[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627802":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":45,"locations":55,"responsibleParty":75,"collaborators":49,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":49,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":49,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":57,"whyStopped":49,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"wAIHA-A","EXPERIMENTAL","Orelabrutinib 50 mg, orally, once daily.After 4 weeks of treatment, if still transfusion-dependent or hemoglobin increase is \\\u003C 20 g\u002FL, the dose may be increased to 100 mg qd. Treatment can be discontinued if ineffective at 12 weeks.\n\nStable doses of glucocorticoids (e.g., prednisone ≤ 15 mg\u002Fday) are permitted, and their tapering process should be recorded.",[13],"Drug: Orelabrutinib-50",{"label":15,"type":10,"description":16,"interventionNames":17},"wAIHA-B","Orelabrutinib 100 mg, orally, once daily. The treatment course is at least 12 weeks. Treatment can be discontinued if ineffective at 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety.\n\nStable doses of glucocorticoids (e.g., prednisone ≤ 15 mg\u002Fday) are permitted, and their tapering process should be recorded.",[18],"Drug: Orelabrutinib-100",{"label":20,"type":10,"description":21,"interventionNames":22},"cAIHA-C","Orelabrutinib 150 mg, orally, once daily. The treatment course is at least 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety.",[23],"Drug: Orelabrutinib-150",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Orelabrutinib-50","Orelabrutinib 50 mg, orally, once daily. After 4 weeks of treatment, if still transfusion-dependent or hemoglobin increase is \\\u003C 20 g\u002FL, the dose may be increased to 100 mg qd. Treatment can be discontinued if ineffective at 12 weeks.\n\nStable doses of glucocorticoids (e.g., prednisone ≤ 15 mg\u002Fday) are permitted, and their tapering process should be recorded.",[9],[9],{"type":26,"name":32,"description":16,"armGroupLabels":33,"otherNames":34},"Orelabrutinib-100",[15],[15],{"type":26,"name":36,"description":21,"armGroupLabels":37,"otherNames":38},"Orelabrutinib-150",[20],[39],"wAIHA-C",[41],{"name":42,"affiliation":43,"role":44},"Miao Chen","Peking Union Medical College","PRINCIPAL_INVESTIGATOR",[46,51],{"name":42,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","+86 18618230229",null,"chenm@pumch.cn",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Chuanhuan Liu","86+1323861016","LiuCH0310@163.com",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.39723,39.9075,{"lat":67,"lon":66},[70,71,73,74],{"name":42,"role":47,"phone":48,"phoneExt":49,"email":50},{"name":52,"role":47,"phone":72,"phoneExt":49,"email":54},"+86 1323861016",{"name":42,"role":44,"phone":49,"phoneExt":49,"email":49},{"name":52,"role":44,"phone":49,"phoneExt":49,"email":49},{"type":44,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Chen Miao","Director","100627802","phase-2-orelabrutinib-in-the-treatment-of-relapsedrefractory-aiha-100627802",false,"NCT07453368","Orelabrutinib in the Treatment of Relapsed\u002FRefractory AIHA","Orelabrutinib in the Treatment of Relapsed\u002FRefractory Autoimmune Hemolytic Anemia: A Prospective, Dose-Escalation Cohort Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients with a definitive diagnosis of AIHA. wAIHA or Evans syndrome, primary or secondary to connective tissue disease (CTD) or lymphoproliferative disorder (LPD). If secondary, CTD should have no indication for treatment for other system involvement, and LPD should be in an asymptomatic, observation phase without treatment indication.\n\ncAIHA, primary or secondary to LPD. If secondary, LPD should be in an asymptomatic, observation phase without treatment indication.\n\n* For wAIHA: No response (no partial response after 3 weeks) to full-dose glucocorticoid therapy (1-2 mg\u002Fkg\u002Fday), intolerance, or relapse (after initial response, hemoglobin drop ≥20 g\u002FL or requiring re-initiation of immunosuppressive therapy). And hemoglobin ≤ 100 g\u002FL.\n* For cAIHA: No response or relapse after anti-CD20 monoclonal antibody therapy (after initial response, hemoglobin drop ≥20 g\u002FL or recurrence of vascular symptoms, or requiring re-initiation of immunosuppressive therapy), or unsuitable for anti-CD20 therapy. And hemoglobin ≤ 100 g\u002FL or presence of vascular symptoms.\n* Baseline liver and kidney function (ALT, Cr) within 2 times the upper limit of normal (elevated AST, LDH, Bil due to hemolysis are not used as indicators for liver function assessment).\n* Agreement to sign the informed consent form.\n\nExclusion Criteria:\n\n* Active involvement of other major organs due to connective tissue disease.\n* Uncontrolled infection or bleeding per standard treatment.\n* Uncontrolled active HIV, HCV, or HBV infection per standard treatment.\n* Concurrent advanced uncontrolled malignancy, lymphoma.\n* Presence of other uncorrected types of anemia at screening, such as nutritional anemia, thalassemia, etc.\n* Currently receiving glucocorticoid therapy at screening and unable to discontinue or taper to ≤ 15 mg\u002Fday (prednisone equivalent) within 1 week before enrollment.\n* Currently receiving treatment with medications such as cyclosporine, tacrolimus, sirolimus, cyclophosphamide, azathioprine, stanozolol, testosterone undecanoate, danazol, etc., at screening, and the treatment duration at a stable dose is \\\u003C 12 weeks, or unable to discontinue directly.\n* Last dose of rituximab \\\u003C 3 months prior to enrollment.\n* Prior treatment with any BTK inhibitor.\n* Liver cirrhosis or portal hypertension.\n* Pregnant or breastfeeding women.\n* Participation in another clinical trial within the past 3 months.","ALL","18 Years","85 Years",{"count":89,"type":90},50,"ESTIMATED","INTERVENTIONAL",[93],"PHASE2","1. wAIHA Treatment Regimen: Group A (50mg group): Orelabrutinib 50 mg, orally, once daily. After 4 weeks of treatment, if still transfusion-dependent or hemoglobin increase is \\\u003C 20 g\u002FL, the dose may be increased to 100 mg qd. Treatment can be discontinued if ineffective at 12 weeks.\n\n   Group B (100mg group): Orelabrutinib 100 mg, orally, once daily. The treatment course is at least 12 weeks. Treatment can be discontinued if ineffective at 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety.\n2. cAIHA Treatment Regimen: Group C (150mg group): Orelabrutinib 150 mg, orally, once daily. The treatment course is at least 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety.",[96],"Autoimmune Hemolytic Anemia (AIHA)",[98,99,100,101],"Autoimmune Hemolytic Anemia","Orelabrutinib","Treatment","Cohort Study","2026-06-15",{"date":104,"type":105},"2026-06-16","ACTUAL",{"date":107,"type":105},"2026-03-01",{"date":109,"type":90},"2028-03-01",{"name":5,"class":6},1]