[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514857":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention（Anti-CD38 antibody）","EXPERIMENTAL","10 enrolled subjects: once a week x 8 doses",[13],"Drug: Anti-CD38 antibody Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Anti-CD38 antibody Injection","intravenous Anti-CD38 antibody administration\n\nThis study adopts a prospective, single arm, open design method. Ten subjects were enrolled in the study and were treated with Anti-CD38 antibody (16mg\u002Fkg\u002Fw) for 8 weeks.\n\nThe first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg\u002Fkg Anti-CD38 antibody once a week for 8 weeks to observe the safety and efficacy during treatment.\n\nThe second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Anti-CD38 antibody after treatment.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Lei Zhang, MD","Chinese Academy of Medical Science and Blood Disease Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Yunfei Chen, MD","CONTACT","+8618502220788","chenyunfei@ihcams.ac.cn",[33],{"facility":24,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":41,"coordinates":42},"Point",[43,44],117.17667,39.14222,{"lat":44,"lon":43},[47],{"name":28,"role":29,"phone":48,"phoneExt":20,"email":31},"+86-22-23909009",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100514857","phase-2-anti-cd38-antibody-treating-aps-with-thrombocytopenia-100514857",false,"NCT05983952","Anti-CD38 Antibody Treating APS With Thrombocytopenia","A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia","Inclusion Criteria:\n\n* Age 18 and above, male or female.\n* Conform to the diagnostic criteria of antiphospholipid syndrome (APS).\n* Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab, CSA or CTX etc., or those who cannot chose other second-line therapy.\n* Platelet count of \\\u003C30 X 10\\^9\u002FL.\n* With normal hepatic and renal functions.\n* ECOG physical state score ≤ 2 points.\n* Cardiac function of the New York Society of Cardiac Function ≤ 2.\n* Signed and dated written informed consent\n\nExclusion Criteria:\n\n* Received any treatment of anti-CD38 antibody drug\n* Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases;\n* HIV positive;\n* Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;\n* At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis;\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past;\n* Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;\n* Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;\n* Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);\n* Patients with septicemia or other irregular severe bleeding;\n* Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.","ALL","18 Years",{"count":61,"type":62},10,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","To evaluate the safety and efficacy of anti-CD38 antibody in the treatment of antiphospholipid syndrome with secondary thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including rituximab and\u002For TPO-RA.",[68,69],"Antiphospholipid Syndrome","Thrombocytopenia","2025-07-31",{"date":72,"type":73},"2025-08-05","ACTUAL",{"date":75,"type":73},"2023-08-01",{"date":77,"type":62},"2025-08",{"name":5,"class":6},1]