60. 再生不良性貧血 Aplastic anemia Clinical trials / Disease details


臨床試験数 : 245 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166

  
9 trials found
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1NCT05049668
(ClinicalTrials.gov)
October 202113/9/2021RACE 2: a Long Term Follow-up of Patients Participating in the RACE TrialLong-term Follow-up of Patients Participating in RACE: the Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia PatientsSevere Aplastic AnemiaDrug: ATGAM plus CsA with or without EltrombopagEuropean Society for Blood and Marrow TransplantationNULLEnrolling by invitationN/AN/AAll197France
2NCT03025698
(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 PharmaceuticalsNULLActive, not recruiting1 Year18 YearsAll51Phase 2United States;Hong Kong;Portugal;Russian Federation;Thailand;United Kingdom;Netherlands
3NCT03413306
(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
4EUCTR2014-000363-40-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
5EUCTR2014-000363-40-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
6NCT02462252
(ClinicalTrials.gov)
October 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
7NCT02099747
(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
8NCT01623167
(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
9NCT01624805
(ClinicalTrials.gov)
June 25, 201219/6/2012Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic SyndromePhase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplastic Syndrome (MDS)Aplastic Anemia;de Novo Myelodysplastic Syndrome;Myelodysplastic Syndrome;Previously Treated Myelodysplastic SyndromeBiological: Anti-Thymocyte Globulin;Drug: Cyclosporine;Biological: Filgrastim;Drug: Methylprednisolone;Biological: PegfilgrastimM.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingN/AN/AAll100Phase 2United States