[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586950":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":302,"collaborators":11,"id":304,"slug":305,"hasResults":306,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":11,"eligibilityCriteria":310,"healthyVolunteers":306,"sex":311,"minAge":312,"maxAge":313,"enrollmentInfo":314,"targetDuration":11,"studyType":317,"phases":318,"briefSummary":320,"conditions":321,"keywords":11,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},{"fullName":5,"class":6},"Jiangsu BioJeTay Biotechnology Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous administration of STSP-0601","EXPERIMENTAL",null,[13],"Drug: STSP-0601 for Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","STSP-0601 for Injection","Evaluation of the Efficacy of Single-Dose and Continuous Administration of STSP-0601 Injection for the Treatment of Bleeding in Patients with Hemophilia A or B with Inhibitors",[9],[21],{"name":22,"affiliation":23,"role":24},"Lei Zhang, Ph.D","Hospital of Hematology, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Yanli Wang","CONTACT","010-67519614","wangyanli@staidson.com",[32,51,67,82,96,111,126,140,155,170,185,200,215,230,244,259,272,287],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Anhui Provincial Hospital","NOT_YET_RECRUITING","Hefei","Anhui","230001","China","CN",{"type":41,"coordinates":42},"Point",[43,44],117.28083,31.86389,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":11,"email":50},"Changcheng Zheng","13956961162","zhengchch1123@163.com",{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":38,"countryCode":39,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Lanzhou University First Hospital","RECRUITING","Lanzhou","Gansu","730000",{"type":41,"coordinates":58},[59,60],103.83987,36.05701,{"lat":60,"lon":59},[63],{"name":64,"role":28,"phone":65,"phoneExt":11,"email":66},"Yaming Xi","13919110815","ncuyfygcp2018@163.com",{"facility":68,"status":53,"city":69,"state":70,"zip":71,"country":38,"countryCode":39,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Nanfang Hospital, Southern Medical University","Guangzhou","Guangdong","510515",{"type":41,"coordinates":73},[74,75],113.25,23.11667,{"lat":75,"lon":74},[78],{"name":79,"role":28,"phone":80,"phoneExt":11,"email":81},"Jing Sun","13316202696","jsun-cn@qq.com",{"facility":83,"status":53,"city":84,"state":70,"zip":85,"country":38,"countryCode":39,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Shenzhen Second People's Hospital","Shenzhen","518000",{"type":41,"coordinates":87},[88,89],114.0683,22.54554,{"lat":89,"lon":88},[92],{"name":93,"role":28,"phone":94,"phoneExt":11,"email":95},"Xin Du","13602523722","duxingz@medmail.com.cn",{"facility":97,"status":53,"city":98,"state":99,"zip":100,"country":38,"countryCode":39,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"The First affiliated hospital of Guangxi Medical University","Nanning","Guangxi","530021",{"type":41,"coordinates":102},[103,104],108.31667,22.81667,{"lat":104,"lon":103},[107],{"name":108,"role":28,"phone":109,"phoneExt":11,"email":110},"Peng Cheng","13977166448","13977166448@qq.com",{"facility":112,"status":53,"city":113,"state":114,"zip":115,"country":38,"countryCode":39,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"North China University of Science and Technology Affiliated Hospital","Tangshan","Hebei","063000",{"type":41,"coordinates":117},[118,119],118.18319,39.64381,{"lat":119,"lon":118},[122],{"name":123,"role":28,"phone":124,"phoneExt":11,"email":125},"Zhenyu Yan","15383055876","hbyzy2011@163.com",{"facility":127,"status":53,"city":128,"state":129,"zip":130,"country":38,"countryCode":39,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Harbin First Hospital Hematology Tumor Research Center","Harbin","Heilongjiang","150000",{"type":41,"coordinates":132},[133,134],126.65,45.75,{"lat":134,"lon":133},[137],{"name":138,"role":28,"phone":139,"phoneExt":11,"email":11},"Jun Ma","0451-84883471",{"facility":141,"status":53,"city":142,"state":143,"zip":144,"country":38,"countryCode":39,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Henan Cancer Hospital","Zhengzhou","Henan","300020",{"type":41,"coordinates":146},[147,148],113.64861,34.75778,{"lat":148,"lon":147},[151],{"name":152,"role":28,"phone":153,"phoneExt":11,"email":154},"Hu Zhou","13939068863","papertigerhu@163.com",{"facility":156,"status":34,"city":157,"state":158,"zip":159,"country":38,"countryCode":39,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Huazhong University of Science and Technology Union Hospital","Wuhan","Hubei","430022",{"type":41,"coordinates":161},[162,163],114.26667,30.58333,{"lat":163,"lon":162},[166],{"name":167,"role":28,"phone":168,"phoneExt":11,"email":169},"Huafang Wang","18627896116","Huafang_wang@163.com",{"facility":171,"status":53,"city":172,"state":173,"zip":174,"country":38,"countryCode":39,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Jiangsu Provincial Hospital","Nanjing","Jiangsu","210029",{"type":41,"coordinates":176},[177,178],118.77778,32.06167,{"lat":178,"lon":177},[181],{"name":182,"role":28,"phone":183,"phoneExt":11,"email":184},"Ruinan Lu Lu","13813952651","Luruinan@jsph.org.cn",{"facility":186,"status":53,"city":187,"state":188,"zip":189,"country":38,"countryCode":39,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi","330000",{"type":41,"coordinates":191},[192,193],115.85306,28.68396,{"lat":193,"lon":192},[196],{"name":197,"role":28,"phone":198,"phoneExt":11,"email":199},"Ruibin Huang","13970006820","rbhuang69@163.com",{"facility":201,"status":53,"city":202,"state":203,"zip":204,"country":38,"countryCode":39,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Jinan Central Clinical College of Shandong First Medical University","Jinan","Shandong","250013",{"type":41,"coordinates":206},[207,208],116.99722,36.66833,{"lat":208,"lon":207},[211],{"name":212,"role":28,"phone":213,"phoneExt":11,"email":214},"Yun Chen","13370582720","chyun@163.com",{"facility":216,"status":34,"city":217,"state":218,"zip":219,"country":38,"countryCode":39,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Second hospital of Shanxi Medical University","Taiyuan","Shanxi","030001",{"type":41,"coordinates":221},[222,223],112.56028,37.86944,{"lat":223,"lon":222},[226],{"name":227,"role":28,"phone":228,"phoneExt":11,"email":229},"Linhua Yang","13099077195","yanglh5282@163.com",{"facility":231,"status":53,"city":232,"state":218,"zip":233,"country":38,"countryCode":39,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Xi'an Central Hospital","Xi’an","710000",{"type":41,"coordinates":235},[236,237],113.52486,35.99785,{"lat":237,"lon":236},[240],{"name":241,"role":28,"phone":242,"phoneExt":11,"email":243},"Yanping Song","13572973308","xjtusyp@163.com",{"facility":245,"status":34,"city":246,"state":247,"zip":248,"country":38,"countryCode":39,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital","Chengdu","Sichuan","610072",{"type":41,"coordinates":250},[251,252],104.06667,30.66667,{"lat":252,"lon":251},[255],{"name":256,"role":28,"phone":257,"phoneExt":11,"email":258},"Xiaobing Huang","18981838236","hxb_trial@163.com",{"facility":23,"status":53,"city":260,"state":261,"zip":144,"country":38,"countryCode":39,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Tianjin","Tianjin Municipality",{"type":41,"coordinates":263},[264,265],117.17667,39.14222,{"lat":265,"lon":264},[268],{"name":269,"role":28,"phone":270,"phoneExt":11,"email":271},"Lei Zhang","022-23909095","zhanglei1@ihcams.ac.cn",{"facility":273,"status":53,"city":274,"state":275,"zip":276,"country":38,"countryCode":39,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"The Second Affiliated Hospital of Kunming Medical University","Kunming","Yunnan","650000",{"type":41,"coordinates":278},[279,280],102.71833,25.03889,{"lat":280,"lon":279},[283],{"name":284,"role":28,"phone":285,"phoneExt":11,"email":286},"Zeping Zhou","18788571605","zhouzeping@kmmu.edu.cn",{"facility":288,"status":53,"city":289,"state":290,"zip":291,"country":38,"countryCode":39,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"Wenzhou People's Hospital","Wenzhou","Zhejiang","325000",{"type":41,"coordinates":293},[294,295],120.66682,27.99942,{"lat":295,"lon":294},[298],{"name":299,"role":28,"phone":300,"phoneExt":11,"email":301},"Miaoyong Zhu","13353352636","13353352636@189.cn",{"type":303,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100586950","phase-3-phase-iii-clinical-trial-of-stsp-0601-for-injection-in-hemophilia-patients-100586950",false,"NCT06922045","Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients","A Phase III Clinical Study on the Efficacy and Safety of STSP-0601 for Injection in Patients With Hemophilia Associated With Inhibitors, With a Multicenter, Open Evaluation Approach","Inclusion Criteria:\n\n1. 12 ≤age≤70 years of age.\n2. Hemophilia A or B patients.\n3. Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.\n4. Establish proper venous access.\n5. There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.\n6. Agree to use adequate contraception to avoid pregnancy.\n7. Provide signed informed consent.\n\nExclusion Criteria:\n\n1. Have any coagulation disorder other than hemophilia.\n2. Plan to receive prophylactic treatment of coagulation factor during the trail.\n3. Patients plan to receive Emicizumab during the trial.\n4. Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial.\n5. Have a history of arterial and\u002For venous thrombotic events.\n6. Platelet \\\u003C100×109\u002FL.\n7. Hemoglobin\\\u003C90g\u002FL.\n8. Severe liver or kidney disease.\n9. Severe bleeding event occurred within 4 weeks before the first administration.\n10. Accepted major operation or blood transfusion within 4 weeks before the first administration.\n11. Have a known allergy to STSP-0601.\n12. Pregnant, lactating, or blood pregnancy test positive female subjects\n13. Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).\n14. Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received.\n15. Patients not suitable for the trail according to the judgment of the investigators.","ALL","12 Years","70 Years",{"count":315,"type":316},40,"ESTIMATED","INTERVENTIONAL",[319],"PHASE3","This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor",[322],"Hemophilia","2026-04-22",{"date":325,"type":326},"2026-04-23","ACTUAL",{"date":328,"type":326},"2025-03-26",{"date":330,"type":316},"2027-03",{"name":5,"class":6},18]