[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635129":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":26,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":26,"enrollmentInfo":49,"targetDuration":26,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":26,"overallStatus":58,"whyStopped":26,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":26},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"CsA+Enarodustat","EXPERIMENTAL","CsA 3-5mg\u002Fkg\u002Fd Enarodustat 8mg qd",[13,14],"Drug: Enarodustat","Drug: Cyclosporine (CsA)",{"label":16,"type":17,"description":18,"interventionNames":19},"CsA","ACTIVE_COMPARATOR","CsA 3-5mg\u002Fkg\u002Fd",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Enarodustat","Enarodustat 8mg qd",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Cyclosporine (CsA)","CsA 3-5mg\u002Fkg\u002Fd, trough concentration 100-200ng\u002Fml",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Bing Han","CONTACT","+86 13601059938","hanbing_li@sina.com.cn",{"type":38,"investigatorFullName":33,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Professor","100635129","phase-3-enarodustat--csa-vs-csa-in-newly-diagnosed-td-nsaa-100635129",false,"NCT07548671","Enarodustat + CsA vs CsA in Newly Diagnosed TD-NSAA","Efficacy and Safety of Enarodustat Combined With Cyclosporine Versus Cyclosporine Monotherapy in the Treatment of Newly Diagnosed TD-NSAA","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Diagnosed with aplastic anemia (AA) through routine blood tests, bone marrow puncture, bone marrow biopsy, and exclusion tests, and determined as transfusion-dependent non-severe aplastic anemia (TD NSAA) according to the Camitta criteria; Hemoglobin\\\u003C90g\u002FL;\n3. Had no HLA-matched donors or was not suitable for first-line allogeneic hematopoietic stem cell transplantation (HSCT);\n4. With baseline liver and kidney functions \\\u003C2 ULN;\n5. ECOG score ≤ 2;\n6. Signed the informed consent;\n\nExclusion Criteria:\n\n1. Had other primary or secondary bone marrow failure (BMF) diseases, such as Fanconi anemia, congenital keratinization disorder, etc.;\n2. With evidence of clonal hematological bone marrow diseases (MDS, AML) in cytogenetics;\n3. PNH clone ≥ 50%;\n4. Received HSCT before enrollment;\n5. Previously used immunosuppressive treatments such as ATG, CsA, TPO receptor agonists (TPO-RAs), roxadustat;\n6. Allergic or intolerant to enarodustat or CsA;\n7. Pregnant or lactating patients;\n8. Severe bleeding or infection that cannot be controlled by standard treatment;\n9. Complicated with malignant tumors;\n10. Participated in other clinical trials within 3 months;\n11. Patients considered not suitable to participate in this study by the investigator.","ALL","18 Years",{"count":50,"type":51},90,"ESTIMATED","INTERVENTIONAL",[54],"PHASE3","This study aimed to compare the efficacy and safety of enarodustat combined with cyclosporine versus cyclosporine monotherapy in the treatment of newly-diagnosed tansfusion-dependent non-severe aplastic anemia (TD-NSAA).",[57],"Transfusion-dependent Non-severe Aplastic Anemia","NOT_YET_RECRUITING","2026-04-16",{"date":61,"type":62},"2026-04-23","ACTUAL",{"date":64,"type":51},"2026-04",{"date":66,"type":51},"2029-12",{"name":5,"class":6}]