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 : 363 薬物数 : 212 - (DrugBank : 43) / 標的遺伝子数 : 47 - 標的パスウェイ数 : 138

  
17 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
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size
PhaseCountries
1EUCTR2011-000830-12-GR
(EUCTR)
16/11/201208/10/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 15.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 15.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Hong Kong;Slovakia;Greece;Ukraine;Czech Republic;Poland;Belgium;Singapore;Romania;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China
2EUCTR2011-000830-12-NL
(EUCTR)
28/08/201223/08/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 16.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Czech Republic;Slovakia;Greece;Belgium;Poland;Ukraine;Singapore;Australia;Bulgaria;South Africa;Netherlands;New Zealand
3NCT01433978
(ClinicalTrials.gov)
March 26, 201213/9/2011A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)Idiopathic Thrombocytopenic PurpuraDrug: Eltrombopag;Drug: Avatrombopag;Drug: Standard of careEisai Inc.NULLTerminated18 Years99 YearsAll24Phase 3United States
4EUCTR2011-000830-12-CZ
(EUCTR)
19/01/201203/11/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Czech Republic;Slovakia;Greece;Poland;Belgium;Ukraine;Singapore;Australia;South Africa;Bulgaria;Netherlands;New Zealand
5EUCTR2011-000830-12-PL
(EUCTR)
16/01/201217/11/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 16.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Slovakia;Greece;Ukraine;Austria;Czech Republic;Poland;Belgium;Singapore;Romania;South Africa;Bulgaria;Netherlands;New Zealand
6EUCTR2011-000830-12-BE
(EUCTR)
30/12/201120/09/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Hungary;Czech Republic;Belgium;Poland;Portugal;Hong Kong;Slovakia;Greece;Ukraine;Singapore;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China
7EUCTR2011-000830-12-BG
(EUCTR)
21/12/201112/12/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Portugal;Hong Kong;Slovakia;Greece;Ukraine;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;South Africa;Netherlands;New Zealand;China
8EUCTR2011-000830-12-SK
(EUCTR)
28/09/201126/08/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Portugal;Slovakia;Greece;Ukraine;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China
9EUCTR2006-003700-18-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
10EUCTR2006-003700-18-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
11EUCTR2006-003700-18-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
12EUCTR2006-003700-18-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
13EUCTR2006-003700-18-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
14EUCTR2006-003700-18-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
15EUCTR2006-003700-18-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
16EUCTR2006-003700-18-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
17NCT00415532
(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