63. 特発性血小板減少性紫斑病
[臨床試験数:311,薬物数:185(DrugBank:39),標的遺伝子数:43,標的パスウェイ数:132

Searched query = "Idiopathic thrombocytopenic purpura", "Primary immune thrombocytopenia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
38 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04214951
(ClinicalTrials.gov)
January 1, 202028/12/2019A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune ThrombocytopeniaA Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune ThrombocytopeniaCorticosteroid-resistant or Relapsed ITPDrug: Eltrombopag;Drug: Recombinant human thrombopoietin (rh-TPO)Peking University People's HospitalNULLActive, not recruiting18 Years75 YearsAll100China
2ChiCTR1900027735
2020-01-012019-11-24Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP)Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP) Adult newly diagnosed immune thrombocytopeniaStudy group:Dexamethasone 40mg/d×4d, recombinant human thrombopoietin (rhTPO) 300U/Kg subcutaneous injection, once/d×14d, if PLT>100×109/L or PLT increase =50×109/L during treatment period RhTPO drug was discontinued; rhTPO and dexamethasone were replaced with prednisone 0.5mg~1mg/kg once a day, 0.2mg/kg per week, and the drug was stopped wit;Control group:Dexamethasone 40mg/d×4d, if the PLT>100×10^9/L or PLT increase =50×10^9/L during the treatment period, dexamethasone was replaced with prednisone 0.5mg~ 1mg/kg orally every day, reduce 0.2mg/kg per week, and quickly reduce the dose within 6~8 weeks.;Department of Hematology, Anhui Provincial HospitalNULLPending1880BothStudy group:30;Control group:30;Phase 4China
3NCT04089267
(ClinicalTrials.gov)
December 201610/9/2019Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)Multicenter, Randomized, Open, Parallel Controlled Trials Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)ITPDrug: TPOShenyang Sunshine Pharmaceutical Co., LTD.NULLCompleted18 YearsN/AAll288Phase 4China
4NCT02298075
(ClinicalTrials.gov)
April 201617/11/2014Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune ThrombocytopeniaResponse Rate and Response Duration After Discontinuation of Treatment With Thrombopoietin Receptor Agonists in Patients Affected by Primary Immune Thrombocytopenia (pITP): Retrospective StudyImmune ThrombocytopeniaDrug: Eltrombopag;Drug: RomiplostinGruppo Italiano Malattie EMatologiche dell'AdultoNULLUnknown status18 YearsN/AAll100Italy
5NCT02760251
(ClinicalTrials.gov)
April 201615/4/2016Immunomodulation With Romiplostim in Young Adults With ITPThrombopoietin-receptor Agonist-immunomodulation in Young Adult Primary Immune Thrombocytopenia (ITP): A Multi-center Open Label Trial With RomiplostimImmune ThrombocytopeniaDrug: romiplostimUniversity Hospital, Basel, SwitzerlandUniversity Children's Hospital BaselCompleted18 Years45 YearsAll15Phase 4Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02139501
(ClinicalTrials.gov)
May 201413/5/2014An Investigation of rhTPO With Different Frequencies in the Management of ITPA Randomized Study to Evaluate the Efficacy and Safety of Different Doses and Frequencies of Recombinant Human Thrombopoietin (rhTPO) in the Management of Primary Immune Thrombocytopenia (ITP)Immune ThrombocytopeniaDrug: Recombinant Human Thrombopoietin (rhTPO)Shandong UniversityThe First Affiliated Hospital of Dalian Medical University;Shandong Provincial HospitalCompleted18 Years60 YearsBoth48Phase 3China
7NCT01734057
(ClinicalTrials.gov)
July 201221/11/2012Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)Purpura;Idiopathic Thrombocytopenic PurpuraDrug: recombinant human thrombopoietin (rhTPO); rituximab;Drug: DexamethasoneShandong UniversityThe Affiliated Hospital of the Chinese Academy of Military Medical Sciences;Anhui Medical University;The First Affiliated Hospital of Dalian Medical University;Shandong Provincial Hospital;Shenzhen Second People's Hospital;China Medical University, China;Zhejiang Provincial Hospital of TCMWithdrawn18 Years75 YearsBoth0Phase 3China
8NCT01734044
(ClinicalTrials.gov)
July 201221/11/2012rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITPA Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)Purpura;Idiopathic Thrombocytopenic PurpuraDrug: recombinant human thrombopoietin (rhTPO); dexamethasone;Drug: DexamethasoneShandong UniversityThe Affiliated Hospital of the Chinese Academy of Military Medical Sciences;Anhui Medical University;The First Affiliated Hospital of Dalian Medical University;Shandong Provincial Hospital;Shenzhen Second People's Hospital;China Medical University, China;Zhejiang Provincial Hospital of TCMCompleted18 Years75 YearsBoth158Phase 3China
9EUCTR2011-002184-17-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
10EUCTR2011-002184-17-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
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-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
12EUCTR2011-002184-17-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]
Glaxosmithkline Research and Development LtdNULLNot Recruiting Female: yes
Male: yes
75Phase 3United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany
13NCT01520909
(ClinicalTrials.gov)
March 201221/12/2011Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (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 ITPIdiopathic Thrombocytopenic PurpuraDrug: Eltrombopag;Drug: PlaceboGlaxoSmithKlineNULLCompleted1 Year17 YearsAll92Phase 3United States;Argentina;Czech Republic;Germany;Hong Kong;Israel;Italy;Poland;Russian Federation;Spain;Taiwan;Thailand;United Kingdom;Chile
14EUCTR2011-002184-17-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
15EUCTR2011-002184-17-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01525836
(ClinicalTrials.gov)
May 201131/1/2012rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITPRecombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP.Purpura;Idiopathic Thrombocytopenic PurpuraDrug: rituximab; recombinant human thrombopoietin (rhTPO);Drug: RituximabShandong UniversityThe Affiliated Hospital of the Chinese Academy of Military Medical Sciences;The First Affiliated Hospital of Anhui Medical University;The First Affiliated Hospital of Dalian Medical University;Shandong Provincial Hospital;Shenzhen Second People's Hospital;First Hospital of China Medical UniversityCompleted18 Years72 YearsBoth123Phase 3China
17EUCTR2006-002946-13-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
18NCT01805648
(ClinicalTrials.gov)
February 201122/2/2013Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITPA Multicenter, Single-Arm, Open Label Study Evaluating the Efficacy and Safety of Maintenance Treatment With Recombinant Human Thrombopoietin in Thrombocytopenic Subjects With Immune ThrombocytopeniaThrombocytopenia;Immune Thrombocytopenia;Idiopathic Thrombocytopenic PurpuraDrug: rhTPOPeking Union Medical CollegeShenyang Sunshine Pharmaceutical Co., LTD.Recruiting14 Years70 YearsBoth120Phase 3China
19NCT00908037
(ClinicalTrials.gov)
September 30, 200921/5/2009Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP)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 ITP.Purpura, Thrombocytopaenic, IdiopathicDrug: eltrombopag;Drug: PlaceboGlaxoSmithKlineNULLCompleted1 Year17 YearsAll82Phase 2United States;Canada;France;Netherlands;Spain;United Kingdom
20EUCTR2006-002946-13-GB
(EUCTR)
18/09/200906/07/2009 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 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: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
70Phase 2France;Spain;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2006-002946-13-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
22EUCTR2006-002946-13-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
23NCT01506414
(ClinicalTrials.gov)
June 200916/11/2011Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP)A Multicentre Investigation of Recombinant Human Thrombopoietin (Rh-TPO) Combine With Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)Purpura;Idiopathic Thrombocytopenic PurpuraDrug: rhTPO in combination with RituximabMing HouPeking Union Medical College Hospital;Chinese Academy of Medical Sciences;First Affiliated Hospital, Sun Yat-Sen University;West China Hospital;Shandong Provincial Hospital;Wuhan Union Hospital, China;Zhejiang UniversityCompleted16 Years75 YearsBoth91Phase 3China
24NCT00888901
(ClinicalTrials.gov)
May 200927/4/2009Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With EltrombopagAssessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.Idiopathic Thrombocytopenic PurpuraDrug: eltrombopag;Drug: corticosteroids (Aprednislon)Ingrid Pabinger, MDGlaxoSmithKlineCompleted18 Years90 YearsBoth30Phase 4Austria
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
26EUCTR2006-000470-78-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
27EUCTR2006-000470-78-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
28EUCTR2006-000470-78-IT
(EUCTR)
17/01/200705/02/2007RAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with EltrombopagRAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with Eltrombopag Idiopathic thrombocytopenic purpura ITP
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB-497115-GR
Product Name: Eltrombopag
Product Code: SB-497115-GR
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
29EUCTR2006-000470-78-SK
(EUCTR)
17/01/200730/11/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
30EUCTR2006-000470-78-FR
(EUCTR)
22/12/200616/11/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
189Phase 3France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2006-000470-78-FI
(EUCTR)
12/12/200625/10/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
32EUCTR2006-000470-78-DK
(EUCTR)
29/11/200610/11/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3France;Czech Republic;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
33EUCTR2006-000470-78-GB
(EUCTR)
22/11/200608/05/2008A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
189Phase 3France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;Italy;United Kingdom
34EUCTR2006-000470-78-ES
(EUCTR)
22/11/200613/04/2012A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP).A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
189Phase 3Germany;France;Hong Kong;Austria;Brazil;Czech Republic;Tunisia;Canada;New Zealand;Peru;Greece;United States;Poland;Netherlands;Italy;Vietnam;Finland;India;Russian Federation;Slovakia;United Kingdom;Denmark;Taiwan;Estonia;China;Spain
35EUCTR2006-000470-78-AT
(EUCTR)
22/11/200620/11/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT00370331
(ClinicalTrials.gov)
November 200629/8/2006RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With EltrombopagA Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy, Safety and Tolerability of Eltrombopag Olamine (SB-497115-GR), a Thrombopoietin Receptor Agonist, Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP.Purpura, Thrombocytopaenic, IdiopathicDrug: eltrombopag;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 YearsN/AAll197Phase 3United States;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;India;Italy;Netherlands;New Zealand;Peru;Poland;Russian Federation;Slovakia;Spain;Taiwan;Tunisia;Ukraine;United Kingdom;Vietnam;Estonia
37EUCTR2006-000470-78-NL
(EUCTR)
30/10/200601/09/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
38EUCTR2006-002946-13-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