[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507552":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":41,"locations":50,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":46,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":46,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":46,"overallStatus":53,"whyStopped":46,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SCT800 combined with Daratumumab","EXPERIMENTAL","ITI using low-dose domestic rFVIII (SCT800) (50IU\u002Fkg TIW) and treated with Daratumumab 8mg\u002Fkg 4-8 times. Other immunosuppressants could be added after 3 months.",[13],"Drug: SCT800 and Daratumumab",{"label":15,"type":16,"description":17,"interventionNames":18},"SCT800 alone","ACTIVE_COMPARATOR","ITI using low-dose domestic rFVIII (SCT800) (50IU\u002Fkg TIW) alone. Other immunosuppressants could be added after 3 months.",[19],"Drug: SCT800",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","SCT800 and Daratumumab","SCT800 50IU\u002Fkg TIW alone or treated with Daratumumab 8mg\u002Fkg 4-8 times",[9],[27],"Immune tolerance induction combine anti-CD38",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"SCT800","SCT800 50IU\u002Fkg TIW alone",[15],[33],"Immune tolerance induction only",[35,39],{"name":36,"affiliation":37,"role":38},"Lei Zhang","Chinese Academy of Medical Science and Blood Disease Hospital","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":37,"role":38},"Renchi Yang",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Wei Liu","CONTACT","+8613820261971",null,"liuwei1@ihcams.ac.cn",{"name":36,"role":44,"phone":46,"phoneExt":46,"email":49},"zhanglei1@ihcams.ac.cn",[51],{"facility":52,"status":53,"city":54,"state":46,"zip":46,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","RECRUITING","Tianjin","China","CN",{"type":58,"coordinates":59},"Point",[60,61],117.17667,39.14222,{"lat":61,"lon":60},[64,67,70],{"name":65,"role":44,"phone":46,"phoneExt":46,"email":66},"Shuo Chen","chenshuo@ihcams.ac.cn",{"name":68,"role":44,"phone":46,"phoneExt":46,"email":69},"L Liu","gcp@ihcams.ac.cn",{"name":36,"role":38,"phone":46,"phoneExt":46,"email":46},{"type":72,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[74],{"name":75,"class":76},"Sinocelltech Ltd.","INDUSTRY","100507552","phase-4-iti-using-sct800-alone-or-combining-daratumumab-in-hemophilia-a-adolescents-and-adults-with-high-titer-inhibitor-100507552",false,"NCT05888870","ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor","The Outcome Comparison of Immune Tolerance Induction Therapy Using SCT800 Combined With Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor: a Non-randomized Controlled Trial","Inclusion Criteria\n\n1. Moderate or severe hemophilia A;\n2. Aged 14-66 years old;\n3. Inhibitor positive at 2 consecutive visits;\n4. Inhibitor titer \\> 10 BU at the screening visit.\n\nExclusion Criteria:\n\n1. The patient has contraindications to drug ingredients or hamster protein allergy;\n2. Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s);\n3. Failed systemic ITI treatment in history;\n4. Poor patients compliance;\n5. The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.","ALL","14 Years","65 Years",{"count":88,"type":89},50,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","To evaluate the time of response, sustained remission rate, and relapse rate of CD38 monoclonal antibody (Daratumumab) combined with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.",[95],"Hemophilia A With Inhibitor","2025-02-20",{"date":98,"type":99},"2025-02-24","ACTUAL",{"date":101,"type":99},"2023-11-22",{"date":103,"type":89},"2026-12-01",{"name":5,"class":6},1]