[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626574":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":19,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":19,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Sinocelltech Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SCT800 prophylaxis and control of bleeding events","EXPERIMENTAL","For prophylaxis, 15-50 IU\u002Fkg SCT800 is intravenously. For control of bleeding events(BE), 10-20 IU\u002Fkg for mild BE, 15 -30IU\u002Fkg for moderate BE, 30-50IU\u002Fkg for severe BE.",[13],"Drug: SCT800 prophylaxis and treatment for bleeding events",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","SCT800 prophylaxis and treatment for bleeding events",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Runhui Wu","CONTACT","+86-13370115037","wurunhuigcp@163.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Beijing children's hospital","RECRUITING","Beijing","Beijing Municipality","000000","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.39723,39.9075,{"lat":39,"lon":38},[42],{"name":22,"role":23,"phone":43,"phoneExt":19,"email":25},"86-13512078851",{"type":45,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100626574","phase-3-efficacy-and-safety-evaluation-study-of-sct800-in-previously-untreated-hemophilia-a-patients-100626574",false,"NCT07437404","Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.","An Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.","Inclusion Criteria:\n\n* Male subjects with severe hemophilia A (FVIII:C \\\u003C 1% in central laboratory tests)\n* previously untreated with pdFVIII\u002FrFVIII, including marketed SCT800 (those who have previously used ≤5EDs of blood products such as cryoprecipitate or fresh frozen plasma are acceptable).\n* FVIII inhibitor negative\n* informed consent.\n\nExclusion Criteria:\n\n* Known allergy to recombinant coagulation factor VIII concentrate or any excipient; known allergy to bovine, rodent or hamster bovine;\n* subjects with a history or family history of FVIII inhibitor formation;\n* Clinical liver function test (ALT、AST) ≥ 5 ULN or clinical kidney function test (BUN，Cr) ≥2 ULN;\n* Patients with other coagulation dysfunction diseases in addition to hemophilia A.\n* International Normalized Ratio (INR) \\> 1.5.","MALE","6 Years",{"count":56,"type":57},36,"ESTIMATED","INTERVENTIONAL",[60],"PHASE3","This is an Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.",[63],"Haemophilia A",[65,66,67],"SCT800","haemophilia A","previously untreated patients","2026-02-23",{"date":70,"type":71},"2026-02-27","ACTUAL",{"date":73,"type":71},"2024-04-26",{"date":75,"type":57},"2028-12-26",{"name":5,"class":6},1]