Eltrombopag olamine    (DrugBank: Eltrombopag)

2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
60再生不良性貧血1
63特発性血小板減少性紫斑病43

60. 再生不良性貧血 [臨床試験数:218,薬物数:362(DrugBank:81),標的遺伝子数:39,標的パスウェイ数:155
Searched query = "Aplastic anemia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 218 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-000174-19-DE
(EUCTR)
27/01/201501/09/2014Efficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopag with Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin AEfficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopagwith Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A - EMAA Moderate Aplastic Anemia (MAA);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Trade Name: Revolade 75 mg
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: Eltrombopag
Other descriptive name: ELTROMBOPAG OLAMINE
Universitätsklinikum UlmNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2;Phase 3France;Netherlands;Germany;Italy;Switzerland

63. 特発性血小板減少性紫斑病 [臨床試験数:311,薬物数:185(DrugBank:39),標的遺伝子数:43,標的パスウェイ数:132
Searched query = "Idiopathic thrombocytopenic purpura", "Primary immune thrombocytopenia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
43 / 311 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-001327-23-IT
(EUCTR)
26/06/201529/04/2015Study about the effect of a drug (Eltrombopag)which is administered in patients with thrombocytopenia primary Immune, a relative decrease of platelets in blood (small blood components that help the clotting process by sticking to the lining of blood vessels).Eltrombopag as Second line Therapy in adult patients with primary Immune Thrombocytopenia (ESTIT study) in an attempt to achieve long-term remission: a single arm multicenter phase II clinical and biological study Primary Immune Thrombocytopenia
MedDRA version: 18.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Revolade
Product Name: Revolade
INN or Proposed INN: NA
Other descriptive name: ELTROMBOPAG OLAMINE
Trade Name: Revolade
Product Name: Revolade
INN or Proposed INN: NA
Other descriptive name: ELTROMBOPAG OLAMINE
Fondazione G.I.M.EM.A. Gruppo Italiano Malattie Ematologiche dell'AdultoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 2Italy
2EUCTR2011-000831-10-DE
(EUCTR)
18/07/201216/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;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 maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
3EUCTR2011-000831-10-BE
(EUCTR)
16/07/201215/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;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 maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
4EUCTR2011-000831-10-GB
(EUCTR)
02/07/201228/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;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 maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
5EUCTR2011-000831-10-AT
(EUCTR)
05/06/201216/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;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 maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2011-000831-10-ES
(EUCTR)
25/05/201229/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;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 maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
7EUCTR2011-000831-10-NL
(EUCTR)
24/05/201224/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;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 maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden;Korea, Republic of
8EUCTR2009-010421-39-FR
(EUCTR)
25/05/201009/03/2010A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP).A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). Chronic Idiopathic Thrombocytopenic Purpura
MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: eltrombopag (Revolade)
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: eltrombopag (Revolade)
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: eltrombopag (Revolade)
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: eltrombopag (Revolade)
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 4France;Hungary;Czech Republic;Germany;Italy
9EUCTR2009-010421-39-CZ
(EUCTR)
06/05/201003/03/2010A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP).A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). Chronic Idiopathic Thrombocytopenic Purpura
MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKlineNULLNot RecruitingFemale: yes
Male: yes
150France;Hungary;Czech Republic;Germany;Italy
10EUCTR2009-010421-39-HU
(EUCTR)
05/05/201010/03/2010A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP).A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). Chronic Idiopathic Thrombocytopenic Purpura
MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKlineNULLNot RecruitingFemale: yes
Male: yes
150France;Czech Republic;Hungary;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2009-010421-39-DE
(EUCTR)
10/03/201004/02/2010A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP).A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). Chronic Idiopathic Thrombocytopenic Purpura
MedDRA version: 15.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKlineNULLNot RecruitingFemale: yes
Male: yes
200France;Hungary;Czech Republic;Germany;Italy
12EUCTR2006-000471-14-IE
(EUCTR)
02/08/200805/07/2006EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND Immune thrombocytopenic purpura (ITP)Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: Eltrombopag
INN or Proposed INN: Eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 4Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
13EUCTR2006-000471-14-FI
(EUCTR)
30/11/200708/10/2007EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
400Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
14EUCTR2006-000471-14-IT
(EUCTR)
16/11/200713/09/2007EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study. - TRA105325EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study. - TRA105325 Idiopathic thrombocytopenic purpura
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB-497115-GR
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115-GR
INN or Proposed INN: Eltrombopag
GLAXOSMITHKLINE R&D LTDNULLNot RecruitingFemale: yes
Male: yes
200Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
15EUCTR2006-000471-14-AT
(EUCTR)
11/11/200723/10/2007EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2006-000471-14-DE
(EUCTR)
26/10/200730/05/2006EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
17EUCTR2006-000470-78-CZ
(EUCTR)
01/10/200730/11/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
18EUCTR2006-000471-14-DK
(EUCTR)
01/10/200714/08/2007EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
19EUCTR2006-000471-14-CZ
(EUCTR)
16/08/200724/07/2007EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND 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
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
20EUCTR2006-002943-10-ES
(EUCTR)
19/04/200721/02/2007REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEATREPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Germany;United Kingdom;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2006-002943-10-GB
(EUCTR)
13/04/200726/02/2007 REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Germany;United Kingdom
22EUCTR2006-000470-78-GR
(EUCTR)
27/03/200703/01/2007A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
23EUCTR2006-002943-10-DE
(EUCTR)
16/03/200728/03/2007REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEATREPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
50United Kingdom;Germany;Spain
24NCT00424177
(ClinicalTrials.gov)
March 200717/1/2007Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT)An Open-label Repeat Dosing Study of Eltrombopag Olamine (SB-497115-GR) in Adult Subjects, With Chronic Idiopathic Thrombocytopenic Purpura (ITP)Purpura, Thrombocytopaenic, IdiopathicDrug: eltrombopagGlaxoSmithKlineNULLCompleted18 YearsN/AAll66Phase 2Germany;Russian Federation;Australia;Canada;India;Korea, Republic of;Netherlands;Spain;Tunisia;United Kingdom;United States
25EUCTR2006-000471-14-GR
(EUCTR)
27/02/200704/09/2006EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND Immune thrombocytopenic purpura (ITP)Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: Eltrombopag
INN or Proposed INN: Eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2006-000470-78-DE
(EUCTR)
14/02/200705/12/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Czech Republic;Germany;Netherlands;France;Spain;Italy;Greece;Austria
27EUCTR2006-000471-14-SK
(EUCTR)
23/01/200730/11/2006Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial.EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND chronic immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 17.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden
28EUCTR2006-000470-78-IT
(EUCTR)
17/01/200705/02/2007RAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with EltrombopagRAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with Eltrombopag Idiopathic thrombocytopenic purpura ITP
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB-497115-GR
Product Name: Eltrombopag
Product Code: SB-497115-GR
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
29EUCTR2006-000470-78-SK
(EUCTR)
17/01/200730/11/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
30EUCTR2006-000470-78-FR
(EUCTR)
22/12/200616/11/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
189 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2006-000470-78-FI
(EUCTR)
12/12/200625/10/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
32EUCTR2006-000470-78-DK
(EUCTR)
29/11/200610/11/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3France;Czech Republic;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
33EUCTR2006-000470-78-GB
(EUCTR)
22/11/200608/05/2008A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
189 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;Italy;United Kingdom
34EUCTR2006-000470-78-ES
(EUCTR)
22/11/200613/04/2012A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP).A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic 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] - Immune System Diseases [C20]
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
189Phase 3Germany;France;Hong Kong;Austria;Brazil;Czech Republic;Tunisia;Canada;New Zealand;Peru;Greece;United States;Poland;Netherlands;Italy;Vietnam;Finland;India;Russian Federation;Slovakia;United Kingdom;Denmark;Taiwan;Estonia;China;Spain
35EUCTR2006-000470-78-AT
(EUCTR)
22/11/200620/11/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT00370331
(ClinicalTrials.gov)
November 200629/8/2006RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With EltrombopagA Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy, Safety and Tolerability of Eltrombopag Olamine (SB-497115-GR), a Thrombopoietin Receptor Agonist, Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP.Purpura, Thrombocytopaenic, IdiopathicDrug: eltrombopag;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 YearsN/AAll197Phase 3United States;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;India;Italy;Netherlands;New Zealand;Peru;Poland;Russian Federation;Slovakia;Spain;Taiwan;Tunisia;Ukraine;United Kingdom;Vietnam;Estonia
37EUCTR2006-000470-78-NL
(EUCTR)
30/10/200601/09/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
38EUCTR2006-000471-14-GB
(EUCTR)
23/10/200603/06/2007EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND Immune Thrombocytopenic Purpura (ITP)
MedDRA version: 12.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSlovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
39EUCTR2006-000471-14-NL
(EUCTR)
23/08/200621/07/2006EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Germany;Sweden
40EUCTR2006-000471-14-SE
(EUCTR)
14/08/200629/05/2006Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial.EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND chronic immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 18.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2006-000471-14-FR
(EUCTR)
16/06/200624/11/2006EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
42EUCTR2006-000471-14-SI
(EUCTR)
13/06/200623/05/2006EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND Immune thrombocytopenic purpura (ITP)Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: Eltrombopag
INN or Proposed INN: Eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Slovenia;Denmark;Spain;Greece
43NCT00351468
(ClinicalTrials.gov)
June 200610/7/2006EXTEND (Eltrombopag Extended Dosing Study)EXTEND (Eltrombopag Extended Dosing Study): An Extension Study of Eltrombopag Olamine (SB-497115-GR) in Adults, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study.Purpura, Thrombocytopaenic, IdiopathicDrug: eltrombopag olamine (SB-497115-GR)Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll302Phase 3United States;Australia;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Italy;Korea, Republic of;Netherlands;New Zealand;Pakistan;Peru;Poland;Romania;Russian Federation;Slovakia;Slovenia;Spain;Sweden;Taiwan;Thailand;Tunisia;Ukraine;United Kingdom;Vietnam;India;Ireland;Mexico;Norway