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

  
37 trials found
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1NCT05600426
(ClinicalTrials.gov)
January 25, 202320/10/2022A 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 AnemiaDrug: 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 HospitalCenter 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 NetworkRecruiting0 Years25 YearsAll234Phase 3United States
2NCT05049668
(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
3ChiCTR2100047288
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
4NCT04328727
(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
5JPRN-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
6ChiCTR1800019669
2019-01-012018-11-21A 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 thrombocytopeniaA 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,ThrombocytopeniaGroup 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 UniversityNULLPendingBothGroup 1:30;Group 2:30;China
7NCT03295058
(ClinicalTrials.gov)
January 1, 201924/9/2017Peripheral Blood Allogenic Stem Cell Transplantation Using Non-anti Thymocyte Globulin Regimens in Severe Aplastic Anemia PatientsOutcome of Peripheral Blood Allogenic Stem Cell Transplantation Using Non-anti Thymocyte Globulin (ATG ) Conditioning Regimens in Severe Aplastic Anemia PatientsSevere Aplastic AnemiaDrug: Non ATG Conditioning regimen;Drug: GVHD Prophylaxis;Procedure: Allogenic Stem Cell Transplantation;Drug: ATG conditioning regimenAssiut UniversityNULLUnknown status16 Years50 YearsAll50Phase 2/Phase 3NULL
8NCT03318159
(ClinicalTrials.gov)
April 20, 201810/10/2017Posaconazole Prophylaxis During ATG Treatment for hMDS/AA PatientsOpen Label, Phase II Study Investigating the Efficacy of Posaconazole as Prophylaxis Antifungal Agent in Aplastic Anemia / Hypoplastic Myelodysplastic Syndrome Patients Undergoing Antithymocyte Globulin TreatmentAplastic Anemia;Myelodysplastic Syndromes;Fungal InfectionDrug: PosaconazoleSeoul National University HospitalMerck Sharp & Dohme Corp.Unknown status18 Years75 YearsAll40Phase 2Korea, Republic of
9NCT02918292
(ClinicalTrials.gov)
July 3, 201727/9/2016Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP) (BMT CTN 1502)Severe Aplastic AnemiaDrug: Antithymocyte Globulin (ATG);Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation (TBI);Procedure: Haplo HSCT;Drug: Tacrolimus;Drug: Mycophenolate mofetil (MMF);Drug: G-CSFMedical College of WisconsinNational Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI);Blood and Marrow Transplant Clinical Trials Network;National Marrow Donor ProgramCompletedN/A75 YearsAll32Phase 2United States
10NCT02838992
(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
11NCT03413306
(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
12NCT02828592
(ClinicalTrials.gov)
September 9, 20166/7/2016Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic AnemiaA 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 DonorSevere Aplastic AnemiaDrug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation;Drug: Rabbit ATGNorthside Hospital, Inc.NULLRecruiting1 Year75 YearsAll20Phase 2United States
13NCT02845596
(ClinicalTrials.gov)
August 20169/5/2016Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic AnemiaUnrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: 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, MDNULLActive, not recruitingN/A25 YearsAll40N/AUnited States
14NCT02404025
(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
15NCT02407470
(ClinicalTrials.gov)
January 201525/3/2015Safety and Efficacy of Patient's Own AD-MSC and AD-HSC Transplantation in Patients With Severe Aplastic AnemiaA 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 AnemiaSevere Aplastic AnemiaDrug: Rabbit antithymoglobulin (ATG);Procedure: Adipose derived mesenchymal stem cells ( AD-MSCs);Procedure: AD-MSC transdifferentiated HSCs (AD-HSCs)Navy General Hospital, BeijingPeking Union Medical College Hospital;General Hospital of Beijing PLA Military Region;Chinese Academy of Medical SciencesRecruiting14 Years70 YearsBoth90Phase 1/Phase 2China
16NCT02203396
(ClinicalTrials.gov)
August 201427/7/2014A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic AnemiaA Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic AnemiaAplastic AnemiaDrug: rabbit ATG, Cyclosporine, LevamisoleYizhou ZhengNULLRecruiting6 Years70 YearsBoth40Phase 2China
17NCT02028416
(ClinicalTrials.gov)
September 20132/1/2014Comparison of Two Different Doses of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic AnaemiaProtocol for Comparison of Two Different Regimens of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic AnaemiaAplastic AnemiaDrug: ATG-freseniusNational Institute of Blood Disease Center, PakistanNULLRecruiting2 Years65 YearsBoth60N/APakistan
18NCT01844635
(ClinicalTrials.gov)
May 201229/4/2013Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAAA Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic AnemiaAcquired Aplastic Anemia.Drug: ThymoglobulinNagoya UniversityNULLRecruitingN/A69 YearsBoth320Phase 3Japan
19JPRN-UMIN000006071
2011/08/0131/08/2011Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulinAllogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin - HSCT for AA using low-dose ATG SAAConditioning 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 TherapyNULLComplete: follow-up complete16years-old65years-oldMale and Female28Phase 2Japan
20NCT01997372
(ClinicalTrials.gov)
December 20101/3/2012Different Doses of Anti-thymocyte Globin to Treat Child Severe Aplastic AnemiaDifferent Doses of Anti-thymocyte Globin With 2.5 or 3.75mg/kg to Treat Child Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: ATGChinese Academy of Medical SciencesNULLRecruiting1 Year18 YearsBoth100Phase 4China
21NCT01145976
(ClinicalTrials.gov)
March 201019/5/2010Comparison of Cy-Atg vs Flu-Atg for the Conditioning Therapy in Allo-HCT for Adult Aplastic AnemiaRandomized Comparison of Cyclophosphamide Versus Fludarabine in Addition to Anti-thymocyte Globulin for the Conditioning Therapy in Allogeneic Hematopoietic Cell Transplantation for Adult Acquired Aplastic AnemiaAplastic AnemiaDrug: Cy-ATG;Drug: Flu-ATGCooperative Study Group A for HematologyNULLRecruiting15 Years65 YearsBoth98Phase 3Korea, Republic of
22EUCTR2007-000902-55-DE
(EUCTR)
17/12/200929/09/2009Prospective 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 PartyProspective 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)NULLNot RecruitingFemale: yes
Male: yes
35Phase 2France;Germany;United Kingdom
23NCT01129323
(ClinicalTrials.gov)
November 200921/4/2010Reduced-Intensity Preparative Regimen for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic AnemiaReduced-Intensity Preparative Regimen for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: Cyclophosphamide, Fludarabine, Rabbit ATGCity of Hope Medical CenterNULLWithdrawnN/A21 YearsBoth0N/AUnited States
24NCT00987480
(ClinicalTrials.gov)
September 25, 200930/9/2009Hematopoietic 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 FludarabineA 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 FludarabineAplastic Anemia;Leukemia;Myelodysplastic SyndromeDrug: Busulfan, fludarabine, & cyclophosphamide with immunosuppression with ATG and cyclosporine.;Device: CliniMACS deviceMemorial Sloan Kettering Cancer CenterBoston Children's Hospital;Children's Hospital Medical Center, Cincinnati;Children's Hospital and Health System Foundation, Wisconsin;Rockefeller University;Fred Hutchinson Cancer Research CenterCompletedN/AN/AAll45Phase 2United States
25NCT00944749
(ClinicalTrials.gov)
July 200922/7/2009Horse ATG/CsA in Aplastic Anemia Patients Unresponsive to or With a Suboptimal Response to Rabbit ATG/CsA TreatmentHorse ATG/CsA in Aplastic Anemia Patients Unresponsive to or With a Suboptimal Response to Rabbit ATG/CsA TreatmentAnemia, Aplastic;Anemia, HypoplasticDrug: h-ATG (ATGAM );Drug: Cyclosporine (Gengraf )National Heart, Lung, and Blood Institute (NHLBI)NULLCompleted2 Years82 YearsAll23Phase 2United States
26NCT00471848
(ClinicalTrials.gov)
August 20089/5/2007Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic AnaemiaProspective 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 CiclosporinAplastic AnemiaDrug: rabbit antithymocyte globulinEuropean Group for Blood and Marrow TransplantationGenzyme, a Sanofi CompanyActive, not recruiting16 YearsN/ABoth35Phase 2France;Germany;Italy;Saudi Arabia;Switzerland;United Kingdom
27EUCTR2007-000902-55-FR
(EUCTR)
23/04/200804/10/2007Prospective 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 CiclosporinProspective 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)NULLNot RecruitingFemale: yes
Male: yes
35Phase 2France;Germany;United Kingdom
28NCT01530555
(ClinicalTrials.gov)
April 200824/1/2012Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic AnaemiaProspective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic AnaemiaAcquired Aplastic AnaemiaDrug: Rabbit ATG, Thymoglobuline (Genzyme)King Faisal Specialist Hospital & Research CenterNULLCompleted16 Years80 YearsBoth35Phase 2NULL
29EUCTR2007-000902-55-GB
(EUCTR)
19/09/200726/06/2007Prospective 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 CiclosporinProspective 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)NULLNot 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): noFrance;Germany;United Kingdom
30NCT00260689
(ClinicalTrials.gov)
November 28, 20051/12/2005Three Immunosuppressive Treatment Regimens for Severe Aplastic AnemiaA Randomized Study of Three Immunosuppressive Regimens in Treatment Naive Patients With Severe Aplastic Anemia: Horse ATG/CsA Taper vs Rabbit-ATG/CsA vs AlemtuzumabImmunosuppresion;Thrombocytopenia;Pancytopenia;NeutropeniaBiological: Anti-thymocyte globulin (rabbit);Biological: Anti-thymocyte globulin (horse);Drug: Cyclosporine;Drug: AlemtuzumabNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted2 YearsN/AAll136Phase 2United States
31NCT01231841
(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
32NCT00065260
(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
33NCT00061360
(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
34NCT01163942
(ClinicalTrials.gov)
March 200114/7/2010Randomized 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-CSFAplastic AnaemiaDrug: G-CSF;Drug: Early retreatment with ATGEuropean Group for Blood and Marrow TransplantationCHUGAI sanofi-aventisTerminatedN/AN/ABoth205Phase 3Czech Republic;France;Germany;Greece;Italy;Netherlands;Sweden;Switzerland;United Kingdom
35NCT00001964
(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
36NCT01499147
(ClinicalTrials.gov)
February 200023/11/2011Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic MalignanciesFludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic MalignanciesAcute Myeloid Leukemia;Acute Leukemia;Chronic Myelogenous Leukemia;Malignant Lymphoma;Hodgkin's Disease;Multiple Myeloma;Lymphocytic Leukemia;Myeloproliferative Disorder;Polycythemia Vera;Myelofibrosis;Aplastic AnemiaDrug: fludarabine/busulfan;Drug: fludarabine/ melphalan;Drug: ATGUniversity of Illinois at ChicagoNULLCompleted10 Years65 YearsAll100N/AUnited States
37EUCTR2021-002155-11-Outside-EU/EEA
(EUCTR)
09/06/2021Open-label, single-arm, multicenter study in Japanese patients with aplastic anemiaA 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.NULLNAFemale: yes
Male: yes
Phase 3Japan