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

  
32 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT05325593
(ClinicalTrials.gov)
December 2, 20227/3/2022Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune ThrombocytopeniaA Multicentre, Randomized, Open-label Study of Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaDrug: romiplostim plus dexamethasone;Drug: DexamethasoneFundación Pública Andaluza para la gestión de la Investigación en SevillaNULLRecruiting18 YearsN/AAll126Phase 3Spain
2NCT02760251
(ClinicalTrials.gov)
April 201615/4/2016Immunomodulation With Romiplostim in Young Adults With ITPThrombopoietin-receptor Agonist-immunomodulation in Young Adult Primary Immune Thrombocytopenia (ITP): A Multi-center Open Label Trial With RomiplostimImmune ThrombocytopeniaDrug: romiplostimUniversity Hospital, Basel, SwitzerlandUniversity Children's Hospital BaselCompleted18 Years45 YearsAll15Phase 4Switzerland
3NCT02868099
(ClinicalTrials.gov)
September 201511/8/2016Efficacy 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 ThrombocytopeniaDrug: Romiplostim;Drug: PlaceboKyowa Hakko Kirin China Pharmaceutical Co.,LTD.NULLCompleted18 YearsN/AAll203Phase 3China
4EUCTR2010-019987-35-FR
(EUCTR)
26/06/201309/09/2010A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITPRemission Rates in Adult Subjects with Immune Thrombocytopenia Purpura ReceivingRomiplostimA 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 IncNULLNot RecruitingFemale: yes
Male: yes
75Phase 2France;Czech Republic;Spain;Germany;United Kingdom;Italy
5NCT01444417
(ClinicalTrials.gov)
January 201229/9/2011Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric PatientsA 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 ThrombocytopeniaDrug: Romiplostim;Drug: PlaceboAmgenNULLCompleted1 Year17 YearsAll62Phase 3United States;Australia;Canada
6EUCTR2010-019987-35-CZ
(EUCTR)
21/12/201026/11/2010Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving RomiplostimA 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 IncNULLNot RecruitingFemale: yes
Male: yes
75Phase 2France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy
7NCT01143038
(ClinicalTrials.gov)
November 30, 201010/6/2010Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving RomiplostimA Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving RomiplostimIdiopathic Thrombocytopenic PurpuraBiological: RomiplostimAmgenNULLCompleted18 YearsN/AAll75Phase 2United States;Australia;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom;Czech Republic
8EUCTR2010-019987-35-GB
(EUCTR)
29/10/201026/08/2010 Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving RomiplostimA 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 IncNULLNot 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): noFrance;United States;Czech Republic;Spain;Germany;Italy;United Kingdom
9EUCTR2010-019987-35-DE
(EUCTR)
21/10/201025/08/2010Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving RomiplostimA 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 IncNULLNot RecruitingFemale: yes
Male: yes
75Phase 2France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy
10EUCTR2008-004347-10-BG
(EUCTR)
14/10/201012/05/2010A 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 IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
11EUCTR2010-019987-35-ES
(EUCTR)
22/09/201031/08/2010Estudio 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 RomiplostimEstudio 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 IncNULLNot RecruitingFemale: yes
Male: yes
75Phase 2France;Czech Republic;Spain;Germany;United Kingdom;Italy
12NCT01071954
(ClinicalTrials.gov)
December 30, 200917/12/2009A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia PurpuraAn 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 ITPBiological: RomiplostimAmgenNULLCompleted1 YearN/AAll66Phase 3United States;Australia;Canada;Spain
13EUCTR2008-004347-10-SI
(EUCTR)
12/11/200906/10/2009A 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 IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
14EUCTR2008-004347-10-IT
(EUCTR)
07/10/200916/09/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
15EUCTR2008-004347-10-SE
(EUCTR)
09/09/200924/06/2009A 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 IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
16NCT00907478
(ClinicalTrials.gov)
August 11, 200921/5/2009Study 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 PurpuraBiological: romiplostimAmgenNULLCompleted18 YearsN/AAll169Phase 4Australia;Austria;Belgium;Canada;Czech Republic;Estonia;Germany;Hungary;Italy;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovenia;Spain;Sweden;United States
17EUCTR2008-004347-10-ES
(EUCTR)
16/07/200905/06/2009A 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 IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
18EUCTR2008-004347-10-BE
(EUCTR)
10/07/200929/05/2009A 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 IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Sweden
19EUCTR2008-004347-10-AT
(EUCTR)
17/06/200906/05/2009A 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 IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
20NCT00902018
(ClinicalTrials.gov)
January 20098/5/2009Eltrombopag 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) PathwayImmune ThrombocytopeniaDrug: Eltrombopag;Drug: Romiplostim;Other: healthy controlsWeill Medical College of Cornell UniversityGlaxoSmithKlineCompleted18 YearsN/AAll20Phase 2United States
21EUCTR2007-000638-37-ES
(EUCTR)
17/12/200817/10/2008An 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.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Czech Republic;Netherlands;Belgium;Ireland;Spain;Italy;Austria
22EUCTR2007-000638-37-SK
(EUCTR)
17/12/200827/10/2008An 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.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2Czech Republic;Slovakia;Spain;Belgium;Ireland;Austria;Netherlands;Italy;United Kingdom
23EUCTR2007-000638-37-GB
(EUCTR)
18/08/200811/04/2008An 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.NULLNot RecruitingFemale: yes
Male: yes
500Czech Republic;United Kingdom;Netherlands;Belgium;Spain;Ireland;Italy;Austria
24EUCTR2007-000638-37-AT
(EUCTR)
30/04/200804/03/2008An 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.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
25EUCTR2007-000638-37-CZ
(EUCTR)
09/04/200811/02/2008An 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.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
26EUCTR2007-000638-37-BE
(EUCTR)
13/03/200827/02/2008An 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.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
27EUCTR2007-000638-37-NL
(EUCTR)
28/02/200829/11/2007An 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.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
28NCT00515203
(ClinicalTrials.gov)
July 20079/8/2007Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric SubjectsA 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 PurpuraIdiopathic 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 531AmgenNULLCompleted1 Year17 YearsAll22Phase 1/Phase 2Australia;Canada;Spain;United States
29NCT00415532
(ClinicalTrials.gov)
December 1, 200621/12/2006Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic PurpuraA 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 PurpuraIdiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenic PurpuraDrug: Medical Standard of Care for ITP;Biological: RomiplostimAmgenNULLCompleted18 YearsN/AAll234Phase 3Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;Switzerland;United Kingdom;United States
30NCT00508820
(ClinicalTrials.gov)
February 1, 200526/7/2007An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITPAn Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)Idiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenic PurpuraBiological: RomiplostimAmgenNULLCompleted18 YearsN/AAll407Phase 3Australia;Austria;Belgium;Canada;Czech Republic;Ireland;Italy;Netherlands;Poland;Slovakia;Spain;Switzerland;United Kingdom;United States
31NCT00116688
(ClinicalTrials.gov)
August 200430/6/2005Open 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 PurpuraBiological: RomiplostimAmgenNULLCompleted1 YearN/AAll313Phase 3Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom;United States
32NCT00111475
(ClinicalTrials.gov)
July 1, 200220/5/2005Evaluating 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 PurpuraDrug: Romiplostim;Drug: PlaceboAmgenNULLCompleted18 Years65 YearsAll45Phase 2NULL