune thrombocytopenic purpura (ITP) MedDRA version: 16.0;Level: PT;Classification code 10021 ...	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 A ...	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 immune thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021 ...	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 - ( ...	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 immune thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021 ...	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 ...	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology ...	Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Ter ...	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;German ...

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64. 血栓性血小板減少性紫斑病

臨床試験数 : 92 / 薬物数 : 85 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 76

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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	NCT04588194 (ClinicalTrials.gov)	November 1, 2020	30/1/2020	Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia	Romiplostimin Combination With Low-dose Rituximab and High-dose Dexamethasone as Frontline Treatment ...	Immune Thrombocytopenia;Thrombotic Thrombocytopenic Purpura	Drug: Romiplostim;Drug: Rituximab;Drug: Dexamethasone	David Gomez Almaguer	NULL	Recruiting	16 Years	90 Years	All	12	Phase 2	Mexico

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65. 原発性免疫不全症候群

臨床試験数 : 500 / 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217

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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	NCT04371939 (ClinicalTrials.gov)	November 5, 2019	29/4/2020	Efficacy and Safety of RomiplostimVersus Eltrombopag in the Treatment of Thrombocytopenia in Patient ...	Randomized, Two-arm Single-center Phase II Clinical Trial Comparing the Efficacy and Safety of Romip ...	Wiskott-Aldrich Syndrome	Drug: Romiplostim;Drug: Eltrombopag	Federal Research Institute of Pediatric Hematology, Oncology and Immunology	NULL	Recruiting	N/A	18 Years	All	30	Phase 2	Russian Federation
2	NCT04350164 (ClinicalTrials.gov)	April 1, 2012	10/4/2020	Romiplostim Treatment for Thrombocytopenia in Patients With Wiskott-Aldrich Syndrome.	Retrospective Chart Review of Children With Wiskott-Aldrich Syndrome Who Received Romiplostimin Trea ...	Wiskott-Aldrich Syndrome	Drug: Romiplostim	Federal Research Institute of Pediatric Hematology, Oncology and Immunology	NULL	Active, not recruiting	N/A	18 Years	All	67		Russian Federation

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