63. Idiopathic thrombocytopenic purpura Clinical trials / Disease details


Clinical trials : 363 Drugs : 212 - (DrugBank : 43) / Drug target genes : 47 - Drug target pathways : 138

  
13 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT05220878
(ClinicalTrials.gov)
September 9, 202121/1/2022Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With Chronic ITPMulticenter Randomized Double-blind Comparative Study of Clinical Efficacy and Safety of GNR-069 (JSC GENERIUM, Russia) and Nplate (Amgen Europe BV, The Netherlands) in Patients With Chronic Idiopathic Thrombocytopenic PurpuraIdiopathic Thrombocytopenic PurpuraBiological: GNR-069;Biological: NplateAO GENERIUMNULLRecruiting18 Years75 YearsAll160Phase 3Russian Federation
2EUCTR2010-019987-35-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
3EUCTR2010-019987-35-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
4EUCTR2010-019987-35-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
5EUCTR2010-019987-35-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
6EUCTR2008-004347-10-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
7EUCTR2010-019987-35-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
8EUCTR2008-004347-10-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
9EUCTR2008-004347-10-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
10EUCTR2008-004347-10-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
11EUCTR2008-004347-10-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
12EUCTR2008-004347-10-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
13EUCTR2008-004347-10-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