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"
17 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04328727November 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
2NCT04304820May 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
3JPRN-UMIN0000304532017/12/2018/12/2017Efficacy of cyclosporine therapy in the treatment of non-severe aplastic anemiaEfficacy of cyclosporine therapy in the treatment of non-severe aplastic anemia - Aplastic anemia 01 study in West Japan Hematology Study Group (W-JHS AA01 study) aplastic anemia1.Start CsA (Neoral or generic drugs emulsified in the same way as Neoral) at a dose of 3.5 mg/kg, bid (before breakfast and before dinner).
2.Measure the blood concentration of cyclosporine at 2 hours (C2) after taking the drug and determine the minimum dose of cyclosporine that produces C2 >600 ng/mL. Continue the dose of cyclosporine for 8 weeks.
3.Continue the treatment for further 44 weeks (a total of 52 weeks) when patients meet the response criteria of HI-E or HI-P at the end of the 8 week treatment. Treatments after the 52 weeks are not specified. When patients do not meet the IWG response criteria 2006 at the end of 8 weeks, the treatment is terminated and treatments after 9 weeks are not specified.
Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center KyushuNULLRecruiting16years-oldNot applicableMale and Female33Not selectedJapan
4EUCTR2016-002814-29-HU07/09/201705/07/2017SOAR 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: 20.0Level: PTClassification code 10002967Term: Aplastic anaemiaSystem 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
5EUCTR2016-002814-29-NL21/07/201729/03/2017SOAR 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: 20.0Level: PTClassification code 10002967Term: Aplastic anaemiaSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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PhaseCountries
6NCT02998645May 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
7EUCTR2016-002814-29-ES21/03/201716/12/2016SOAR 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 Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noQatar;Hong Kong;Spain;Turkey;Italy;India;France;Hungary;Mexico;Canada;Brazil;Netherlands;Korea, Republic of
8NCT03413306December 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
9EUCTR2014-000363-40-NL07/01/201601/09/2015A 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: 19.0Level: PTClassification code 10002967Term: Aplastic anaemiaSystem 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
10EUCTR2014-000363-40-ES26/10/201507/09/2015A 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: 18.0Level: PTClassification code 10002967Term: Aplastic anaemiaSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
11NCT02462252October 201525/5/2015Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic SyndromeA Phase IIA, Open-label Study Designed to Evaluate Efficacy and Safety of BL-8040 Followed by Anti-Thymocyte Globulin (hATG), Cyclosporine and Methylprednisolone in Adult Subjects With Aplastic Anemia (AA) or Hypoplastic Myelodysplastic Syndrome (MDS)Aplastic Anemia;Hypoplastic Myelodysplastic SyndromeDrug: BL-8040;Drug: horse anti-thymocyte globulin (hATG);Drug: Methylprednisolone;Drug: CyclosporineBioLineRx, Ltd.NULLRecruiting18 YearsN/AAll25Phase 2United States
12NCT02099747July 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
13NCT01760096January 20131/1/2013Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)Paroxysmal Nocturnal Hemoglobinuria;Hemoglobinuria;Hemoglobinuria, Paroxysmal;Proteinuria;Urination Disorders;Thrombosis;Bone Marrow Failure;Aplastic Anemia,;Anemia, HemolyticDrug: Levamisole+cyclosporin A+Glucocorticoids;Drug: cyclosporin A+Glucocorticoids;Drug: GlucocorticoidsInstitute of Hematology & Blood Diseases HospitalNULLActive, not recruiting18 YearsN/ABoth50Phase 2China
14NCT01642979July 201214/7/2012Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal HemoglobinuriaPhase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal HemoglobinuriaParoxysmal Nocturnal Hemoglobinuria;Hemoglobinuria;Hemoglobinuria, Paroxysmal;Proteinuria;Urination Disorders;Thrombosis;Bone Marrow Failure;Aplastic Anemia,;Anemia, HemolyticDrug: Levamisole+cyclosporin A+Glucocorticoids;Drug: cyclosporin A+Glucocorticoids;Drug: GlucocorticoidsInstitute of Hematology & Blood Diseases HospitalNULLActive, not recruiting18 YearsN/ABoth120Phase 2China
15EUCTR2006-006577-25-SE25/07/200711/06/2007A prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantationA prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantation Graft versus host disease prophylaxis in patients receiving stem cell transplantation due to: chronic myeloid leukemia (CML) in 1st or 2nd chronic phase, acute myeloid leukemia (AML) in complete remission, acute lymphoblastic leukemia (ALL) in complete remission, myelodysplastic syndrome, chronic lymphocytic leukemia, lymphoma, non-malignant disorders, severe aplastic anemia, hemoglobinopathies and metabolic disorders
MedDRA version: 9.1Level: LLTClassification code 10018799Term: GVHD
Trade Name: Rapamune
Product Name: Rapamune
INN or Proposed INN: SIROLIMUS
Other descriptive name: Rapamycin
Trade Name: Prograf
Product Name: Prograf
INN or Proposed INN: TACROLIMUS
Other descriptive name: FK-506
Trade Name: Sandimmun Neoral
Product Name: Sandimmun Neoral
INN or Proposed INN: CICLOSPORIN
Other descriptive name: CsA
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Finland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
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PhaseCountries
16NCT01231841March 200529/10/2010Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic AnemiaProtocol for Prospective Phase II Study of Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin) and Cyclosporine (CsA) as a First Line Immunosuppressive (IS) Therapy for Severe Aplastic Anemia (sAA)Aplastic AnemiaDrug: cyclosporine;Biological: anti-thymocyte globulinThe Cleveland ClinicNULLCompleted12 YearsN/AAll20Phase 2United States
17NCT00001964December 2, 199918/1/2000Combination Therapy of Severe Aplastic AnemiaTreatment of Severe Aplastic Anemia With Combined Immunosuppression: Antithymocyte Globulin (ATG) and Cyclosporine A (CSA), and Mycophenolate Mofetil (MMF)Severe Aplastic AnemiaDrug: Cyclosporine A;Drug: ATG;Drug: MMFNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted1 Year99 YearsAll104Phase 2United States