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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
27 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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Target_
size
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_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
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_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
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_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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
Inclusion_
agemax
Inclusion_
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
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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