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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05323617 (ClinicalTrials.gov) | May 15, 2023 | 5/4/2022 | Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Therapy | Two Arm Bridging Study to Evaluate the Efficacy of Romiplostim in the Treatment of Adult Severe Aplastic Anemia Participants Who Are Either Previously Untreated With IST or Refractory to IST | Severe Aplastic Anemia (SAA) | Drug: Romiplostim;Drug: Antithymocyte Globulin;Drug: Cyclosporine A | Amgen | NULL | Not yet recruiting | 18 Years | N/A | All | 40 | Phase 2 | NULL |
| 2 | NCT05049668 (ClinicalTrials.gov) | October 2021 | 13/9/2021 | RACE 2: a Long Term Follow-up of Patients Participating in the RACE Trial | Long-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 Patients | Severe Aplastic Anemia | Drug: ATGAM plus CsA with or without Eltrombopag | European Society for Blood and Marrow Transplantation | NULL | Enrolling by invitation | N/A | N/A | All | 197 | France | |
| 3 | NCT03531736 (ClinicalTrials.gov) | May 9, 2018 | 9/5/2018 | T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia | Allogeneic Hematopoietic Stem Cell Transplantation of a/ß T-Lymphocyte Depleted Graft Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia | Myeloid Diseases | Drug: Antithymocyte globulin (Rabbit);Drug: fludarabine;Radiation: total body irradiation;Drug: cyclophosphamide;Drug: Rituxan;Procedure: Allogeneic Hematopoietic Stem Cell Transplantation | Memorial Sloan Kettering Cancer Center | NULL | Recruiting | 18 Years | N/A | All | 15 | Phase 1 | United States |
| 4 | NCT03318159 (ClinicalTrials.gov) | April 20, 2018 | 10/10/2017 | Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients | Open Label, Phase II Study Investigating the Efficacy of Posaconazole as Prophylaxis Antifungal Agent in Aplastic Anemia / Hypoplastic Myelodysplastic Syndrome Patients Undergoing Antithymocyte Globulin Treatment | Aplastic Anemia;Myelodysplastic Syndromes;Fungal Infection | Drug: Posaconazole | Seoul National University Hospital | Merck Sharp & Dohme Corp. | Unknown status | 18 Years | 75 Years | All | 40 | Phase 2 | Korea, Republic of |
| 5 | NCT02918292 (ClinicalTrials.gov) | July 3, 2017 | 27/9/2016 | Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502) | Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP) (BMT CTN 1502) | Severe Aplastic Anemia | Drug: Antithymocyte Globulin (ATG);Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation (TBI);Procedure: Haplo HSCT;Drug: Tacrolimus;Drug: Mycophenolate mofetil (MMF);Drug: G-CSF | Medical College of Wisconsin | National Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI);Blood and Marrow Transplant Clinical Trials Network;National Marrow Donor Program | Completed | N/A | 75 Years | All | 32 | Phase 2 | United States |
| 6 | EUCTR2014-000363-40-NL (EUCTR) | 07/01/2016 | 01/09/2015 | A 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 Transplantation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Spain;Netherlands | ||
| 7 | EUCTR2014-000363-40-ES (EUCTR) | 26/10/2015 | 07/09/2015 | A 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 Transplantation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Spain | |||
| 8 | NCT02099747 (ClinicalTrials.gov) | July 2015 | 6/3/2014 | hATG+CsA vs hATG+CsA+Eltrombopag for SAA | 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. | Severe Aplastic Anemia | Drug: hATG;Drug: CsA;Drug: Eltrombopag | European Group for Blood and Marrow Transplantation | Novartis;Pfizer | Active, not recruiting | 15 Years | N/A | All | 202 | Phase 3 | France;Italy;Netherlands;Spain;Switzerland;United Kingdom;Germany |
| 9 | NCT01844635 (ClinicalTrials.gov) | May 2012 | 29/4/2013 | Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA | A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia | Acquired Aplastic Anemia. | Drug: Thymoglobulin | Nagoya University | NULL | Recruiting | N/A | 69 Years | Both | 320 | Phase 3 | Japan |
| 10 | EUCTR2007-000902-55-DE (EUCTR) | 17/12/2009 | 29/09/2009 | Prospective Phase II Pilot study of Rabbit Antithymocyte globulin(ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients withAcquired Aplastic Anaemia and comparison with matched historicalpatients treated with horse ATG and Ciclosporin: a Study from theEuropean Blood and Marrow Transplant (EBMT) Severe AplasticAnaemia Working Party | Prospective Phase II Pilot study of Rabbit Antithymocyte globulin(ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients withAcquired Aplastic Anaemia and comparison with matched historicalpatients treated with horse ATG and Ciclosporin: a Study from theEuropean Blood and Marrow Transplant (EBMT) Severe AplasticAnaemia Working Party | Acquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemia MedDRA version: 12.0;Level: LLT;Classification code 10002969;Term: Aplastic anemia | Trade Name: Thymoglobulin Product Name: Thymoglobuline®/Thymoglobulin® Product Code: anti-thymocyte globulin (rabbit) | EBMT (European Group for Blood and Marrow Transplantation) | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | France;Germany;United Kingdom | ||
| 11 | NCT01105273 (ClinicalTrials.gov) | July 2009 | 8/4/2010 | Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Aplastic Anemia | HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3±CD19 Depletion for Patients With Aplastic Anemia After Conditioning of Fludarabine, Cyclophosphamide and Antithymocyte Globulin | Aplastic Anemia | Biological: anti-thymocyte globulin;Biological: filgrastim;Drug: Fludarabine;Drug: Cyclophosphamide;Procedure: CD3±CD19 depleted hematopoietic stem cell transplantation | Asan Medical Center | NULL | Completed | N/A | 21 Years | Both | 12 | Phase 1/Phase 2 | Korea, Republic of |
| 12 | EUCTR2009-012746-23-IT (EUCTR) | 12/05/2009 | 24/06/2009 | pilot study of second line therapy for AAA Acquired Aplastic Anemia with antithymocyte globulin, cyclosporin and etanercept - ND | pilot study of second line therapy for AAA Acquired Aplastic Anemia with antithymocyte globulin, cyclosporin and etanercept - ND | acquired aplastic anemia MedDRA version: 9.1;Level: SOC;Classification code 10005329 | Trade Name: ENBREL*SC 4FL 25MG+4SIR 1ML INN or Proposed INN: Etanercept | ISTITUTO GIANNINA GASLINI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 13 | NCT00882323 (ClinicalTrials.gov) | November 2008 | 15/4/2009 | Reduced Toxicity Fludarabine (Flu) + Cyclophosphamide (CPM) + Rabbit Antithymocyte Globulin (rATG) Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia (SAA) | Reduced Toxicity Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia | Aplastic Anemia | Drug: Cyclophosphamide, Fludarabine, Thymoglobulin | The Korean Society of Pediatric Hematology Oncology | NULL | Recruiting | 1 Year | 21 Years | Both | 33 | Phase 2 | Korea, Republic of |
| 14 | NCT00471848 (ClinicalTrials.gov) | August 2008 | 9/5/2007 | Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic Anaemia | Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia and Comparison With Matched Historical Patients Treated With Horse ATG and Ciclosporin | Aplastic Anemia | Drug: rabbit antithymocyte globulin | European Group for Blood and Marrow Transplantation | Genzyme, a Sanofi Company | Active, not recruiting | 16 Years | N/A | Both | 35 | Phase 2 | France;Germany;Italy;Saudi Arabia;Switzerland;United Kingdom |
| 15 | EUCTR2007-000902-55-FR (EUCTR) | 23/04/2008 | 04/10/2007 | Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin | Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin | Aquired aplastic anaemia and transfusion dependent non-severe aplastic anaemia MedDRA version: 9.1;Level: LLT;Classification code 10002274;Term: Anemia aplastic | Trade Name: Thymoglobuline Product Name: Thymoglobuline®/Thymoglobulin® Product Code: anti-thymocyte globulin (rabbit) Other descriptive name: GLYCINE Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: Mannitol Trade Name: Neoral Product Name: Ciclosporine INN or Proposed INN: Cyclosporin A Other descriptive name: Ciclosporine | EBMT (European group for Blood and Marrow Transplantation) | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | France;Germany;United Kingdom | ||
| 16 | NCT01530555 (ClinicalTrials.gov) | April 2008 | 24/1/2012 | Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia | Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia | Acquired Aplastic Anaemia | Drug: Rabbit ATG, Thymoglobuline (Genzyme) | King Faisal Specialist Hospital & Research Center | NULL | Completed | 16 Years | 80 Years | Both | 35 | Phase 2 | NULL |
| 17 | EUCTR2007-000902-55-GB (EUCTR) | 19/09/2007 | 26/06/2007 | Prospective Phase II study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin | Prospective Phase II study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin | Acquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemia MedDRA version: 14.0;Level: LLT;Classification code 10002274;Term: Anemia aplastic;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: Thymoglobuline Product Name: Thymoglobuline®/Thymoglobulin® Product Code: anti-thymocyte globulin (rabbit) INN or Proposed INN: GLYCINE INN or Proposed INN: Sodium chloride INN or Proposed INN: Mannitol | EBMT (European group for Blood and Marrow Transplantation) | NULL | Not Recruiting | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Germany;United Kingdom | ||
| 18 | NCT00455312 (ClinicalTrials.gov) | August 2007 | 30/3/2007 | Stem Cell Transplant (SCT) for Dyskeratosis Congenita or SAA | Hematopoietic Stem Cell Transplant For Patients With Dyskeratosis Congenita and Severe Aplastic Anemia | Dyskeratosis Congenita;Aplastic Anemia | Drug: Campath 1H;Drug: Cyclophosphamide;Drug: Fludarabine;Procedure: Total Body Irradiation;Procedure: Stem Cell Transplantation;Drug: antithymocyte globulin;Drug: Methylprednisolone | Masonic Cancer Center, University of Minnesota | NULL | Completed | N/A | 70 Years | All | 36 | Phase 2/Phase 3 | United States |
| 19 | NCT00474747 (ClinicalTrials.gov) | February 7, 2006 | 16/5/2007 | Fludarabine-Based Conditioning for Allogeneic Marrow Transplantation in Aplastic Anemia | Fludarabine-Based Conditioning for Allogeneic Marrow Transplantation From HLA-Compatible Unrelated Donors in Severe Aplastic Anemia | Aplastic Anemia | Drug: Antithymocyte Globulin;Drug: Cyclophosphamide;Drug: Fludarabine;Radiation: Total Body Irradiation (TBI);Procedure: Bone Marrow Transplant | M.D. Anderson Cancer Center | National Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI) | Completed | N/A | 65 Years | All | 5 | Phase 1/Phase 2 | United States |
| 20 | NCT00354419 (ClinicalTrials.gov) | February 2006 | 19/7/2006 | Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood Transplant | A Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord Blood | Aplastic Anemia | Radiation: total-body irradiation;Drug: cyclophosphamide;Biological: anti-thymocyte globulin;Drug: cyclosporine;Procedure: umbilical cord blood transplantation;Drug: mycophenolate mofetil;Procedure: bone marrow aspiration;Genetic: DNA analysis;Biological: filgrastim | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Terminated | N/A | 40 Years | Both | 30 | Phase 1 | United States |
| 21 | NCT00343785 (ClinicalTrials.gov) | February 2006 | 22/6/2006 | Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant | Cyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center Trial | Aplastic Anemia | Drug: cyclophosphamide;Biological: anti-thymocyte globulin;Drug: cyclosporine;Procedure: allogeneic bone marrow transplantation;Drug: methotrexate;Genetic: DNA analysis;Other: flow cytometry;Genetic: polymorphism analysis;Other: laboratory biomarker analysis | Fred Hutchinson Cancer Research Center | National Heart, Lung, and Blood Institute (NHLBI) | Completed | N/A | 65 Years | All | 21 | Phase 2 | United States;Canada |
| 22 | NCT01231841 (ClinicalTrials.gov) | March 2005 | 29/10/2010 | Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic Anemia | Protocol 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 Anemia | Drug: cyclosporine;Biological: anti-thymocyte globulin | The Cleveland Clinic | NULL | Completed | 12 Years | N/A | All | 20 | Phase 2 | United States |
| 23 | NCT00065260 (ClinicalTrials.gov) | July 2003 | 18/7/2003 | Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia | A Randomized Trial of Immunosuppression in Aplastic Anemia Patients With Refractory Pancytopenia or Suboptimal Hematologic Response After h-ATG/CsA Treatment | Aplastic Anemia | Drug: Campath-1H;Drug: r-ATG;Drug: CsA | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 2 Years | N/A | All | 54 | Phase 2 | United States |
| 24 | NCT01163942 (ClinicalTrials.gov) | March 2001 | 14/7/2010 | Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF) | A RANDOMIZED CONTROLLED STUDY IN NEWLY DIAGNOSED SEVERE APLASTIC ANEMIA PATIENTS RECEIVING ANTITHYMOCYTE GLOBULIN (ATG), CYCLOSPORIN A, WITH OR WITHOUT G-CSF | Aplastic Anaemia | Drug: G-CSF;Drug: Early retreatment with ATG | European Group for Blood and Marrow Transplantation | CHUGAI sanofi-aventis | Terminated | N/A | N/A | Both | 205 | Phase 3 | Czech Republic;France;Germany;Greece;Italy;Netherlands;Sweden;Switzerland;United Kingdom |
| 25 | NCT00427336 (ClinicalTrials.gov) | December 2000 | 25/1/2007 | Purine Analog-Based Conditioning in Patients With Severe Aplastic Anemia | Purine Analog-Based Conditioning for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic Anemia | Aplastic Anemia | Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Antithymocyte Globulin | M.D. Anderson Cancer Center | NULL | Completed | N/A | 70 Years | All | 9 | N/A | United States |
| 26 | NCT00001964 (ClinicalTrials.gov) | March 17, 2000 | 18/1/2000 | Combination Therapy of Severe Aplastic Anemia | Treatment of Severe Aplastic Anemia With Combined Immunosuppression: Antithymocyte Globulin (ATG) and Cyclosporine A (CSA), and Mycophenolate Mofetil (MMF) | Severe Aplastic Anemia | Drug: Cyclosporine A;Drug: ATG;Drug: MMF | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 1 Year | 99 Years | All | 104 | Phase 2 | United States |
| 27 | NCT00004474 (ClinicalTrials.gov) | September 1998 | 18/10/1999 | Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia | Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia | Aplastic Anemia | Drug: Anti-thymocyte globulin;Drug: Cyclophosphamide;Procedure: Bone marrow transplantation | Roswell Park Cancer Institute | NULL | Completed | N/A | 59 Years | All | 224 | Phase 3 | United States |
| 28 | NCT00001626 (ClinicalTrials.gov) | June 2, 1997 | 3/11/1999 | Comparing Therapies for the Treatment of Severe Aplastic Anemia | A Randomized Trial of Antithymocyte Globulin and Cyclosporine Versus Cyclophosphamide and Cyclosporine in the Treatment of Severe Aplastic Anemia | Severe Aplastic Anemia (SAA) | Drug: antithymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 15 Years | 110 Years | All | 33 | Phase 2 | United States |