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

  
91 trials found
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PhaseCountries
1NCT05323617
(ClinicalTrials.gov)
May 15, 20235/4/2022Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive TherapyTwo 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 ISTSevere Aplastic Anemia (SAA)Drug: Romiplostim;Drug: Antithymocyte Globulin;Drug: Cyclosporine AAmgenNULLNot yet recruiting18 YearsN/AAll40Phase 2NULL
2NCT05660785
(ClinicalTrials.gov)
December 1, 202223/11/2022Herombopag Added to Cyclosporine in Non Severe Aplastic AnemiaThe Efficacy and Safety of Herombopag Combined With Cyclosporine for Patients With Non Severe Aplastic AnemiaNon Severe Aplastic Anemia;UntreatedDrug: HerombopagInstitute of Hematology & Blood Diseases HospitalJiangsu Hengrui Pharmaceuticals Co.,LtdRecruiting18 YearsN/AAll54Phase 2China
3NCT05720234
(ClinicalTrials.gov)
November 10, 202211/1/2023Avatrombopag Combined With IST as First-line Treatment for SAAThe Efficacy and Safety Study of Avatrombopag Combined With IST as First-line Treatment for Severe Aplastic Anemia, A Single-arm, Phase II Clinical StudySevere Aplastic AnemiaDrug: avatrombopagInstitute of Hematology & Blood Diseases HospitalNULLRecruiting12 Years60 YearsAll53Phase 2China
4NCT05399732
(ClinicalTrials.gov)
July 202224/5/2022Efficacy and Safety in Transfusion Independent Non-severe Aplastic AnemiaA Randomized, Case Controlled Clinical Trial Evaluating the Efficiency and Safety of Luspatercept Plus Ciclosporin Versus Ciclosporin in Newly Diagnosed Transfusion Independent Non-severe Aplastic Anemia (NSAA).Aplastic AnemiaDrug: LuspaterceptBing HanNULLNot yet recruiting18 Years80 YearsAll90Phase 2China
5NCT05571332
(ClinicalTrials.gov)
June 28, 202228/8/2022Efficacy and Safety of Avatrombopag Combined With IST for the Treatment of HAAA and SAA With Abnormal Liver FunctionEfficacy and Safety of Avatrombopag Combined With IST for the Treatment of HAAA and SAA With Abnormal Liver FunctionAplastic AnemiaDrug: Avatrombopag 20 MG Oral TabletInstitute of Hematology & Blood Diseases HospitalNULLRecruiting18 Years70 YearsAll39N/AChina
6ChiCTR2200060098
2022-05-052022-05-18A retrospective study to assess the efficacy and safety of eltrombopag in combination with immunosuppressants in treatment-naive patients with SAAA retrospective study to assess the efficacy and safety of eltrombopag in combination with immunosuppressants in treatment-naive patients with SAA Aplastic anemiaExperimental group:Eltrombopag combined with immunosuppressive therapy (IST);Control group:IST;The First Affiliated Hospital of Zhejiang University of Traditional Chinese MedicineNULLPending1680BothExperimental group:132;Control group:66;Phase 4China
7NCT05333861
(ClinicalTrials.gov)
May 1, 202211/4/2022An Observational, Multicenter Study to Evaluate the Safety and Effectiveness of Hetrombopag in Patients With ITP or AAAn Observational, Multicenter Study to Evaluate the Safety and Effectiveness of Hetrombopag in Patients With ITP or AAPrimary Immune Thrombocytopenia;Aplastic AnemiaDrug: hetrombopagWuhan Union Hospital, ChinaJiangsu Hengrui Pharmaceutical Co., Ltd.Not yet recruitingN/AN/AAll1150China
8ChiCTR2100054957
2021-12-242021-12-29A prospective controlled study evaluating the efficacy and safety of eltrombopag combined with immunosuppressive agents in treatment-na?ve patients with SAAA prospective controlled study evaluating the efficacy and safety of eltrombopag combined with immunosuppressive agents in treatment-na?ve patients with SAA Aplastic anemia (AA)Group 1:Eltrombopag + Immunosuppressive Therapy (IST);Group 2: Immunosuppressive Therapy (IST);The First Affiliated Hospital of Zhejiang Medical UniversityNULLRecruiting1680BothGroup 1:132;Group 2:66;Phase 4China
9ChiCTR2100051874
2021-10-012021-10-08Efficacy and safety of ruxolitinib in preventing aGVHD after haplotype bone marrow transplantation in severe aplastic anemiaEfficacy and safety of ruxolitinib in preventing aGVHD after haplotype bone marrow transplantation in severe aplastic anemia Severe aplastic anemiaexperimental group:ruxolitinib;The Second Affiliated Hospital of Dalian Medical UniversityNULLRecruiting160Bothexperimental group:20;N/AChina
10NCT05018936
(ClinicalTrials.gov)
October 1, 202119/8/2021Efficacy and Safety of Hetrombopag in Non-severe Aplastic AnemiaEfficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia: a Prospective Single Arm StudyAplastic Anemia;Drug EffectDrug: HetrombopagPeking Union Medical College HospitalNULLNot yet recruiting18 Years75 YearsAll40Phase 2/Phase 3China
11ChiCTR2100050948
2021-09-102021-09-08Comparison of clinical efficacy and safety of hematopoietic stem cell transplantation and immunosuppression in the treatment of hepatitis-related aplastic anemia: a single-center cohort studyComparison of clinical efficacy and safety of hematopoietic stem cell transplantation and immunosuppressive therapy in patients with hepatitis-related aplastic anemia Hepatitis-associated Aplastic Anemiaematopoietic stem cell transplantation group:Nil;ATG combined with cyclosporine group :Nil;Zhejiang Provincial Hospital of Traditional Chinese MedicineNULLRecruiting150Bothematopoietic stem cell transplantation group:30;ATG combined with cyclosporine group :30;China
12ChiCTR2100050045
2021-09-012021-08-16A Study to Assess the Safety and Efficacy of Avatrombopag in Chinese Patients with Aplastic AnemiaA Non-randomized, Open-label, Phase II Study to Assess the Safety and Efficacy of Avatrombopag in Chinese Patients With Aplastic Anemia aplastic anemiaGroup 1:Avatrombopag treatment;Tianjin Medical University, General HospitialNULLPending1675BothGroup 1:60;Phase 4China
13ChiCTR2100047288
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
14ChiCTR2100045322
2021-06-012021-04-12Efficacy and safety of umbilical cord mesenchymal stem cells combined with standard immunosuppressive agents in the treatment of children with acquired severe aplastic anemia: a randomized, controlled clinical studyEfficacy and safety of umbilical cord mesenchymal stem cells combined with standard immunosuppressive agents in the treatment of children with acquired severe aplastic anemia: a randomized, controlled clinical study pediatric acquired severe aplastic anemiaExperimental group:Anti-thymocyte globulin+Ciclosporin A+Mesenchymal stem cell;Control group:Anti-thymocyte globulin+Ciclosporin A;Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical SciencesNULLRecruiting116BothExperimental group:32;Control group:32;China
15ChiCTR2100043229
2021-02-222021-02-09A Single-Center, Single-Arm, Phase II Clinical Study of the Efficacy and Safety of Cyclosporine Combined with Eltrombopag Olamine Tablets in Treatment-Naive Transfusion-Dependent Non-Severe Aplastic AnemiaA Single-Center, Single-Arm, Phase II Clinical Study of the Efficacy and Safety of Cyclosporine Combined with Eltrombopag Olamine Tablets in Treatment-Naive Transfusion-Dependent Non-Severe Aplastic Anemia Aplastic anemiaDurgs Group:Elrombopag combined with Cyclosporine;Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesNULLRecruiting1885BothDurgs Group:61;Phase 2China
16NCT04728789
(ClinicalTrials.gov)
February 1, 20211/12/2020Avatrombopag Usage in NSAAEfficacy and Safety of Avatrombopag in Non-severe Aplastic Anemia - a Multicenter Prospective Single Arm StudyAplastic Anemia;Drug EffectDrug: Avatrombopag 20 MGPeking Union Medical College HospitalNULLNot yet recruiting18 Years75 YearsAll40Phase 2/Phase 3China
17NCT04409080
(ClinicalTrials.gov)
January 13, 202126/5/2020REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive TherapyA Phase 1/2 Study of REGN7257 (Anti-Interleukin 2 Receptor Subunit Gamma [IL2RG] Monoclonal Antibody) in Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive TherapySevere Aplastic Anemia (SAA)Drug: REGN7257Regeneron PharmaceuticalsNULLRecruiting18 YearsN/AAll57Phase 1/Phase 2United States;France;Korea, Republic of;United Kingdom
18NCT04328727
(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
19NCT04439006
(ClinicalTrials.gov)
October 23, 202017/6/2020Ibrutinib for the Treatment of COVID-19 in Patients Requiring HospitalizationRandomized Double-Blind Phase 2 Trial of Ibrutinib Versus Standard Treatment for COVID-19 Illness Requiring Hospitalization With Safety Lead-InAplastic Anemia;Hematopoietic and Lymphoid Cell Neoplasm;Malignant Solid Neoplasm;Monoclonal B-Cell Lymphocytosis;Monoclonal Gammopathy of Undetermined Significance;Myelodysplastic Syndrome;Symptomatic COVID-19 Infection Laboratory-ConfirmedOther: Best Practice;Drug: IbrutinibJennifer WoyachJanssen Scientific Affairs, LLCActive, not recruiting18 YearsN/AAll10Phase 2United States
20NCT05088642
(ClinicalTrials.gov)
September 28, 202012/10/2021A Trial of Hetrombopag in Healthy and Hepatic Impairment SubjectsA Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Hetrombopag Olamine Tablets in Subjects With Mild Hepatic Impairment (Child-Pugh Class A), Moderate Hepatic Impairment (Child-Pugh Class B), and Normal Hepatic FunctionSever Aplastic AnaemiaDrug: Hetrombopag Olamine TabletJiangsu HengRui Medicine Co., Ltd.NULLCompleted18 Years65 YearsAll24Phase 1China
21NCT04478227
(ClinicalTrials.gov)
August 18, 202010/7/2020TPO-Mimetic Use in Children for Hematopoietic FailureSingle Arm Prospective Open Label Pilot Study Evaluating Short-Term Safety and Efficacy of Romiplostim in Children With Inherited and Acquired Disorders of Hematopoietic FailureBone Marrow Failure Disorders;Aplastic Anemia;Thrombocytopenia;Refractory Cytopenia of Childhood;Myelodysplastic Syndrome(MDS)Drug: RomiplostimAnjali SharathkumarAmgenRecruiting0 Years21 YearsAll25Early Phase 1United States
22NCT04350606
(ClinicalTrials.gov)
July 25, 20201/4/2020A Study to Assess Efficacy and Safety of PF-06462700 in Japanese Participants With Aplastic AnemiaA MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS 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 ANEMIAAplastic AnemiaBiological: PF-06462700PfizerNULLCompleted2 YearsN/AAll3Phase 3Japan
23NCT04403321
(ClinicalTrials.gov)
July 1, 202021/5/2020Efficacy and Safety of Eltrombopag + Tacrolimus in Chinese Refractory or Relapsed Aplastic Anemia PatientsEfficacy and Safety of Eltrombopag + Tacrolimus in Chinese Refractory or Relapsed Aplastic Anemia PatientsAplastic Anemia;Drug EffectDrug: Tacrolimus;Drug: Placebo (for Tacrolimus)Peking Union Medical College HospitalNULLCompleted14 Years85 YearsAll114Phase 2China
24NCT04304820
(ClinicalTrials.gov)
May 7, 202010/3/2020Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)Severe Aplastic AnemiaDrug: Eltrombopag;Drug: Cyclosporine;Drug: Horse-Anti-thymocyte-GlobulinNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting3 YearsN/AAll39Phase 2United States
25NCT03988608
(ClinicalTrials.gov)
December 9, 201913/6/2019Study to Assess the Safety and Efficacy of Eltrombopag in Chinese Refractory or Relapsed Severe Aplastic Anemia (SAA) Subjects.A Non-randomized, Open-label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Chinese Subjects With Refractory or Relapsed Severe Aplastic AnemiaAplastic AnemiaDrug: Eltrombopag 25 mgNovartis PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll20Phase 2China
26JPRN-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
27NCT03896971
(ClinicalTrials.gov)
November 15, 201921/3/2019Combination of Thrombopoietin Mimetic and Immunosuppressive Therapy in Aplastic AnaemiaTreatment With Thrombopoietin Mimetic Plus Immunosuppressive Therapy in Egyptian Patients With Aplastic AnaemiaAplastic AnemiaDrug: Combination of thrombopoietin mimetic and cyclosporin ASafaa AA KhaledAssiut UniversityCompleted16 Years65 YearsAll66Phase 4Egypt
28EUCTR2016-002814-29-IT
(EUCTR)
14/06/201924/05/2021SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemiaSOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR First-line severe aplastic anaemia
MedDRA version: 20.0;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: SANDIMMUN NEORAL - 10 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral ]
INN or Proposed INN: 00070500
Other descriptive name: CICLOSPORINA
Trade Name: SANDIMMUN NEORAL - 25 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Other descriptive name: CICLOSPORINA
Trade Name: SANDIMMUN NEORAL - 50 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Trade Name: SANDIMMUN NEORAL - 100 MG CAPSULE MOLLI 30 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Trade Name: REVOLADE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU) 28 COMPRESSE
Product Name: Eltrombopag
Product Code: [ETB115]
INN or Proposed INN: 00319301
Other descriptive name: Eltrombopag
Trade Name: REVOLADE - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Hungary;Hong Kong;Mexico;Spain;Thailand;Brazil;Korea, Democratic People's Republic of;Turkey;Netherlands;Italy;India
29EUCTR2015-003166-91-GB
(EUCTR)
22/05/201905/07/2017A phase II dose escalation study: use of eltrombopag in pediatric patientswith 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 naïve severe aplastic anemia or recurrent aplastic anemia. Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA)
MedDRA version: 20.0;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
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom
30NCT03520647
(ClinicalTrials.gov)
February 19, 20199/5/2018Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD ProphylaxisHaplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD ProphylaxisSevere Aplastic Anemia (SAA);Hypo-Plastic Myelodysplastic Syndrome (MDS);Paroxysmal Nocturnal Hemoglobinuria (PNH)Drug: Cyclophosphamide;Other: Peripheral Blood Stem CellsNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting4 Years75 YearsAll56Phase 2United States
31ChiCTR1800019669
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
32NCT03821987
(ClinicalTrials.gov)
December 17, 201823/1/2019Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAARisk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAAAplastic Anemia;Stem Cell Transplant Complications;Engraft FailureDrug: FludarabinePeking University People's HospitalNULLRecruiting3 Years55 YearsAll55N/AChina
33EUCTR2015-003166-91-NL
(EUCTR)
14/11/201808/08/2017A phase II dose escalation study: use of eltrombopag in pediatric patients with 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 naïve severe aplastic anemia or recurrent aplastic anemia. Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA)
MedDRA version: 20.0;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
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Portugal;United States;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom
34JPRN-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
35EUCTR2015-003166-91-PT
(EUCTR)
15/12/201713/07/2017A phase II dose-escalation study characterizing the PK of eltrombopag in pediatric patients with previously untreated or relapsed severe aplastic anemia or recurrent aplastic anemia.A 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 naïve severe aplastic anemia or recurrent aplastic anemia. Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA)
MedDRA version: 20.0;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
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom
36ChiCTR-IOR-17012957
2017-10-312017-10-12A single Central, open, parallel control study to evaluate the safety and effectiveness of Arsenious Acid- Immunological preparationsand Immunological preparations in aplastic anemia (AA)A single Central, open, parallel control study to evaluate the safety and effectiveness of Arsenious Acid- Immunological preparationsand Immunological preparations in aplastic anemia (AA) aplastic anemiaA:ATO+CsA;B:CsA;Henan Province Cancer HospitalNULLPending1865BothA:100;B:100;China
37EUCTR2016-002814-29-HU
(EUCTR)
07/09/201705/07/2017SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months.SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR First-line severe aplastic anaemia
MedDRA version: 20.0;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
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Hong Kong;Hungary;Mexico;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India
38EUCTR2016-002814-29-NL
(EUCTR)
21/07/201729/03/2017SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia with follow-up up to 24-months.SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR First-line severe aplastic anaemia
MedDRA version: 20.0;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
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Hungary;Hong Kong;Mexico;Thailand;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India
39ChiCTR-IOR-17011653
2017-07-012017-06-14A prospective, randomized, controlled clinical study of non transfusion dependent non severe aplastic anemia treated with cyclosporine, androgen and levamisole hydrochlorideA prospective, randomized, controlled clinical study of non transfusion dependent non severe aplastic anemia treated with cyclosporine, androgen and levamisole hydrochloride Aplastic anemiaSA group:none;LSA group:levamisole hydrochloride;The First affiliated Hospital of Zhejiang Chinese Medical UniversityNULLPending1870BothSA group:124;LSA group:124;China
40EUCTR2016-002814-29-ES
(EUCTR)
21/03/201716/12/2016SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months.SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR First-line severe aplastic anaemia
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
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Novartis Farmacéutica, S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Qatar;Hong Kong;Spain;Turkey;Italy;India;France;Hungary;Mexico;Canada;Brazil;Netherlands;Korea, Republic of
41NCT03055078
(ClinicalTrials.gov)
January 20174/2/2017Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic AnemiaEvaluation of Safety and Efficacy in Patients With Aplastic Anemia by Transplantation of Umbilical Cord Derived Mesenchymal Stem CellsAplastic AnemiaBiological: mesenchymal stem cellsHebei Medical UniversityNULLRecruiting14 Years60 YearsAll10Phase 1China
42NCT02857530
(ClinicalTrials.gov)
August 201626/7/2016Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic AnemiaEfficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic AnemiaAnemia, AplasticDrug: rhTPO;Drug: placeboTianjin Medical University General HospitalNULLNot yet recruiting6 Years60 YearsBoth250Phase 2China
43NCT01861093
(ClinicalTrials.gov)
October 16, 201521/5/2013Safety Study of Cord Blood Units for Stem Cell TransplantsA Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult PatientsAplastic Anemia;Leukemia;Myelodysplastic Syndrome (MDS);LymphomaBiological: Cord Blood UnitsNational Heart, Lung, and Blood Institute (NHLBI)National Cancer Institute (NCI);National Institute of Allergy and Infectious Diseases (NIAID);National Cord Blood Program, New York Blood CenterRecruiting4 YearsN/AAll500Phase 2United States
44NCT02462252
(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
45NCT02099747
(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
46EUCTR2014-000174-19-DE
(EUCTR)
27/01/201501/09/2014Efficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopag with Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin AEfficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopagwith Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A - EMAA Moderate Aplastic Anemia (MAA);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Trade Name: Revolade 75 mg
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: Eltrombopag
Other descriptive name: ELTROMBOPAG OLAMINE
Universitätsklinikum UlmNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2;Phase 3France;Germany;Switzerland
47NCT02773225
(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
48NCT02407470
(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
49NCT02148133
(ClinicalTrials.gov)
July 23, 201422/5/2014A Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic AnemiaA Non-randomized, Open-label, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic AnemiaCytopaeniaDrug: Eltrombopag 12.5 mg;Drug: Eltrombopag 25 mgNovartis PharmaceuticalsNULLCompleted18 Years79 YearsAll21Phase 2Japan
50NCT01818726
(ClinicalTrials.gov)
June 23, 20145/3/2013Safety and Efficacy of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia PatientsOpen-label Study of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia Patients Undergoing Treatment Programs in Comparison With Control GroupAplastic AnemiaDrug: ICL670;Drug: Chelation;Drug: No chelationNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll15Phase 4Russian Federation
51NCT02094417
(ClinicalTrials.gov)
April 14, 201418/3/2014A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic AnemiaA Phase 2, Randomized, Open-Label, Parallel, Comparative, Dose-Finding Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia Subjects With Thrombocytopenia Refractory to Immunosuppressive TherapyAplastic AnemiaDrug: AMG531Kyowa Kirin Korea Co., Ltd.NULLCompleted19 YearsN/AAll35Phase 2Korea, Republic of
52NCT02055456
(ClinicalTrials.gov)
February 20143/2/2014Nandrolone Decanoate in the Treatment of TelomeropathiesMale Hormones for Telomere Related DiseasesAplastic Anemia;Bone Marrow Failure Syndromes;Idiopathic Pulmonary Fibrosis;Telomere ShorteningDrug: Nandrolone DecanoateUniversity of Sao PauloConselho Nacional de Desenvolvimento Científico e TecnológicoRecruiting2 YearsN/ABoth20Phase 1/Phase 2Brazil
53NCT02007811
(ClinicalTrials.gov)
November 201321/11/2013Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single VaccinationProspective, Open-label, Multicentre Clinical Trial, Phase I/IIa, to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates CD3+-Depleted, CD19+-Enriched, Cryopreserved (Single Administration After Day 120 Following Allogeneic Stem Cell Transplantation (SCT), Donor-identical) in 4 Groups With Escalating Doses for Immune Response Enhancement, Measured as Response to a Antedated Single VaccinationAcute Myeloid Leukemia;Acute Lymphoblastic Leukemia;Chronic Myeloid Leukemia;Non Hodgkin's Lymphoma;Hodgkin's Disease;Myelodysplastic Syndrome;Multiple Myeloma;Aplastic AnemiaBiological: allogeneic donor derived B-lymphocytesUniversity of Erlangen-Nürnberg Medical SchoolUniversity Hospital Regensburg;Wuerzburg University Hospital;University Hospital, Essen;German Research FoundationRecruiting18 Years75 YearsBoth15Phase 1/Phase 2Germany
54NCT02218437
(ClinicalTrials.gov)
October 20136/8/2014Treatment Protocol of Child SAA With the Injection of Mesenchymal Stem Cells(Umbilical Cord Derived)Child With Severe Aplastic Anemia (SAA) Therapy: the Injection of Umbilical Cord Derived Mesenchymal Stem Cells.Complications of Organ Transplant Stem Cells Umbilical CordDrug: MSC+ATGChinese Academy of Medical SciencesNULLRecruiting1 Month18 YearsBoth20Phase 4China
55NCT01891994
(ClinicalTrials.gov)
June 28, 201328/6/2013Extended Dosing With Eltrombopag for Severe Aplastic AnemiaExtended Dosing With Eltrombopag in Refractory Severe Aplastic AnemiaSevere Aplastic Anemia (SAA)Drug: EltrombopagNational Heart, Lung, and Blood Institute (NHLBI)NULLActive, not recruiting2 Years100 YearsAll40Phase 2United States
56ChiCTR-PRC-13003130
2013-04-012013-03-30Voriconazole tablet for primary prophylaxis of invasive fungal infection in patients with severe aplastic anemia: a prospective, randomized, controlled, multi-center trialThe efficacy and pharmacoeconimics of voriconazole tablet for primary prophylaxis of invasive fungal infection in patients with severe aplastic anemia Severe Aplastic Anemia (SAA)Trial group:Vfend? (Voriconazole tablet for oral) should be administered 6mg/kg at the first day for adults, and then 200mg, twice daily; 4-7mg/kg/d for children, divided into twice a day,with administration period no longer than 6 weeks.;control:without anti-fungal drug;Institute of Hematology & Blood Diseases Hospital, CAMS & PUMCNULLCompleted365BothTrial group:50;control:50;China
57NCT01586455
(ClinicalTrials.gov)
April 201325/4/2012Human Placental-Derived Stem Cell TransplantationA Single-Arm Study to Assess the Safety of Transplantation With Human Placental-Derived Stem-Cells Combined With Unrelated and Related Cord Blood in Subjects With Certain Malignant Hematologic Diseases and Non-Malignant DisordersMucopolysaccharidosis I;Mucopolysaccharidosis VI;Adrenoleukodystrophy;Niemann-Pick Disease;Metachromatic Leukodystrophy;Wolman Disease;Krabbe's Disease;Gaucher's Disease;Fucosidosis;Batten Disease;Severe Aplastic Anemia;Diamond-Blackfan Anemia;Amegakaryocytic Thrombocytopenia;Myelodysplastic Syndrome;Acute Myelogenous Leukemia;Acute Lymphocytic LeukemiaDrug: Human Placental Derived Stem CellNew York Medical CollegeNULLCompleted0 Years55 YearsAll43Phase 1United States
58NCT01760096
(ClinicalTrials.gov)
January 20131/1/2013Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)Paroxysmal Nocturnal Hemoglobinuria;Hemoglobinuria;Hemoglobinuria, Paroxysmal;Proteinuria;Urination Disorders;Thrombosis;Bone Marrow Failure;Aplastic Anemia,;Anemia, HemolyticDrug: Levamisole+cyclosporin A+Glucocorticoids;Drug: cyclosporin A+Glucocorticoids;Drug: GlucocorticoidsInstitute of Hematology & Blood Diseases HospitalNULLActive, not recruiting18 YearsN/ABoth50Phase 2China
59NCT01703169
(ClinicalTrials.gov)
November 201227/9/2012Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic AnemiaEfficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic AnemiaSevere Aplastic Anemia;Very Severe Aplastic Anemia;Moderate Aplastic AnemiaDrug: EltrombopagUniversity of UtahNovartisCompleted18 YearsN/AAll13Phase 2United States
60NCT01642979
(ClinicalTrials.gov)
July 201214/7/2012Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal HemoglobinuriaPhase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal HemoglobinuriaParoxysmal Nocturnal Hemoglobinuria;Hemoglobinuria;Hemoglobinuria, Paroxysmal;Proteinuria;Urination Disorders;Thrombosis;Bone Marrow Failure;Aplastic Anemia,;Anemia, HemolyticDrug: Levamisole+cyclosporin A+Glucocorticoids;Drug: cyclosporin A+Glucocorticoids;Drug: GlucocorticoidsInstitute of Hematology & Blood Diseases HospitalNULLActive, not recruiting18 YearsN/ABoth120Phase 2China
61NCT01844635
(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
62NCT01472055
(ClinicalTrials.gov)
October 20116/11/2011Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell TransplantationPharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell TransplantationAcute Leukemia;Chronic Leukemia;Severe Aplastic AnemiaDrug: FludarabineSeoul National University HospitalMinistry of Food and Drug Safety, KoreaRecruitingN/A19 YearsBoth46Phase 2Korea, Republic of
63NCT01546415
(ClinicalTrials.gov)
October 201110/11/2011Safety and Efficacy of Desferasirox in Chinese Patients With Iron Overload and Aplastic AnemiaA Single Arm, Multicenter, Open Label Study of Desferasirox in Chinese Patients With Iron Overload and Aplastic AnemiaIron OverloadDrug: DesferasiroxNovartis PharmaceuticalsNULLCompleted18 YearsN/ABoth64Phase 4China
64JPRN-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
65NCT01343680
(ClinicalTrials.gov)
April 201127/4/2011Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology PatientsA Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, CanadaChildhood Cancer;Aplastic Anemia;Metabolic DisordersDrug: Heparin;Drug: Normal salineAlberta Children's HospitalStollery Children's HospitalTerminatedN/A17 YearsBoth2Phase 3Canada
66NCT01297972
(ClinicalTrials.gov)
February 201116/2/2011Mesenchymal Stem Cells in the Treatment of Relapsed/Refractory Severe Acquired Aplastic AnemiaBone Marrow Mesenchymal Stem Cells in the Treatment of Refractory Severe Acquired Aplastic AnemiaAplastic AnemiaBiological: Intravenous bone marrow mesenchymal stem cells infusionUniversity of Sao PauloNULLCompleted18 Years65 YearsBoth9Phase 1/Phase 2Brazil
67JPRN-UMIN000004264
2010/11/0101/11/2010A Pharmacokinetics (PK)/Phase I study of intravenous (i.v.) administration of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-SCT)A Pharmacokinetics (PK)/Phase I study of intravenous (i.v.) administration of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-SCT) - A PK/Phase I study of i.v. MMF for GVHD prophylaxis Refractory hematologic disorders, including1. Acute myelogenous leukemia2. Acute lymphoblastic leukemia3. Myelodysplastic syndrome4. Chronic myelogenous leukemia5. Malignant lymphoma6. Aplastic anemiaFor GVHD prophylaxis, MMF is administered 4-6 h after allo-SCT at a dose of 1000 mg i.v. (diluted to a concentration of 6 mg/ml using 5% Dextrose, over 2 h) thrice daily (or twice daily in the case of cord blood transplantation) from day 0 to day 10 (for up to 14 days). Thereafter, patients are changed to p.o. MMF at the same dose and interval. After day 31, the dose tapers depending on individual risk factors for GVHD.
Blood samples (2 ml) for PK analysis are collected in EDTA tubes at 0, 0.5, 1, 2, 4, 8, and 12 h after the morning dose on days 2 and 9 during i.v. MMF administration and at 0, 1, 2, 4, 8, and 12 h on day 16 during p.o. MMF administration.
Total mycophenolic acid (MPA) levels are quantified by reverse-phase HPLC.
After quantification, non-compartmental analyses of total MPA concentration time data are conducted to estimate the AUC.
Kobe University Graduate School of MedicineSchool of Pharmacy and Pharmaceutical Science, Mukogawa Women's UniversityComplete: follow-up complete15years-old69years-oldMale and Female10Phase 1Japan
68EUCTR2008-005594-35-BE
(EUCTR)
28/10/200906/08/2009Randomized double-blind study of mesenchymal stem cells (MSC) in patients undergoing matched unrelated allogeneic bone marrow or peripheral blood stem cell transplantation- A European multicentre study. - NARandomized double-blind study of mesenchymal stem cells (MSC) in patients undergoing matched unrelated allogeneic bone marrow or peripheral blood stem cell transplantation- A European multicentre study. - NA Hematological disorders of the following types:ALL: acute lymphoblastic leukemia in complete remission (<5% blasts in marrow) up to and including third remission (excluding relapse).AML: acute myelocytic leukemia in remission (excluding relapse).CML: chronic myelocytic leukemia who are in the chronic phase of the disease.Severe aplastic anemia, hemoglobinopathies (thalassemia major).Inborn errors of metabolism.Myelodysplastic syndromes
MedDRA version: 9.1;Level: LLT;Classification code 10027703;Term: Mismatched donor bone marrow transplantation therapy
Product Name: Mesenchymal stem cells
Product Code: MSC
CHU Sart-TilmanNULLNot RecruitingFemale: yes
Male: yes
172Phase 3Belgium
69NCT00882323
(ClinicalTrials.gov)
November 200815/4/2009Reduced 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 AnemiaAplastic AnemiaDrug: Cyclophosphamide, Fludarabine, ThymoglobulinThe Korean Society of Pediatric Hematology OncologyNULLRecruiting1 Year21 YearsBoth33Phase 2Korea, Republic of
70NCT00471848
(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
71NCT00604201
(ClinicalTrials.gov)
May 21, 20088/1/2008Stem Cell Transplant Using Peripheral and Cord Blood Stem Cells to Treat Severe Aplastic Anemia and Myelodysplastic SyndromeCo-Infusion of Umbilical Cord Blood and Haploidentical CD34+ Cells Following Nonmyeloablative Conditioning as Treatment for Severe Aplastic Anemia and MDS Associated With Severe Neutropenia Refractory to Immunosuppressive TherapyMyelodysplastic Syndrome (MDS) With Refractory Anemia (RA);Severe Aplastic Anemia (SAA)Biological: Umbilical Cord BloodNational Heart, Lung, and Blood Institute (NHLBI)NULLActive, not recruiting4 Years75 YearsAll31Phase 2United States
72NCT00455312
(ClinicalTrials.gov)
August 200730/3/2007Stem Cell Transplant (SCT) for Dyskeratosis Congenita or SAAHematopoietic Stem Cell Transplant For Patients With Dyskeratosis Congenita and Severe Aplastic AnemiaDyskeratosis Congenita;Aplastic AnemiaDrug: Campath 1H;Drug: Cyclophosphamide;Drug: Fludarabine;Procedure: Total Body Irradiation;Procedure: Stem Cell Transplantation;Drug: antithymocyte globulin;Drug: MethylprednisoloneMasonic Cancer Center, University of MinnesotaNULLCompletedN/A70 YearsAll36Phase 2/Phase 3United States
73NCT00673114
(ClinicalTrials.gov)
August 200727/12/2007Unrelated Cord Blood Transplant Plus a Haplo-Identical (Half-Matched), T-Cell Depleted Stem Transplant From a Related Donor for Subjects With High Risk MalignanciesA Prospective, Phase I/II Trial Determining the Efficacy and Safety of Allogeneic Hematopoietic Stem Cell Transplantation Using Banked Unrelated Umbilical Cord Blood Supplemented With Related, Haplo-Identical T-Cell Depleted Stem Cells in Subjects With High Risk MalignanciesHematologic Malignancy;Myelodysplastic Syndrome (MDS);Aplastic AnemiaBiological: haplo/cord transplantJoanne Kurtzberg, MDMiltenyi Biotec GmbHCompletedN/A55 YearsAll3Phase 1/Phase 2United States
74EUCTR2006-006577-25-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
75EUCTR2008-001151-22-IT
(EUCTR)
06/06/200714/06/2011ALEMTUZUMAB AND LOW-DOSE CYCLOSPORINE-A AS ALTERNATIVE IMMUNOSUPPRESSIVE TREATMENT FOR SEVERE APLASTIC ANEMIA (SAA) AND SINGLE-LINEAGE APLASTIC PATIENTS. - AlesaaALEMTUZUMAB AND LOW-DOSE CYCLOSPORINE-A AS ALTERNATIVE IMMUNOSUPPRESSIVE TREATMENT FOR SEVERE APLASTIC ANEMIA (SAA) AND SINGLE-LINEAGE APLASTIC PATIENTS. - Alesaa Aplastic anemia and single-lineage bone marrow failure
MedDRA version: 13.1;Level: PT;Classification code 10002965;Term: Aplasia pure red cell;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 13.1;Level: LLT;Classification code 10047350;Term: Very few granulocyte precursors;Classification code 10002967;Term: Aplastic anaemia;Classification code 10001507;Term: Agranulocytosis;System Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: MABCAMPATH
INN or Proposed INN: Alemtuzumab
UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO IINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Italy
76NCT00895739
(ClinicalTrials.gov)
June 20067/5/2009Alemtuzumab and Low-Dose Cyclosporine in Treating Patients With Severe Aplastic Anemia or Acquired Marrow FailureAlemtuzumab and Low-Dose Cyclosporine-A as Alternative Immunosuppressive Treatment for Severe Aplastic Anemia (SAA) and Single-Lineage Aplastic PatientsNonmalignant NeoplasmBiological: alemtuzumab;Drug: cyclosporineFederico II UniversityNULLRecruiting18 YearsN/ABoth50Phase 2Italy
77NCT00737685
(ClinicalTrials.gov)
January 200618/8/2008Flu+CPM+rATG Conditioning Regimes for Unrelated Bone Marrow Transplantation (UBMT)(or Mobilized Peripheral Blood)in Severe Aplastic Anemia (SAA)Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Bone Marrow (or Mobilized Peripheral Blood) Transplantation in Severe Aplastic AnemiaAnemia, AplasticDrug: cyclophosphamide, fludarabine , thymoglobulinThe Korean Society of Pediatric Hematology OncologyNULLActive, not recruitingN/A25 YearsBoth30Phase 2Korea, Republic of
78NCT00438178
(ClinicalTrials.gov)
October 200521/2/2007Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological MalignanciesA Phase I Study of Obatoclax Mesylate (GX15-070MS) in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML)in Myeloid Blast Phase, Myelofibrosis, Previously-Treated Chronic Lymphocytic Leukemia (CLL), or Aplastic AnemiaHematological MalignanciesDrug: Obatoclax mesylate (GX15-070MS)Gemin XNULLCompleted18 YearsN/ABoth44Phase 1United States;Canada
79NCT00806598
(ClinicalTrials.gov)
May 20059/12/2008Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic SyndromePhase II Study of Combination of Thymoglobulin, Cyclosporine, Methylprednisone, and Granulocyte Colony-stimulating Factor (GCSF) in Patients With Newly Diagnosed Aplastic Anemia or With Hypoplastic or Low/Intermediate-1 Risk Myelodysplastic SyndromeMyelodysplastic Syndrome;Aplastic AnemiaDrug: Thymoglobulin;Drug: Cyclosporine;Drug: Methylprednisolone;Drug: G-CSFM.D. Anderson Cancer CenterGenzyme, a Sanofi CompanyCompleted15 YearsN/AAll53Phase 2United States
80NCT00295997
(ClinicalTrials.gov)
May 200523/2/2006Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic AnemiaNon-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic AnemiaChronic Myeloproliferative Disorders;Kidney Cancer;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative NeoplasmsBiological: anti-thymocyte globulin;Biological: filgrastim;Biological: graft-versus-tumor induction therapy;Biological: therapeutic allogeneic lymphocytes;Drug: busulfan;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methotrexate;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationUniversity of California, San FranciscoNational Cancer Institute (NCI)Active, not recruitingN/A74 YearsBoth35N/AUnited States
81NCT01231841
(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
82JPRN-C000000356
2004/12/0120/03/2006Evaluation of the safety and efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) using alemtuzumab for patients with aplastic anemiaEvaluation of the safety and efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) using alemtuzumab for patients with aplastic anemia - HSCT for aplastic anemia using alemtuzumab Aplastic anemiaAlemtuzumab is added to the fludarabine-based regimen at 0.16 – 0.25 mg/kg per day for 6 days (days -10 to -5).GCP-ISS HE0403 groupNULLComplete: follow-up complete20years-old65years-oldMale and Female38Phase 1,2Japan
83NCT00516152
(ClinicalTrials.gov)
November 200213/8/2007Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCTPhase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell TransplantationChronic Myeloid Leukemia;Acute Myelogenous Leukemia;Myelodysplasia;Acute Lymphocytic Leukemia;Severe Aplastic Anemia;Non-Hodgkin's Lymphoma;Lymphoproliferative Disease;Multiple Myeloma;Advanced Myeloproliferative DiseaseDrug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSFUniversity of California, San FranciscoNULLCompleted15 Years61 YearsBoth36Phase 2United States
84NCT00399971
(ClinicalTrials.gov)
November 200214/11/2006Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic AnemiaPhase I/II Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic AnemiaAnemia, AplasticProcedure: Ex Vivo Immunotherapy;Drug: Ex vivo immunotherapyShenzhen Zhongxing Yangfan Biotech Co. Ltd.The 12th Guangzhou Municipal Hospital;Liu Hua Qiao HospitalRecruiting10 Years80 YearsBoth100Phase 1/Phase 2China
85NCT00053157
(ClinicalTrials.gov)
June 200227/1/2003Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic AnemiaUse Of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) To Mobilize Donor Peripheral Blood Stem Cells Along With GM-CSF Administration Post Allogeneic Transplant - A Pilot StudyChronic Myeloproliferative Disorders;Graft Versus Host Disease;Leukemia;Lymphoma;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative NeoplasmsBiological: sargramostimRoswell Park Cancer InstituteNULLCompleted5 Years60 YearsAll10N/AUnited States
86NCT00578903
(ClinicalTrials.gov)
February 200219/12/2007Allogeneic Stem Cell Transplant for Patients With Severe Aplastic AnemiaAllogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors (SAA MUD)Aplastic AnemiaDrug: Cytoxan;Drug: Campath;Radiation: Total Body Irradiation (TBI);Drug: FK-506;Drug: Methotrexate;Procedure: Stem cell infusionBaylor College of MedicineThe Methodist Hospital System;Texas Children's Hospital;Center for Cell and Gene Therapy, Baylor College of MedicineTerminatedN/A60 YearsAll22Phase 2United States
87NCT00053989
(ClinicalTrials.gov)
January 29, 20025/2/2003NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/DisordersNon-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and DisordersChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Fanconi Anemia;Aplastic AnemiaBiological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Biological: sargramostim;Biological: therapeutic allogeneic lymphocytes;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methylprednisolone;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: peripheral blood stem cell transplantation;Procedure: umbilical cord blood transplantationRoswell Park Cancer InstituteNULLCompleted4 Years75 YearsAll41Phase 2United States
88NCT01163942
(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
89NCT00006379
(ClinicalTrials.gov)
June 20004/10/2000Non-Ablative Allo HSCT For Hematologic Malignancies or SAAPurine-Analog-Containing Non-Myeloablative Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies and Severe Aplastic AnemiaChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Precancerous/Nonmalignant Condition;Small Intestine CancerBiological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Drug: cyclophosphamide;Drug: fludarabine phosphate;Procedure: peripheral blood stem cell transplantationCase Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedN/A70 YearsBoth58Phase 2United States
90NCT00001626
(ClinicalTrials.gov)
June 2, 19973/11/1999Comparing Therapies for the Treatment of Severe Aplastic AnemiaA Randomized Trial of Antithymocyte Globulin and Cyclosporine Versus Cyclophosphamide and Cyclosporine in the Treatment of Severe Aplastic AnemiaSevere Aplastic Anemia (SAA)Drug: antithymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted15 Years110 YearsAll33Phase 2United States
91EUCTR2021-002155-11-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