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 | NCT05600426 (ClinicalTrials.gov) | January 25, 2023 | 20/10/2022 | A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202) | A Phase III Randomized Trial Comparing Unrelated Donor Bone Marrow Transplantation With Immune Suppressive Therapy for Newly Diagnosed Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202) | Severe Aplastic Anemia | Drug: cyclosporine;Procedure: Matched Unrelated Donor Hematopoetic Stem Cell Transplant;Drug: horse anti-thymocyte globulin (ATG);Drug: rabbit anti-thymocyte globulin (ATG);Drug: Methotrexate;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: low-dose total body irradiation (TBI);Procedure: Immunosuppressive Therapy (IST) | Boston Children's Hospital | Center for International Blood and Marrow Transplant Research;National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);North American Pediatric Aplastic Anemia Consortium;Pediatric Transplantation and Cellular Therapy Consortium;Blood and Marrow Transplant Clinical Trials Network | Recruiting | 0 Years | 25 Years | All | 234 | Phase 3 | United States |
| 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 | ChiCTR2100047288 | 2021-06-01 | 2021-06-11 | Efficacy and safety of combined immunosuppressive therapy plus umbilical cord blood infusion in myelodysplastic syndromes/aplastic anemia patients: a clinical observation study | Efficacy and safety of combined immunosuppressive therapy plus umbilical cord blood infusion in myelodysplastic syndromes/aplastic anemia patients: a clinical observation study | myelodysplastic syndromes/aplastic anemi | Experimental 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) | NULL | Recruiting | 18 | 90 | Both | Experimental group1:10;Experimental group2:10; | China | |
| 4 | NCT04328727 (ClinicalTrials.gov) | November 4, 2020 | 9/3/2020 | Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia | A 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 Pharmaceuticals | NULL | Active, not recruiting | 6 Years | N/A | All | 36 | Phase 2 | China;Japan;Korea, Republic of;Taiwan |
| 5 | JPRN-jRCTs071190032 | 26/11/2019 | 21/10/2019 | W-JHS AA02 | Investigation on the effectiveness of rabbit ATG + cyclosporine + eltrombopag therapy for patients with aplastic anemia - W-JHS AA02 | aplastic anemia | 1. 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 Ken | NULL | Recruiting | >= 18age old | < 80age old | Both | 60 | Phase 2 | Japan |
| 6 | ChiCTR1800019669 | 2019-01-01 | 2018-11-21 | A randomized, open-label, single-center controlled trial for the efficacy and safety of recombinant human thrombopoietin injection in the treatment of severe Aplastic Anemia with thrombocytopenia | A randomized, open-label, single-center controlled trial for the efficacy and safety of recombinant human thrombopoietin injection in the treatment of severe Aplastic Anemia with thrombocytopenia | Aplastic anemia,Thrombocytopenia | Group 1:Add rhTPO, 300U/kg qd after ATG treatment for 8 weeks;Group 2:Add rhTPO, 300U/kg qod after ATG treatment for 8 weeks; | Institute of Hematology, People's Hospital, Peking University | NULL | Pending | Both | Group 1:30;Group 2:30; | China | |||
| 7 | NCT03295058 (ClinicalTrials.gov) | January 1, 2019 | 24/9/2017 | Peripheral Blood Allogenic Stem Cell Transplantation Using Non-anti Thymocyte Globulin Regimens in Severe Aplastic Anemia Patients | Outcome of Peripheral Blood Allogenic Stem Cell Transplantation Using Non-anti Thymocyte Globulin (ATG ) Conditioning Regimens in Severe Aplastic Anemia Patients | Severe Aplastic Anemia | Drug: Non ATG Conditioning regimen;Drug: GVHD Prophylaxis;Procedure: Allogenic Stem Cell Transplantation;Drug: ATG conditioning regimen | Assiut University | NULL | Unknown status | 16 Years | 50 Years | All | 50 | Phase 2/Phase 3 | NULL |
| 8 | 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 |
| 9 | 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 |
| 10 | NCT02838992 (ClinicalTrials.gov) | February 2017 | 6/7/2016 | ATG Combined With Cyclophosphamide And Cord Blood Transfusion in Treating Patients With Severe Aplastic Anemia | Multi-center Clinical Study of Immunosuppressants, Cyclophosphamide, And Cord Blood Transfusion in Treating Patients With Severe Aplastic Anemia | Aplastic Anemia | Drug: Rabbit ATG, (Genzyme);Drug: Cy;Drug: CsA;Biological: Cord blood | Jinan Military General Hospital | Shandong 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 Hospital | Not yet recruiting | 1 Year | 60 Years | All | 130 | Phase 4 | China |
| 11 | NCT03413306 (ClinicalTrials.gov) | December 10, 2016 | 22/12/2017 | Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AA | A 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 Anemia | Acquired Aplastic Anemia | Drug: Eltrombopag;Drug: IST (ATG + CsA) | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | NULL | Recruiting | 2 Years | 18 Years | All | 100 | Phase 3 | Russian Federation |
| 12 | NCT02828592 (ClinicalTrials.gov) | September 9, 2016 | 6/7/2016 | Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia | A Study of T-Cell Replete, HLA-Mismatched Haploidentical Bone Marrow Transplantation With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia Lacking HLA-Matched Related Donor | Severe Aplastic Anemia | Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation;Drug: Rabbit ATG | Northside Hospital, Inc. | NULL | Recruiting | 1 Year | 75 Years | All | 20 | Phase 2 | United States |
| 13 | NCT02845596 (ClinicalTrials.gov) | August 2016 | 9/5/2016 | Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic Anemia | Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic Anemia | Severe Aplastic Anemia | Drug: cyclosporine;Procedure: Matched Unrelated Donor Hematopoietic Stem Cell Transplant;Drug: horse anti-thymocyte globulin (ATG);Drug: rabbit anti-thymocyte globulin (ATG);Drug: methotrexate;Drug: fludarabine;Drug: cyclophosphamide;Radiation: low-dose total body irradiation (TBI);Procedure: Immunosuppressive Therapy (IST) | Michael Pulsipher, MD | NULL | Active, not recruiting | N/A | 25 Years | All | 40 | N/A | United States |
| 14 | NCT02404025 (ClinicalTrials.gov) | May 12, 2015 | 26/2/2015 | Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) Subjects | A 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 Therapy | Aplastic Anemia | Drug: Eltrombopag;Drug: Rabbit ATG;Drug: CsA | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 2 | Japan |
| 15 | NCT02407470 (ClinicalTrials.gov) | January 2015 | 25/3/2015 | Safety and Efficacy of Patient's Own AD-MSC and AD-HSC Transplantation in Patients With Severe Aplastic Anemia | A Multicenter, Randomized, Controlled Study of the Efficacy and Safety of the Combination of Adipose Tissue-derived Hematopoietic Stem Cells (AD-HSCs) and ATG in the Treatment of Severe Aplastic Anemia | Severe Aplastic Anemia | Drug: Rabbit antithymoglobulin (ATG);Procedure: Adipose derived mesenchymal stem cells ( AD-MSCs);Procedure: AD-MSC transdifferentiated HSCs (AD-HSCs) | Navy General Hospital, Beijing | Peking Union Medical College Hospital;General Hospital of Beijing PLA Military Region;Chinese Academy of Medical Sciences | Recruiting | 14 Years | 70 Years | Both | 90 | Phase 1/Phase 2 | China |
| 16 | NCT02203396 (ClinicalTrials.gov) | August 2014 | 27/7/2014 | A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic Anemia | A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic Anemia | Aplastic Anemia | Drug: rabbit ATG, Cyclosporine, Levamisole | Yizhou Zheng | NULL | Recruiting | 6 Years | 70 Years | Both | 40 | Phase 2 | China |
| 17 | NCT02028416 (ClinicalTrials.gov) | September 2013 | 2/1/2014 | Comparison of Two Different Doses of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic Anaemia | Protocol for Comparison of Two Different Regimens of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic Anaemia | Aplastic Anemia | Drug: ATG-fresenius | National Institute of Blood Disease Center, Pakistan | NULL | Recruiting | 2 Years | 65 Years | Both | 60 | N/A | Pakistan |
| 18 | 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 |
| 19 | JPRN-UMIN000006071 | 2011/08/01 | 31/08/2011 | Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin | Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin - HSCT for AA using low-dose ATG | SAA | Conditioning regimen Fludarabine 30mg/m2/day iv day-6,-5,-4,-3 Cyclophosphamide 25mg/kg/day iv day-6,-5,-4,-3 ATG(thymoglobulin) 1.25mg/kg iv day-4,-3 In case of HSCT from unrelated donor or HLA-mismatched related donor, TBI 2Gy day-1 will be added. | Kanto Study Group for Cell Therapy | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 28 | Phase 2 | Japan |
| 20 | NCT01997372 (ClinicalTrials.gov) | December 2010 | 1/3/2012 | Different Doses of Anti-thymocyte Globin to Treat Child Severe Aplastic Anemia | Different Doses of Anti-thymocyte Globin With 2.5 or 3.75mg/kg to Treat Child Severe Aplastic Anemia | Severe Aplastic Anemia | Drug: ATG | Chinese Academy of Medical Sciences | NULL | Recruiting | 1 Year | 18 Years | Both | 100 | Phase 4 | China |
| 21 | NCT01145976 (ClinicalTrials.gov) | March 2010 | 19/5/2010 | Comparison of Cy-Atg vs Flu-Atg for the Conditioning Therapy in Allo-HCT for Adult Aplastic Anemia | Randomized Comparison of Cyclophosphamide Versus Fludarabine in Addition to Anti-thymocyte Globulin for the Conditioning Therapy in Allogeneic Hematopoietic Cell Transplantation for Adult Acquired Aplastic Anemia | Aplastic Anemia | Drug: Cy-ATG;Drug: Flu-ATG | Cooperative Study Group A for Hematology | NULL | Recruiting | 15 Years | 65 Years | Both | 98 | Phase 3 | Korea, Republic of |
| 22 | 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 | ||
| 23 | NCT01129323 (ClinicalTrials.gov) | November 2009 | 21/4/2010 | Reduced-Intensity Preparative Regimen for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic Anemia | Reduced-Intensity Preparative Regimen for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic Anemia | Severe Aplastic Anemia | Drug: Cyclophosphamide, Fludarabine, Rabbit ATG | City of Hope Medical Center | NULL | Withdrawn | N/A | 21 Years | Both | 0 | N/A | United States |
| 24 | NCT00987480 (ClinicalTrials.gov) | September 25, 2009 | 30/9/2009 | Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine | A Multicenter Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine | Aplastic Anemia;Leukemia;Myelodysplastic Syndrome | Drug: Busulfan, fludarabine, & cyclophosphamide with immunosuppression with ATG and cyclosporine.;Device: CliniMACS device | Memorial Sloan Kettering Cancer Center | Boston Children's Hospital;Children's Hospital Medical Center, Cincinnati;Children's Hospital and Health System Foundation, Wisconsin;Rockefeller University;Fred Hutchinson Cancer Research Center | Completed | N/A | N/A | All | 45 | Phase 2 | United States |
| 25 | NCT00944749 (ClinicalTrials.gov) | July 2009 | 22/7/2009 | Horse ATG/CsA in Aplastic Anemia Patients Unresponsive to or With a Suboptimal Response to Rabbit ATG/CsA Treatment | Horse ATG/CsA in Aplastic Anemia Patients Unresponsive to or With a Suboptimal Response to Rabbit ATG/CsA Treatment | Anemia, Aplastic;Anemia, Hypoplastic | Drug: h-ATG (ATGAM );Drug: Cyclosporine (Gengraf ) | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 2 Years | 82 Years | All | 23 | Phase 2 | United States |
| 26 | 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 |
| 27 | 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 | ||
| 28 | 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 |
| 29 | 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 | ||
| 30 | NCT00260689 (ClinicalTrials.gov) | November 28, 2005 | 1/12/2005 | Three Immunosuppressive Treatment Regimens for Severe Aplastic Anemia | A Randomized Study of Three Immunosuppressive Regimens in Treatment Naive Patients With Severe Aplastic Anemia: Horse ATG/CsA Taper vs Rabbit-ATG/CsA vs Alemtuzumab | Immunosuppresion;Thrombocytopenia;Pancytopenia;Neutropenia | Biological: Anti-thymocyte globulin (rabbit);Biological: Anti-thymocyte globulin (horse);Drug: Cyclosporine;Drug: Alemtuzumab | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 2 Years | N/A | All | 136 | Phase 2 | United States |
| 31 | 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 |
| 32 | 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 |
| 33 | NCT00061360 (ClinicalTrials.gov) | June 26, 2003 | 23/5/2003 | Improving Immunosuppressive Treatment for Patients With Severe Aplastic Anemia | A Randomized Trial of a Novel Immunosuppressive Combination of ATG, CsA and Sirolimus (Rapamune) vs a Slow Taper Cyclosporine Regimen in Subjects With Severe Aplastic Anemia | Severe Aplastic Anemia | Drug: ATG+Rapamune+cyclosporine;Drug: ATG+cyclosporine | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 2 Years | 110 Years | All | 77 | Phase 2 | United States |
| 34 | 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 |
| 35 | 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 |
| 36 | NCT01499147 (ClinicalTrials.gov) | February 2000 | 23/11/2011 | Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies | Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies | Acute Myeloid Leukemia;Acute Leukemia;Chronic Myelogenous Leukemia;Malignant Lymphoma;Hodgkin's Disease;Multiple Myeloma;Lymphocytic Leukemia;Myeloproliferative Disorder;Polycythemia Vera;Myelofibrosis;Aplastic Anemia | Drug: fludarabine/busulfan;Drug: fludarabine/ melphalan;Drug: ATG | University of Illinois at Chicago | NULL | Completed | 10 Years | 65 Years | All | 100 | N/A | United States |
| 37 | EUCTR2021-002155-11-Outside-EU/EEA (EUCTR) | 09/06/2021 | Open-label, single-arm, multicenter study in Japanese patients with aplastic anemia | A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ACCESS THE EFFICACY AND SAFETY OF PF-06462700 ADMINISTERED INTRAVENOUSLY AT 40 MG/KG/DAY FOR 4 DAYS IN JAPANESE PARTICIPANTS WITH MODERATE AND ABOVE APLASTIC ANEMIA | Moderate and above aplastic anemia;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Atgam Product Name: Atgam INN or Proposed INN: Anti-human T-lymphocyte immunoglobulin from horse Other descriptive name: anti-human immunoglobulin, equine | Pfizer Inc. | NULL | NA | Female: yes Male: yes | Phase 3 | Japan |