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

  
41 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-019987-35-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
2EUCTR2010-019987-35-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
3EUCTR2010-019987-35-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
4EUCTR2010-019987-35-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
5EUCTR2008-004347-10-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
6EUCTR2008-004347-10-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
7EUCTR2008-004347-10-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
8EUCTR2008-004347-10-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
9EUCTR2008-004347-10-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
10EUCTR2008-004347-10-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
11EUCTR2007-000638-37-IE
(EUCTR)
06/01/200910/04/2008An 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.NULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
12EUCTR2007-000638-37-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
13EUCTR2007-000638-37-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
14EUCTR2004-000172-13-GB
(EUCTR)
20/08/200811/02/2005An 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 availableAn 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 531Amgen Inc.NULLNot 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): noCzech Republic;Belgium;Austria;Germany;Italy;United Kingdom
15EUCTR2007-000638-37-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
16EUCTR2004-000172-13-IT
(EUCTR)
22/07/200810/07/2008AN OPEN LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF LONG-TERM DOSING OF AMG 531 IN THROMBOCYTOPENIC SUBJECTS WITH IMMUNE (IDIOPATHIC) THROMBOCITOPENIC PURPURAAN 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.NULLNot RecruitingFemale: yes
Male: yes
350Czech Republic;Belgium;Austria;Germany;United Kingdom;Italy
17EUCTR2004-000172-13-CZ
(EUCTR)
11/06/200811/04/2008An 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 availableAn 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 531Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
350Germany;United Kingdom;Czech Republic;Belgium;Italy;Austria
18EUCTR2007-000638-37-IT
(EUCTR)
09/06/200804/08/2008An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209An 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.NULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
19EUCTR2004-000172-13-AT
(EUCTR)
13/05/200810/03/2008An 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 availableAn 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 531Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
350Czech Republic;Germany;United Kingdom;Belgium;Italy;Austria
20EUCTR2004-000172-13-DE
(EUCTR)
07/05/200807/02/2008An 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 availableAn 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 531Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
350Czech Republic;United Kingdom;Germany;Belgium;Italy;Austria
21EUCTR2007-000638-37-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
22EUCTR2007-000638-37-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
23EUCTR2004-000172-13-BE
(EUCTR)
08/04/200827/02/2008An 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 availableAn 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 531Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
350Czech Republic;Germany;United Kingdom;Belgium;Italy;Austria
24EUCTR2007-000638-37-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
25EUCTR2007-000638-37-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
26NCT00603642
(ClinicalTrials.gov)
October 1, 200717/1/2008P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic PurpuraIdiopathic Thrombocytopenic PurpuraDrug: Placebo;Drug: AMG 531AmgenNULLCompleted20 YearsN/AAll34Phase 3Japan
27EUCTR2007-003569-42-ES
(EUCTR)
29/09/200703/08/2007Estudio 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) CrónicaEstudio 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.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2Spain
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
29EUCTR2006-003700-18-PT
(EUCTR)
04/06/200706/02/2007A 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 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 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.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
30EUCTR2006-003700-18-CZ
(EUCTR)
25/05/200707/02/2007A 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 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 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.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy;Austria
31EUCTR2006-003700-18-DE
(EUCTR)
08/05/200725/04/2007A 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 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 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.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Italy;Austria
32EUCTR2006-003700-18-BE
(EUCTR)
26/03/200721/03/2007A 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 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 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.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3Austria;Netherlands;Germany;Italy;United Kingdom;Portugal;France;Czech Republic;Belgium
33EUCTR2006-003700-18-GB
(EUCTR)
08/03/200701/01/2007A 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 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 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.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3Portugal;France;Czech Republic;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom
34EUCTR2006-003700-18-AT
(EUCTR)
05/02/200721/12/2006A 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 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 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.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
35EUCTR2006-003700-18-FR
(EUCTR)
31/01/200711/01/2007A 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 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 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.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3Portugal;France;Czech Republic;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom
36EUCTR2006-003700-18-NL
(EUCTR)
29/01/200712/09/2007A 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 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 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.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
37NCT00415532
(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
38NCT00102336
(ClinicalTrials.gov)
April 7, 200527/1/2005AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to SplenectomyA Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to SplenectomyThrombocytopenia;Idiopathic Thrombocytopenic PurpuraBiological: AMG 531;Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll62Phase 3United States
39NCT00102323
(ClinicalTrials.gov)
March 29, 200527/1/2005AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to SplenectomyA Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to SplenectomyThrombocytopenia;Idiopathic Thrombocytopenic PurpuraDrug: Placebo;Biological: AMG 531AmgenNULLCompleted18 YearsN/AAll63Phase 3France;Netherlands;Spain;United States
40NCT00116688
(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
41NCT00111475
(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