[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569553":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":48,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":9,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"hypo-CASH","EXPERIMENTAL","ALG\u002FCsA and herombopag and reduced dose of cyclophosphamide",[13],"Drug: Reduced dose of cyclophosphamide combined with standard immunosuppressive therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Reduced dose of cyclophosphamide combined with standard immunosuppressive therapy","Severe aplastic anemia patients will receive a daily dose of Anti-lymphocyte globulin (25mg\u002Fkg) for the initial five days at the beginning of the treatment. Cyclosporine will be administered daily at a dosage of 3-5mg\u002Fkg. Herombopag will be administered daily at a dosage of 15mg starting from the first day of treatment and continuing for a duration of six months. Cyclophosphamide (20mg\u002Fkg) will be administered on days 15-16.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Hong Pan, MD","CONTACT","‭15822458611‬","panhong@ihcams.ac.cn",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Jingyu Zhao, MPH","13752253515","zhaojingyu@ihcams.ac.cn",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Red Blood Cell Disorders Center and Regenerative Medicine Center","RECRUITING","Tianjin","Tianjin Municipality","301617","China","CN",{"type":41,"coordinates":42},"Point",[43,44],117.17667,39.14222,{"lat":44,"lon":43},[47],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Jun Shi","Director of the Red Blood Cell Disorders Center & Director of the Regenerative Medicine Clinic","100569553","phase-2-reduced-dose-of-cyclophosphamide-combined-with-standard-immunosuppressive-therapy-to-treat-severe-aplastic-anemia-100569553",false,"NCT06695741","Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia","Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy as Front-line Therapy in Patients With Severe Aplastic Anemia","Inclusion Criteria:\n\n* Subject has a diagnosis of naïve severe or very severe aplastic anemia\n* Male or female age ≥ 12 years\n* Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation.\n* ECOG performance status ≤2\n* Willing and able to comply with the requirements for this study and written informed consent.\n\nExclusion Criteria:\n\n* Previously received immunosuppressive therapy \\> 4 weeks\n* Previously treated with TPO-RA \\> 4 weeks\n* Have an allergy or intolerance to anti-lymphocyte globulin, cyclosporine, herombopag or cyclophosphamide.\n* Uncontrolled fungal, bacterial, or viral infection. Hepatitis-associated aplastic anemia is allowed; hepatitis B or C infection is permitted unless it causes severe liver failure.\n* Tested positive for HIV or syphilis\n* Presence of severe liver, kidney, or heart failure, or other life-threatening comorbidities.\n* History of radiotherapy and chemotherapy for malignant solid tumors in recent 5 years\n* Combined with other serious disorders\n* Pregnant or breast-feeding patients\n* Patients considered to be ineligible for the study by the investigator for reasons other than the above.","ALL","12 Years",{"count":62,"type":63},75,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","This is a prospective, single-center, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of anti-lymphocyte globulin plus herombopag in combination with the reduced dose of cyclophosphamide (hypo-CASH) for severe aplastic anemia.",[69,70,71],"Severe Aplastic Anemia","Cyclophosphamide Reduced-dose","Immunosuppressive Therapy","2024-11-16",{"date":74,"type":75},"2024-11-19","ACTUAL",{"date":77,"type":75},"2024-11-01",{"date":79,"type":63},"2027-06-30",{"name":5,"class":6},1]