60. Aplastic anemia Clinical trials / Disease details


Clinical trials : 235 Drugs : 381 - (DrugBank : 83) / Drug target genes : 44 - Drug target pathways : 160

  
20 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
2ChiCTR2100047288
2021-06-012021-06-11Efficacy and safety of combined immunosuppressive therapy plus umbilical cord blood infusion in myelodysplastic syndromes/aplastic anemia patients: a clinical observation studyEfficacy and safety of combined immunosuppressive therapy plus umbilical cord blood infusion in myelodysplastic syndromes/aplastic anemia patients: a clinical observation study myelodysplastic syndromes/aplastic anemiExperimental group1:According to the classification, ATG + CsA/CSA alone is used as the pretreatment plan/supportive treatment + non-blood cord blood stem cell infusion treatment;Experimental group2:Decitabine+cytarabine/decitabine alone is used as the pretreatment plan/supportive treatment+non-blood cord blood stem cell infusion treatment according to the classification;The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)NULLRecruiting1890BothExperimental group1:10;Experimental group2:10;China
3NCT04328727
(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 PharmaceuticalsNULLActive, not recruiting6 YearsN/AAll36Phase 2China;Japan;Korea, Republic of;Taiwan
4JPRN-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).
Ishiyama KenNULLRecruiting>= 18age old< 80age oldBoth60Phase 2Japan
5JPRN-UMIN000030453
2017/12/2018/12/2017Efficacy 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 KyushuNULLComplete: follow-up continuing16years-oldNot applicableMale and Female33Not selectedJapan
6NCT03025698
(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
7NCT02838992
(ClinicalTrials.gov)
February 20176/7/2016ATG Combined With Cyclophosphamide And Cord Blood Transfusion in Treating Patients With Severe Aplastic AnemiaMulti-center Clinical Study of Immunosuppressants, Cyclophosphamide, And Cord Blood Transfusion in Treating Patients With Severe Aplastic AnemiaAplastic AnemiaDrug: Rabbit ATG, (Genzyme);Drug: Cy;Drug: CsA;Biological: Cord bloodJinan Military General HospitalShandong University of Traditional Chinese Medicine;Jining Medical University;Affiliated Hospital of Weifang Medical University;Guangzhou First People's Hospital;Harbin Hematology and Oncology Institute;JINING No.1 People's Hospital;JIANGXI Provincal People's Hospital;Jinhua Central Hospital;Linyi People's Hospital;Shandong Cord Blood Bank;Qingdao Center Medical Group;Qingdao University;Taian City Central Hospital;Yantai Yuhuangding Hospital;Yishui Central Hospital of LINYI;Institute of Hematology & Blood Diseases Hospital;Shengjing HospitalNot yet recruiting1 Year60 YearsAll130Phase 4China
8NCT03413306
(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
9EUCTR2014-000363-40-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
10EUCTR2014-000363-40-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
11NCT02099747
(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
12NCT02404025
(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
13NCT02773225
(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
14NCT01623167
(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
15EUCTR2006-006577-25-SE
(EUCTR)
25/07/200711/06/2007A 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: 9.1;Level: LLT;Classification code 10018799;Term: 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
16NCT01231841
(ClinicalTrials.gov)
March 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
17NCT00065260
(ClinicalTrials.gov)
July 200318/7/2003Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic AnemiaA Randomized Trial of Immunosuppression in Aplastic Anemia Patients With Refractory Pancytopenia or Suboptimal Hematologic Response After h-ATG/CsA TreatmentAplastic AnemiaDrug: Campath-1H;Drug: r-ATG;Drug: CsANational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted2 YearsN/AAll54Phase 2United States
18NCT00061360
(ClinicalTrials.gov)
June 26, 200323/5/2003Improving Immunosuppressive Treatment for Patients With Severe Aplastic AnemiaA Randomized Trial of a Novel Immunosuppressive Combination of ATG, CsA and Sirolimus (Rapamune) vs a Slow Taper Cyclosporine Regimen in Subjects With Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: ATG+Rapamune+cyclosporine;Drug: ATG+cyclosporineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted2 Years110 YearsAll77Phase 2United States
19NCT00005935
(ClinicalTrials.gov)
June 20006/7/2000Mycophenolate Mofetil and Cyclosporine to Treat Relapsing Aplastic AnemiaA Randomized Trial for the Treatment of Relapsing Aplastic Anemia With Mycophenolate Mofetil (MMF) and Cyclosporine (CSA)Aplastic AnemiaDrug: Mycophenolate mofetil;Drug: CyclosporineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompletedN/AN/ABoth130Phase 2United States
20NCT00001964
(ClinicalTrials.gov)
March 17, 200018/1/2000Combination 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