63. Idiopathic thrombocytopenic purpura
311 clinical trials,   185 drugs   (DrugBank: 39 drugs),   43 drug target genes,   132 drug target pathways

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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
52 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-001371-20-NL
(EUCTR)
06/05/201419/03/2014A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study)Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864
MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research and Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Hong Kong;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Netherlands;Tunisia;Germany;China;Korea, Republic of
2EUCTR2013-001371-20-PL
(EUCTR)
11/04/201424/02/2014A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study)Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864
MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
100United States;Hong Kong;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Netherlands;Tunisia;Germany;China;Korea, Republic of
3EUCTR2013-001371-20-GR
(EUCTR)
10/12/201311/11/2013A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study)Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864
MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research and Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Tunisia;Netherlands;Germany;China;Korea, Republic of
4EUCTR2013-001371-20-BE
(EUCTR)
15/10/201310/09/2013A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study)Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 17.0;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864
MedDRA version: 17.0;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Relovade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Relovade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research and Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Tunisia;Germany;China;Korea, Republic of
5EUCTR2013-001371-20-ES
(EUCTR)
15/10/201308/08/2013A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study)Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 16.0;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864
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] - Cancer [C04]
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Relovade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Relovade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany;Tunisia;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2013-001371-20-IE
(EUCTR)
06/09/201311/07/2013A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study)Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 14.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864
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] - Cancer [C04]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany;Tunisia;China;Korea, Republic of
7EUCTR2011-002184-17-DE
(EUCTR)
04/05/201213/12/2011Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body.A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period.
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: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Glaxosmithkline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
75United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany
8EUCTR2011-002184-17-PL
(EUCTR)
17/04/201208/03/2012Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body.A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period.
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: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Glaxosmithkline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
75United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany
9EUCTR2011-002184-17-IT
(EUCTR)
07/03/201208/03/2012Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body.A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP).PETIT2: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT2 To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period.
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: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
75United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Israel;Italy;United Kingdom;Argentina;Poland;Germany
10EUCTR2011-002184-17-ES
(EUCTR)
23/02/201221/12/2011Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body.A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP Pediatric patients with previously treated chronic immune (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: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Glaxosmithkline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Germany;Chile;Italy;Hong Kong;Israel;Czech Republic;Russian Federation;United Kingdom;Argentina;Taiwan;Spain;Thailand;United States;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2011-002184-17-CZ
(EUCTR)
08/02/201208/12/2011Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body.A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period.
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: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Glaxosmithkline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
75Phase 3United States;Hong Kong;Taiwan;Spain;Thailand;Chile;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany
12EUCTR2006-002946-13-NL
(EUCTR)
19/04/201115/12/2010A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETITA three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT Chronic Idiopathic Thrombocytopenic Purpura
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
70France;Spain;Netherlands;United Kingdom
13EUCTR2009-010421-39-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
14EUCTR2009-010421-39-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
15EUCTR2009-010421-39-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
16EUCTR2009-010421-39-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
17EUCTR2006-002946-13-FR
(EUCTR)
18/09/200905/08/2009A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETITA three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT Chronic Idiopathic Thrombocytopenic Purpura
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70United Kingdom;Netherlands;France;Spain
18EUCTR2006-002946-13-ES
(EUCTR)
30/07/200906/07/2009A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITPEstudio abierto, doble ciego, aleatorizado, controlado con placebo, de cohortes escalonadas , con tres partes para investigar la eficacia, seguridad, tolerabilidad y farmacocinética de eltrombopag, un agonista del receptor de trombopoyetina, en pacientes pediátricos con púrpura trombocitopénica idiopática (PTI) crónica previamente tratados.Eltrombopag PETIT: Eltrombopag en pacientes pediátricos con trombocitopenia por PTI (Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP) - PETITA three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITPEstudio abierto, doble ciego, aleatorizado, controlado con placebo, de cohortes escalonadas , con tres partes para investigar la eficacia, seguridad, tolerabilidad y farmacocinética de eltrombopag, un agonista del receptor de trombopoyetina, en pacientes pediátricos con púrpura trombocitopénica idiopática (PTI) crónica previamente tratados.Eltrombopag PETIT: Eltrombopag en pacientes pediátricos con trombocitopenia por PTI (Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP) - PETIT Chronic Idiopathic Thrombocytopenic PurpuraPúrpura Trombocitopénica Idiopática Crónica
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
GlaxoSmithKline S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15United Kingdom;Netherlands;France;Spain
19EUCTR2006-000471-14-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
20EUCTR2006-000471-14-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2006-000471-14-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
22EUCTR2006-000471-14-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
23EUCTR2006-000471-14-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
24EUCTR2006-000471-14-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
25EUCTR2006-000470-78-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT00540423
(ClinicalTrials.gov)
September 20075/10/2007Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) -A Multicenter Study in Subjects With Chronic ITP Receiving a Double-Blind, Placebo-Controlled, Short-Term Treatment Followed by an Open-Label, Uncontrolled, Long-Term Treatment- Chronic Idiopathic Thrombocytopenic Purpura;Purpura, Thrombocytopenic, IdiopathicDrug: SB-497115-GR 12.5mg;Drug: SB-497115-GR 25mg;Drug: SB-497115-GR 12.5mg matching placebo;Drug: SB-497115-GR 50 mgGlaxoSmithKlineNULLCompleted20 YearsN/AAll23Phase 3Japan
27EUCTR2006-000471-14-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
28EUCTR2006-002943-10-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
29EUCTR2006-002943-10-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
50Phase 2Spain;Germany;United Kingdom
30EUCTR2006-000470-78-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2006-002943-10-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
32NCT00424177
(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
33EUCTR2006-000471-14-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
34EUCTR2006-000470-78-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
35EUCTR2006-000471-14-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2006-000470-78-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
37EUCTR2006-000470-78-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
38EUCTR2006-000470-78-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
189Phase 3France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
39EUCTR2006-000470-78-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
40EUCTR2006-000470-78-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2006-000470-78-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
42EUCTR2006-000470-78-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
189Phase 3France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;Italy;United Kingdom
43EUCTR2006-000470-78-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
44NCT00370331
(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
45EUCTR2006-000470-78-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2006-000471-14-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
400Phase 3Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
47EUCTR2006-000471-14-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
48EUCTR2006-000471-14-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
49EUCTR2006-000471-14-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
50EUCTR2006-000471-14-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT00351468
(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
52EUCTR2006-002946-13-Outside-EU/EEA
(EUCTR)
24/02/2012A study of a new medication, eltrombopag, for the treatment of childhood chronic immune thrombocytopenic purpura (ITP), a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body.A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT 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;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Other descriptive name: REVOLADE, PROMACTA
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Other descriptive name: REVOLADE, PROMACTA
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Other descriptive name: REVOLADE, PROMACTA
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Other descriptive name: REVOLADE, PROMACTA
GlaxoSmithKline Research & Development LimitedNULLNAFemale: yes
Male: yes
70Canada;United States