[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543983":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":58,"collaborators":30,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":30,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":30,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Anhui Provincial Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"antibody desensitisation group","EXPERIMENTAL","Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG",[13],"Combination Product: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":19},"COMBINATION_PRODUCT","For allogeneic haematopoietic stem cell transplantation patients with high titers of anti-HLA antibodies present in the body, a desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG is used prior to transplantation.",[9],[20],"Intravenous Immunoglobin",[22],{"name":23,"affiliation":24,"role":25},"Xiaoyu Zhu, ph.D.","The First Affiliated Hospital of USTC (Anhui Provincial Hospital)","PRINCIPAL_INVESTIGATOR",[27,32],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","15255456091",null,"xiaoyuz@ustc.edu.cn",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Yue Wu, M.D.","13805601119","287109658@qq.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)","RECRUITING","Hefei","Anhui","230036","China","CN",{"type":46,"coordinates":47},"Point",[48,49],117.28083,31.86389,{"lat":49,"lon":48},[52,55],{"name":53,"role":28,"phone":29,"phoneExt":30,"email":54},"Xiaoyu Zhu, ph.D","xiaoyuz@ustc.cn",{"name":56,"role":28,"phone":34,"phoneExt":30,"email":57},"Yue Wu, M.D","wuyue20160701@163.com",{"type":59,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100543983","phase-2-the-efficacy-and-safety-of-desensitation-regimen-for-patients-with-high-titers-of-anti-hla-antibodies-prior-to-allo-hsct-100543983",false,"NCT06362967","The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT","The Efficacy and Safety of Immunosorbent or Plasma Exchange Combined With Rituximab and High-dose IVIG for Patients With High Titers of Anti-HLA Antibodies Prior to Allogeneic Hematopoietic Stem Cell Transplantation: A Single-Centre, Single-Arm, Phase II Clinical Study","Inclusion Criteria:\n\n1. Subjects to undergo allo-HSCT\n2. Age 14-60, No gender, No ethnicity\n3. ECOG score ≤ 2\n4. Population reactive antibody screening within 1 month prior to transplantation HLA-class I or class II antibody MFI ≥ 5000\n5. No severe organ failure and no active infections\n6. Subjects and their families voluntarily undergo anti-HLA antibody testing and antibody desensitisation treatment and sign an informed consent form\n\nExclusion Criteria:\n\n1. Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas\n2. Pregnancy\n3. Subjects and\u002For authorised family members who refuse to accept antibody desensitisation treatment\n4. Persons with any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise the safety of the subject and place the results of the study at unnecessary risk\n5. Persons with drug dependence,uncontrolled psychiatric disorders and persons with cognitive dysfunction\n6. Participants in other clinical studies within 3 months\n7. Those whom the investigator considers unsuitable for enrolment (e.g., subjects will not be able to adhere to examinations and treatments due to financial or other issues)","ALL","14 Years","60 Years",{"count":71,"type":72},30,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation",[78],"High Titers of Anti-HLA Antibody (MFI ≥5000)",[80],"immunoadsorption or plasma exchange；rituximab；high-dose IVIG","2024-12-16",{"date":83,"type":84},"2024-12-18","ACTUAL",{"date":86,"type":84},"2024-05-01",{"date":88,"type":72},"2027-06-30",{"name":5,"class":6},1]