63. 特発性血小板減少性紫斑病 Idiopathic thrombocytopenic purpura Clinical trials / Disease details


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139

  
27 trials found
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
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PhaseCountries
1NCT04812483
(ClinicalTrials.gov)
September 1, 20221/3/2021Immunomodulation With Eltrombopag in ITPImmunomodulation in Young and Midlife Adults With Newly Diagnosed Primary Immune Thrombocytopenia (ITP): A Randomized Open Label Trial With High-dose Dexamethasone Versus Eltrombopag and High-dose DexamethasonePrimary Immune Thrombocytopenia (ITP)Drug: Eltrombopag (Revolade®);Drug: standard therapy (without eltrombopag): HD-DXMUniversity Children's Hospital BaselStiftung zur Förderung medizinischer und biologischer Forschung;Novartis Pharmaceuticals;University of Erlangen-Nürnberg, Department of BiologyRecruiting18 Years55 YearsAll24Phase 2Switzerland
2EUCTR2015-001327-23-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
3EUCTR2013-001371-20-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
4EUCTR2013-001371-20-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
100Phase 4United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Tunisia;Netherlands;Germany;China;Korea, Republic of
5EUCTR2013-001371-20-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 LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United 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
6EUCTR2013-001371-20-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 LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United 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
7EUCTR2013-001371-20-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;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
8EUCTR2011-000831-10-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
9EUCTR2011-000831-10-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
10EUCTR2011-000831-10-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
11EUCTR2011-000831-10-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
12EUCTR2011-000831-10-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
13EUCTR2011-000831-10-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
14EUCTR2011-002184-17-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
15EUCTR2011-002184-17-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
16EUCTR2011-002184-17-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
17EUCTR2011-002184-17-GB
(EUCTR)
02/03/201217/01/2012Study 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). - 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: E
Glaxosmithkline Research and Development LtdNULLNot Recruiting Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany
18EUCTR2011-002184-17-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
Glaxosmithkline, S.A.NULLNot RecruitingFemale: yes
Male: yes
75Phase 3United States;Hong Kong;Taiwan;Spain;Thailand;Chile;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany
19EUCTR2011-002184-17-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
20NCT01416311
(ClinicalTrials.gov)
December 21, 20109/6/2011Drug Use Investigation for REVOLADE (ITP)Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)Purpura, Thrombocytopaenic, IdiopathicDrug: EltrombopagNovartis PharmaceuticalsNULLCompletedN/AN/AAll5797NULL
21EUCTR2009-010421-39-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
22EUCTR2009-010421-39-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
23EUCTR2009-010421-39-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
24EUCTR2009-010421-39-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
25EUCTR2006-000471-14-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
26EUCTR2006-000471-14-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
27EUCTR2006-002946-13-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