Eltrombopag    (DrugBank: Eltrombopag)

5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
60再生不良性貧血27
63特発性血小板減少性紫斑病76
65原発性免疫不全症候群2
284ダイアモンド・ブラックファン貧血1
285ファンコニ貧血1

60. 再生不良性貧血 [臨床試験数:218,薬物数:362(DrugBank:81),標的遺伝子数:39,標的パスウェイ数:155
Searched query = "Aplastic anemia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
27 / 218 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1NCT04328727
(ClinicalTrials.gov)
November 4, 20209/3/2020Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic AnemiaA Non-randomized, Open Label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin (r-ATG) and Cyclosporine A (CsA) in East-Asian Patients With Treatment Naive Severe Aplastic Anemia (REACTS)Severe Aplastic Anemia (SAA)Drug: eltrombopag;Drug: rabbit anti-thymocyte globulin (r-ATG);Drug: cyclosporine A (CsA)Novartis PharmaceuticalsNULLRecruiting6 YearsN/AAll36Phase 2China;Japan
2NCT04403321
(ClinicalTrials.gov)
July 1, 202021/5/2020Efficacy and Safety of Eltrombopag + Tacrolimus/Cyclosporin A in Chinese Refractory or Relapsed Aplastic Anemia PatientsEfficacy and Safety of Eltrombopag + Tacrolimus/Cyclosporin A in Chinese Refractory or Relapsed Aplastic Anemia PatientsAplastic Anemia;Drug EffectDrug: Tacrolimus;Drug: Placebo (for Tacrolimus);Drug: Cyclosporin APeking Union Medical College HospitalNULLNot yet recruiting16 Years80 YearsAll60Phase 2China
3NCT04304820
(ClinicalTrials.gov)
May 7, 202010/3/2020Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)Severe Aplastic AnemiaDrug: Eltrombopag;Drug: Cyclosporine;Drug: Horse-Anti-thymocyte-GlobulinNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting3 YearsN/AAll39Phase 2United States
4NCT03988608
(ClinicalTrials.gov)
December 9, 201913/6/2019Study to Assess the Safety and Efficacy of Eltrombopag in Chinese Refractory or Relapsed Severe Aplastic Anemia (SAA) Subjects.A Non-randomized, Open-label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Chinese Subjects With Refractory or Relapsed Severe Aplastic AnemiaAplastic AnemiaDrug: Eltrombopag 25 mgNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll20Phase 2China
5JPRN-jRCTs071190032
26/11/201921/10/2019W-JHS AA02Investigation on the effectiveness of rabbit ATG + cyclosporine + eltrombopag therapy for patients with aplastic anemia - W-JHS AA02 aplastic anemia1. The administration of rATG; 2.5 mg/kg, iv. daily, day 1 - day 5 + CsA; 5 mg/kg, po. bid (before breakfast and before dinner) +adrenalcorticosteroid (the dose is mentioned after) is started. CsA used is Neoral or generic drug emulsified in the same way with Neoral. A blood level of CsA is measured and the dose which CsA blood level 2 hours after oral administration (C2) reachs 600 - 900 ng/mL is adjusted. The investigator shall reduce the dose of CsA by 25% on this occasion when blood trough level (C0) just before the administration is beyond 250 ng/mL because renal function disorder may occur (2). When serum creatinine level also becomes higher than 150% of baselines, the 25% dose reduction of CsA shall be performed. If C2 did not reach to 600 ng/mL, then dose of CsA is appropriately increased.
2. EPAG; 75 mg, po. daily (before sleep, requires to pass more than at least 2 hours after dinner) is started from day 6.
3. The dose of steroid is as follows:
Day 1 - day 5: methylprednisolone 2 mg/kg/day
Day 6: Methylprednisolone 1 mg/kg/day
Day 8, 10, 12, 14, 16, 18, 20: prednisolone 0.5 mg/kg/day
Discontinuation after day 21
4. The administration of CsA and EPAG is continued for 26 weeks. When it passed 26 weeks, further treatment mentioned above is entrusted to the investigator in each medical institution after 27 weeks if patients reached Camitta criteria CR or PR. However, the administration is continued for 52 weeks even if the dose of CsA is reduced. The treatment after 53 weeks is not specified. If patients did not reach CR or PR at 26 weeks, treatment after 27 weeks is entrusted to the investigator in each medical institution (it is not specified in this study).
Nakao ShinjiNULLRecruiting>= 18age old< 80age oldBoth60Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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Inclusion_
agemin
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agemax
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size
PhaseCountries
6EUCTR2015-003166-91-GB
(EUCTR)
22/05/201905/07/2017A phase II dose escalation study: use of eltrombopag in pediatric patientswith severe aplastic anemia or recurrent aplastic anemiaA phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA)
MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom
7EUCTR2015-003166-91-NL
(EUCTR)
14/11/201808/08/2017 A phase II dose escalation study: use of eltrombopag in pediatric patients with severe aplastic anemia or recurrent aplastic anemiaA phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA)
MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Hong Kong;Russian Federation;Netherlands;United Kingdom
8NCT03243656
(ClinicalTrials.gov)
December 20, 20172/8/2017Eltrombopag in Children With Idiopathic Aplastic AnemiaRandomized Clinical Trial of the Use of Eltrombopag in Children With Idiopathic Aplastic AnemiaEltrombopagDrug: EltrombopagAssiut UniversityNULLRecruiting1 Year18 YearsAll20Phase 4Egypt
9EUCTR2015-003166-91-PT
(EUCTR)
15/12/201713/07/2017A phase II dose-escalation study characterizing the PK of eltrombopag in pediatric patients with previously untreated or relapsed severe aplastic anemia or recurrent aplastic anemia.A phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA)
MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom
10NCT03025698
(ClinicalTrials.gov)
September 30, 201712/1/2017A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic AnemiaA Phase II, Open-label, Non-controlled, Intra-patient Dose-escalation Study to Characterize the Pharmacokinetics After Oral Administration of Eltrombopag in Pediatric Patients With Refractory, Relapsed or Treatment Naive Severe Aplastic Anemia or Recurrent Aplastic AnemiaAplastic AnemiaDrug: Eltrombopag;Drug: hATG;Drug: CsANovartis PharmaceuticalsNULLRecruiting1 Year18 YearsAll60Phase 2United States;Hong Kong;Netherlands;Portugal;Russian Federation;Thailand;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemin
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agemax
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size
PhaseCountries
11EUCTR2016-002814-29-HU
(EUCTR)
07/09/201705/07/2017SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months.SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR First-line severe aplastic anaemia
MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Hong Kong;Hungary;Mexico;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India
12EUCTR2016-002814-29-NL
(EUCTR)
21/07/201729/03/2017SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia with follow-up up to 24-months.SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR First-line severe aplastic anaemia
MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Hungary;Hong Kong;Mexico;Thailand;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India
13NCT02998645
(ClinicalTrials.gov)
May 11, 20174/11/2016Eltrombopag Combined With Cyclosporine as First Line Therapy in Patients With Severe Acquired Aplastic AnemiaSOAR, Interventional Phase II Single-arm Study to Assess Efficacy and Safety of Eltrombopag Combined With Cyclosporine as First Line Therapy in Adult Patients With Severe Acquired Aplastic AnemiaSevere Aplastic AnemiaDrug: eltrombopag;Drug: CyclosporineNovartis PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll54Phase 2Brazil;Hong Kong;India;Italy;Korea, Republic of;Mexico;Spain;Thailand;Turkey;Hungary;Netherlands
14EUCTR2016-002814-29-ES
(EUCTR)
21/03/201716/12/2016SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months.SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR First-line severe aplastic anaemia
MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Novartis Farmacéutica, S.ANULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noQatar;Hong Kong;Spain;Turkey;Italy;India;France;Hungary;Mexico;Canada;Brazil;Netherlands;Korea, Republic of
15NCT03413306
(ClinicalTrials.gov)
December 10, 201622/12/2017Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AAA Phase II Multicenter Randomized Study of Eltrombopag Combined With Cyclosporine and hATG Versus hATG and CsA as First Line Treatment in Pediatric Patients With Severe Acquired Aplastic AnemiaAcquired Aplastic AnemiaDrug: Eltrombopag;Drug: IST (ATG + CsA)Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyNULLRecruiting2 Years18 YearsAll100Phase 3Russian Federation
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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Inclusion_
agemin
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agemax
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PhaseCountries
16EUCTR2014-000363-40-NL
(EUCTR)
07/01/201601/09/2015A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function.A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia.
MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
INN or Proposed INN: ELTROMBOPAG
European Society for Blood and Marrow TransplantationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Spain;Netherlands
17EUCTR2014-000363-40-ES
(EUCTR)
26/10/201507/09/2015A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function.A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia.
MedDRA version: 18.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Revolade
INN or Proposed INN: ELTROMBOPAG
European Society for Blood and Marrow TransplantationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Spain
18NCT02099747
(ClinicalTrials.gov)
July 20156/3/2014hATG+CsA vs hATG+CsA+Eltrombopag for SAAA Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients.Severe Aplastic AnemiaDrug: hATG;Drug: CsA;Drug: EltrombopagEuropean Group for Blood and Marrow TransplantationNovartis;PfizerActive, not recruiting15 YearsN/AAll202Phase 3France;Italy;Netherlands;Spain;Switzerland;United Kingdom;Germany
19NCT02404025
(ClinicalTrials.gov)
May 12, 201526/2/2015Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) SubjectsA Non-randomized, Phase II Study of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A (ATG/CsA) in Subjects With Moderate or More Severe Aplastic Anemia Who Have Not Received Prior ATG/Anti-lymphocyte Globulin (ALG)-Based Immunosuppressive TherapyAplastic AnemiaDrug: Eltrombopag;Drug: Rabbit ATG;Drug: CsANovartis PharmaceuticalsNULLCompleted18 Years75 YearsAll10Phase 2Japan
20NCT02773225
(ClinicalTrials.gov)
January 27, 201529/2/2016Efficacy and Safety of Eltrombopag + CSA in Patients With Moderate Aplastic Anemia (EMAA)Efficacy and Safety of Thrombopoetin-Receptor Agonist Eltrombopag in in Combination With Ciclosporin A in Moderate Aplastic Anemia (EMAA): Prospective Randomized Multicenter StudyAnemia, AplasticDrug: Eltrombopag;Drug: Placebo (for Eltrombopag)B. HöchsmannNULLRecruiting18 YearsN/AAll116Phase 2/Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
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gender
Target_
size
PhaseCountries
21EUCTR2014-000174-19-DE
(EUCTR)
27/01/201501/09/2014Efficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopag with Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin AEfficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopagwith Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A - EMAA Moderate Aplastic Anemia (MAA);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Trade Name: Revolade 75 mg
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: Eltrombopag
Other descriptive name: ELTROMBOPAG OLAMINE
Universitätsklinikum UlmNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2;Phase 3France;Netherlands;Germany;Italy;Switzerland
22NCT02148133
(ClinicalTrials.gov)
July 23, 201422/5/2014A Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic AnemiaA Non-randomized, Open-label, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic AnemiaCytopaeniaDrug: Eltrombopag 12.5 mg;Drug: Eltrombopag 25 mgNovartis PharmaceuticalsNULLCompleted18 Years79 YearsAll21Phase 2Japan
23NCT01891994
(ClinicalTrials.gov)
June 28, 201328/6/2013Extended Dosing With Eltrombopag for Severe Aplastic AnemiaExtended Dosing With Eltrombopag in Refractory Severe Aplastic AnemiaSevere Aplastic Anemia (SAA)Drug: EltrombopagNational Heart, Lung, and Blood Institute (NHLBI)NULLActive, not recruiting2 Years100 YearsAll40Phase 2United States
24NCT01703169
(ClinicalTrials.gov)
November 201227/9/2012Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic AnemiaEfficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic AnemiaSevere Aplastic Anemia;Very Severe Aplastic Anemia;Moderate Aplastic AnemiaDrug: EltrombopagUniversity of UtahNovartisCompleted18 YearsN/AAll13Phase 2United States
25NCT01623167
(ClinicalTrials.gov)
July 2, 201214/6/2012Eltrombopag With Standard Immunosuppression for Severe Aplastic AnemiaEltrombopag Added to Standard Immunosuppression in Treatment-Naive Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: Cohort 1: hATG, CsA, EPAG Day 14 to Month 6;Drug: Cohort 2: hATG, CsA, EPAG Day 14 to Month 3;Drug: Cohort 3: hATG, CsA (dose reduced), EPAG day 1 to month 6;Drug: Extension CohortNational Heart, Lung, and Blood Institute (NHLBI)NovartisRecruiting2 Years95 YearsAll207Phase 1/Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
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Inclusion_
gender
Target_
size
PhaseCountries
26NCT01328587
(ClinicalTrials.gov)
April 1, 20111/4/2011Eltrombopag for Moderate Aplastic AnemiaA Pilot Study of a Thrombopoietin-Receptor Agonist (TPO-R Agonist), Eltrombopag, in Moderate Aplastic Anemia PatientsModerate Aplastic Anemia;Unilineage Bone Marrow Failure DisordersDrug: EltrombopagNational Heart, Lung, and Blood Institute (NHLBI)NULLActive, not recruiting2 Years100 YearsAll34Phase 2United States
27NCT00922883
(ClinicalTrials.gov)
May 29, 200916/6/2009A Pilot Study of the Thrombopoietin-Receptor Agonist Eltrombopag in Refractory Aplastic Anemia PatientsA Pilot Study of a Thrombopoietin-Receptor Agonist (TPO-R Agonist), Eltrombopag, in Aplastic Anemia Patients With Immunosuppressive-Therapy Refractory ThrombocytopeniaAnemia, Aplastic;Anemia, Hypoplastic;ThrombocytopeniaDrug: EltrombopagNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted12 YearsN/AAll43Phase 2United States

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.
76 / 311 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04518475
(ClinicalTrials.gov)
August 10, 202012/8/2020Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in AdultsA Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP PatientsPrimary Immune Thrombocytopenia (ITP)Drug: eltrombopag combining rituximab;Drug: eltrombopagInstitute of Hematology & Blood Diseases HospitalThe Second Affiliated Hospital of Kunming Medical University;Henan Cancer Hospital;Tianjin Medical University Second Hospital;The First Affiliated Hospital of Xiamen University;Nantong UniversityRecruiting18 Years60 YearsAll224Phase 4China
2ChiCTR2000030603
2020-05-012020-03-08Clinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopeniaClinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopenia Primary Immune ThrombocytopeniaThe short -course glucocorticoid group:treat with glucocorticoid;The eltrombopag group:treat with eltrombopag;The rituximab group:treat with rituximab;Splenectomy group:treat with splenectomy;The azathioprine group:treat with azathioprine;The cyclosporine group:treat with cyclosporine;The Second Affiliated Hospital of Kunming Medical UniversityNULLPending1875BothThe short -course glucocorticoid group:65;The eltrombopag group:65;The rituximab group:65;Splenectomy group:65;The azathioprine group:65;The cyclosporine group:65;Phase 4China
3NCT04214951
(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
4NCT03771378
(ClinicalTrials.gov)
January 16, 20197/12/2018Efficacy and Safety of rhTPO and Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP)Efficacy and Safety of rhTPO and Eltrombopag in the Treatment of Chinese Adults With Primary Immune Thrombocytopenia (ITP):a Multicenter, Double-blind, Randomized, Controlled TrialPrimary Immune ThrombocytopeniaDrug: rhTPO;Drug: eltrombopagWuhan Union Hospital, ChinaThe First Affiliated Hospital of Nanchang University;The Third Xiangya Hospital of Central South University;The First People's Hospital of Yuhang District;Xiangyang Central HospitalRecruiting18 Years75 YearsAll96Phase 4China
5NCT03412188
(ClinicalTrials.gov)
August 1, 201820/1/2018The Effect of Eltrombopag on the Expression of Platelet Collagen Receptor GPVI in Pediatric ITP.Evaluation of the Effect of Eltrombopag on the Expression of Platelet Collagen Receptor Glycoprotein VI (GPVI) in Pediatric Patients With Chronic and Persistent Immune Thrombocytopenia.Idiopathic Thrombocytopenic PurpuraDrug: Eltrombopag;Drug: conventionalNayera Hazaa ElsherifNULLRecruiting1 Year18 YearsAll40N/AEgypt
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03830749
(ClinicalTrials.gov)
July 1, 20181/2/2019Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic PurpuraA Pilot Study to Evaluate the Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone as First Line Therapy for Subjects With Idiopathic Thrombocytopenic Purpura (ITP)Immune ThrombocytopeniaDrug: EltrombopagHumanity & Health Medical Group LimitedNULLRecruiting18 YearsN/AAll60Phase 2Hong Kong
7NCT02298075
(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
8EUCTR2015-001327-23-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
9NCT02402998
(ClinicalTrials.gov)
June 201522/3/2015Eltrombopag in Second Line Adult Primary Immune ThrombosytopeniaEltrombopag 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 StudyPrimacy Immune ThrombocytopeniaDrug: EltrombopagGruppo Italiano Malattie EMatologiche dell'AdultoNULLUnknown status18 YearsN/AAll52Phase 2Italy
10ChiCTR1900021211
2015-04-012019-02-01A pilot study for evaluation of the safety and efficacy of eltrombopag plus pulsed dexamethasone as first line therapy for subjects with idiopathic thrombocytopenic purpura (ITP)A pilot study for evaluation of the safety and efficacy of eltrombopag plus pulsed dexamethasone as first line therapy for subjects with idiopathic thrombocytopenic purpura (ITP) immune thrombocytopenia (ITP)1:eltrombopag 25-75mg daily for 3 months plus pulsed dexamethasone, 40mg daily for 4 days repeated every 4 weeks for 1-3 courses;University Hospital, MacauNULLRecruiting18100Both1:60;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2013-001371-20-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
12EUCTR2013-001371-20-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
13EUCTR2013-001371-20-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
14EUCTR2013-001371-20-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
15EUCTR2013-001371-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2013-001371-20-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
17EUCTR2011-000831-10-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
18EUCTR2011-000831-10-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
19EUCTR2011-000831-10-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
20EUCTR2011-000831-10-AT
(EUCTR)
05/06/201216/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2011-000831-10-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
22EUCTR2011-000831-10-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
23EUCTR2011-002184-17-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
24EUCTR2011-002184-17-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
25NCT01433978
(ClinicalTrials.gov)
March 26, 201213/9/2011A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)Idiopathic Thrombocytopenic PurpuraDrug: Eltrombopag;Drug: Avatrombopag;Drug: Standard of careEisai Inc.NULLTerminated18 Years99 YearsAll24Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-002184-17-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
27EUCTR2011-002184-17-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
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
28NCT01520909
(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
29EUCTR2011-002184-17-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
30EUCTR2011-002184-17-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
31EUCTR2006-002946-13-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
32NCT01416311
(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
33EUCTR2009-010421-39-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
34EUCTR2009-010421-39-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
35EUCTR2009-010421-39-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
36EUCTR2009-010421-39-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
37NCT00908037
(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
38EUCTR2006-002946-13-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
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Netherlands;United Kingdom
39EUCTR2006-002946-13-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
40EUCTR2006-002946-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT00888901
(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
42NCT00902018
(ClinicalTrials.gov)
January 20098/5/2009Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP)The Effect of Eltrombopag on Platelet Survival: the Role of the B-cell L Extra Large (BcL-xL) PathwayImmune ThrombocytopeniaDrug: Eltrombopag;Drug: Romiplostim;Other: healthy controlsWeill Medical College of Cornell UniversityGlaxoSmithKlineCompleted18 YearsN/AAll20Phase 2United States
43EUCTR2006-000471-14-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
44NCT00828750
(ClinicalTrials.gov)
May 200822/1/2009Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)-An Extension Study of Eltrombopag in Subjects, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study TRA108109 (NCT00540423)-Idiopathic Thrombocytopenic Purpura;Purpura, Thrombocytopenic, IdiopathicDrug: Eltrombopag oral tabletsGlaxoSmithKlineNULLCompleted20 YearsN/AAll19Phase 3Japan
45EUCTR2006-000471-14-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
46EUCTR2006-000471-14-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
47EUCTR2006-000471-14-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
48EUCTR2006-000471-14-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
49EUCTR2006-000471-14-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
50EUCTR2006-000470-78-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
51EUCTR2006-000471-14-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
52EUCTR2006-002943-10-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
53EUCTR2006-002943-10-GB
(EUCTR)
13/04/200726/02/2007 REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Germany;United Kingdom
54EUCTR2006-000470-78-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
55EUCTR2006-002943-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT00424177
(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
57EUCTR2006-000471-14-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
58EUCTR2006-000470-78-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
59EUCTR2006-000471-14-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
60EUCTR2006-000470-78-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2006-000470-78-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
62EUCTR2006-000470-78-FR
(EUCTR)
22/12/200616/11/2006A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
189 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
63EUCTR2006-000470-78-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
64EUCTR2006-000470-78-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
65EUCTR2006-000470-78-GB
(EUCTR)
22/11/200608/05/2008A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
189 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2006-000470-78-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
67EUCTR2006-000470-78-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
68NCT00370331
(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
69EUCTR2006-000470-78-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
70EUCTR2006-000471-14-GB
(EUCTR)
23/10/200603/06/2007EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND Immune Thrombocytopenic Purpura (ITP)
MedDRA version: 12.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSlovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2006-000471-14-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
72EUCTR2006-000471-14-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
73EUCTR2006-000471-14-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
74EUCTR2006-000471-14-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
75NCT00351468
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2006-002946-13-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

65. 原発性免疫不全症候群 [臨床試験数:413,薬物数:581(DrugBank:97),標的遺伝子数:68,標的パスウェイ数:202
Searched query = "Primary immunodeficiency", "X-SCID", "Reticular dysgenesis", "Adenosine deaminase deficiency", "Omenn syndrome", "Purine nucleoside phosphorylase deficiency", "CD8 deficiency", "ZAP-70 deficiency", "MHC class I deficiency", "MHC class II deficiency", "Combined immunodeficiency", "Wiskott-Aldrich syndrome", "Telangiectasia ataxia", "Nijmegen breakage syndrome", "Bloom syndrome", "Immunodeficiency, centromere region instability, facial anomalies syndrome", "ICF syndrome", "PMS2 deficiency", "Radiosensitivity, immunodeficiency, dysmorphic features, and learning difficulties syndrome", "RIDDLE syndrome", "Schimke syndrome", "Netherton syndrome", "Thymic hypoplasia", "DiGeorge syndrome", "22q11.2 deletion syndrome", "Hyper-IgE syndrome", "Hepatic venoocclusive immunodeficiency", "Immunodeficiency with central hepatic vein atresia", "Dyskeratosis congenita", "X-linked agammaglobulinaemia", "Common variable immunodeficiency", "Hyper-IgM syndrome", "Isolated IgG subclass deficiency", "Selective IgA deficiency", "Specific antibody production deficiency", "Infant transient hypogammaglobulinemia", "Chédiak-Higashi syndrome", "Chediak-Higashi syndrome", "X-linked lymphoproliferative syndrome", "SAP deficiency", "SH2D1A/SLAM-associated protein deficiency", "XIAP deficiency", "X-linked inhibitor of apoptosis deficiency", "Autoimmune lymphoproliferative syndrome", "ALPS", "Familial hemophagocytic syndrome", "Perforin deficiency", "Munc13-4 deficiency", "Syntaxin 11 deficiency", "Munc18-2 deficiency", "Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy", "APECED", "Immune dysregulation, polyendocrinopathy, enteropathy, X-linked syndrome", "IPEX syndrome", "CD25 deficiency", "ITCH deficiency", "Primary phagocytic dysfunction", "Severe congenital neutropenia", "Cyclic neutropenia", "Hermanskyi-Pudlak syndrome type 2", "Hermanskyi-Pudlak syndrome 2", "Griscelli syndrome type 2", "Griscelli syndrome 2", "p14 deficiency", "Warts, hypogammaglobulinemia, infections, myelokathexis syndrome", "WHIM syndrome", "Glycogen storage disease type Ib", "Leukocyte adhesion deficiency", "Shwachman-Diamond syndrome", "Chronic granulomatous disease", "Myeloperoxidase deficiency", "Mendelian susceptibility to mycobacterial disease", "MSMD", "Anhidrotic ectodermal dysplasia with immunodeficiency", "EDA-ID", "Interleukin-1 receptor-associated kinase-4 deficiency", "IRAK4 deficiency", "IMyD88 deficiency", "Chronic mucocutaneous candidiasis", "Epidermodysplasia verruciformis", "Herpes simplex encephalitis", "Caspase recruitment domain family member 9 deficiency", "CARD9 deficiency", "Trypanosomiasis", "Congenital complement deficiency", "C1q deficiency", "CC1r deficiency", "CC1s deficiency", "CC2 deficiency", "CC3 deficiency", "CC4 deficiency", "CC5 deficiency", "CC6 deficiency", "CC7 deficiency", "CC8 deficiency", "CC9 deficiency", "Factor D deficiency", "Properdin deficiency", "Factor I deficiency", "Factor H deficiency", "MASP1 deficiency", "3MC syndrome", "Mannose-binding protein-associated serine protease 2 deficiency", "MASP2 deficiency", "FCN3", "Hereditary angioedema type 1", "Hereditary angioedema type I", "C1 inhibitor deficiency type 1", "C1 inhibitor deficiency type I", "Hereditary angioedema type 2", "Hereditary angioedema type II", "C1 inhibitor deficiency type 2", "C1 inhibitor deficiency type II", "Hereditary angioedema type 3", "Hereditary angioedema type III", "C1 inhibitor deficiency type 3", "C1 inhibitor deficiency type III"
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.
2 / 413 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04371939
(ClinicalTrials.gov)
November 5, 201929/4/2020Efficacy and Safety of Romiplostim Versus Eltrombopag in the Treatment of Thrombocytopenia in Patients With Wiskott-Aldrich SyndromeRandomized, Two-arm Single-center Phase II Clinical Trial Comparing the Efficacy and Safety of Romiplostim Versus Eltrombopag in the Treatment of Thrombocytopenia in Patients With Wiskott-Aldrich SyndromeWiskott-Aldrich SyndromeDrug: Romiplostim;Drug: EltrombopagFederal Research Institute of Pediatric Hematology, Oncology and ImmunologyNULLRecruitingN/A18 YearsAll30Phase 2Russian Federation
2NCT00909363
(ClinicalTrials.gov)
June 200927/5/2009Thrombocytopenia and Bleeding in Wiskott-Aldrich Syndrome (WAS) PatientsEffects Of Eltrombopag On Thrombocytopenia, Platelet Function and Bleeding In Patients With Wiskott-Aldrich Syndrome/X-Linked Thrombocytopenia.Wiskott-Aldrich Syndrome;Thrombocytopenia;BleedingDrug: Promacta;Diagnostic Test: blood drawing in patients with WAS;Diagnostic Test: blood drawing in healthy controlsWeill Medical College of Cornell UniversityNovartis PharmaceuticalsTerminated3 Months80 YearsMale24Phase 2United States

284. ダイアモンド・ブラックファン貧血 [臨床試験数:37,薬物数:110(DrugBank:34),標的遺伝子数:22,標的パスウェイ数:121
Searched query = "Diamond-Blackfan anemia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 37 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04269889
(ClinicalTrials.gov)
December 1, 202013/2/2020Treatment of Refractory Diamond-Blackfan Anemia With EltrombopagTreatment of Refractory Diamond-Blackfan Anemia With EltrombopagAnemia, Diamond-BlackfanDrug: EltrombopagNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting2 YearsN/AAll25Phase 1/Phase 2United States

285. ファンコニ貧血 [臨床試験数:56,薬物数:111(DrugBank:31),標的遺伝子数:30,標的パスウェイ数:151
Searched query = "Fanconi anemia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 56 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03206086
(ClinicalTrials.gov)
November 2, 201830/6/2017Eltrombopag for People With Fanconi AnemiaEltrombopag for Patients With Fanconi AnemiaFanconi's AnemiaDrug: EltrombopagNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting2 YearsN/AAll25Phase 2United States