[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510329":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":45,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":23,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sirolimus on refractory\u002Frelapsed wAIHA","EXPERIMENTAL","A prospective research of the sirolimus efficiency on refractory\u002Frelapsed primary wAIHA patients. Sirolimus dosage: 1-3 mg\u002Fd with plasma concentration 4-15ng\u002FmL. Medication time should last at least 6 months. After reaching the optimal response, responders continue to use sirolimus for 1 year, and then gradually reduce the dosage.",[13],"Drug: Sirolimus",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sirolimus","Oral administration, 1-3 mg\u002Fd, sirolimus plasma concentration: 4-15 ng\u002FmL",[9],null,[22],{"facility":5,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":30,"coordinates":31},"Point",[32,33],116.39723,39.9075,{"lat":33,"lon":32},[36,41],{"name":37,"role":38,"phone":39,"phoneExt":20,"email":40},"Miao Chen","CONTACT","+86 13520112578","chenm@pumch.cn",{"name":42,"role":38,"phone":43,"phoneExt":20,"email":44},"Bing Han","+86 69155028","hanbingpumch@163.com",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Chen Miao","associate professor","100510329","sirolimus-in-the-treatment-of-refractoryrelapsed-waiha-100510329",false,"NCT05925023","Sirolimus in the Treatment of Refractory\u002FRelapsed wAIHA","Sirolimus in the Treatment of Refractory\u002FRelapsed Warm Autoimmune Hemolytic Anemia (AIHA)： a Phase 2 Prospective Trial","Inclusion Criteria:\n\n1. Age ≥18 years old.\n2. Diagnosed as primary warm autoimmune hemolytic anemia or Evans syndrome (primary or secondary). There is no treatment indication of other systemic involvement in the original disease if secondary.\n3. No response to glucocorticoid therapy or recurrence.\n4. Baseline liver (ALT, AST) was less than 2 times the normal value.\n5. No active infection; Not pregnant or breastfeeding.\n6. Agree to sign the consent form.\n\nExclusion Criteria:\n\n1. Patients with connective tissue disease or other organs involvement\n2. Infection or bleeding that cannot be controlled by standard treatment.\n3. Active HIV, HCV or HBV infection or cirrhosis or portal hypertension.\n4. Progressed uncontrolled malignant tumors and lymphoma\n5. Cirrhosis or portal hypertension.\n6. Pregnant or breastfeeding.","ALL","18 Years","90 Years",{"count":60,"type":61},22,"ESTIMATED","INTERVENTIONAL",[64],"NA","Autoimmune hemolytic anemia (AIHA) is a rare and heterogeneous disorder characterized by the destruction of red blood cells through warm or cold antibodies. Glucocorticoid (combined with rituximab) is the first-line treatment. However, the recurrence rate is very high and some patients may not respond to steroids. Second-line therapies include cyclosporine A (CsA), cyclophosphamide, rituximab, azathioprine, and even splenectomy. Our previous study of sirolimus in refractory\u002Frelapsed AIHA and ES found an effective rate of 80%. Therefore, the investigators plan to explore the efficacy and safety of sirolimus in the treatment of refractory\u002Frelapsed wAIHA.",[67],"Warm Autoimmune Hemolytic Anemia",[69,70,71,72,73],"warm autoimmune hemolytic anemia","Evans syndrome","refractory\u002Frelapsed","sirolimus","efficacy","2025-08-06",{"date":76,"type":77},"2025-08-08","ACTUAL",{"date":79,"type":77},"2023-06-24",{"date":81,"type":61},"2025-12",{"name":5,"class":6},1]