[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646904":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":33,"responsibleParty":246,"collaborators":20,"id":248,"slug":249,"hasResults":250,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":20,"eligibilityCriteria":254,"healthyVolunteers":250,"sex":255,"minAge":256,"maxAge":257,"enrollmentInfo":258,"targetDuration":20,"studyType":261,"phases":262,"briefSummary":264,"conditions":265,"keywords":20,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"fullName":5,"class":6},"Hangzhou Gensciences Biopharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"prophylactic treatment","EXPERIMENTAL","Subjects in PK Subgroup receive a single and multiple dose of 50 IU\u002Fkg FRSW107 at Visit 1 and Visit 5, respectively. PK samples will be collected up to 72 hours after the start of administration.After completion of PK blood sampling for the first dose and prior to availability of the corresponding PK data, subjects may continue prophylactic treatment with FRSW107 at a dose of 50 IU\u002Fkg every 3 days until their PK data are obtained.Once the first-dose PK data of a subject are available, individualized prophylactic treatment with FRSW107 will be implemented based on the PK results. On the premise of maintaining a trough FVIII activity level of ≥1%, the investigator will determine the appropriate individualized prophylactic regimen for the subject. The recommended prophylactic dosing interval is Q3D, with an optional dose range of 25-50 IU\u002Fkg.\n\nFor subjects in the non-PK subgroup, the investigator will select the initial prophylactic dose within the recommended range of 25-50 IU\u002Fkg.",[13],"Drug: FRSW107",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","FRSW107","For subjects in the PK subgroup: they will receive a dose of 50 IU\u002Fkg at the first dose visit 1 to obtain preliminary pharmacokinetic (PK) data. After assessment by the investigator, individualized prophylactic treatment (25\\~50 IU\u002Fkg, Q3D) will be administered to maintain the trough concentration of FVIII activity at ≥1%.\n\nFor subjects not in the PK subgroup: they will receive prophylactic treatment at a dose of 25\\~50 IU\u002Fkg once every three days.\n\nIf a subject experiences a breakthrough bleeding episode requiring treatment, the investigator shall determine the appropriate dosage (recommended dose range: 20\\~50 IU\u002Fkg) and administration frequency.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Renchi Yang, PhD","Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.","STUDY_CHAIR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Lijia Liu","CONTACT","+ 86 18645377793","lijialiu@gensciences.cn",{"name":23,"role":29,"phone":20,"phoneExt":20,"email":20},[34,50,62,73,84,95,106,117,128,139,150,161,172,183,194,205,216,227,238],{"facility":35,"status":36,"city":37,"state":38,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College","RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":42,"coordinates":43},"Point",[44,45],117.17667,39.14222,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":20,"phoneExt":20,"email":20},"Feng Xue",{"facility":51,"status":52,"city":53,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Fuyang Hospital, Affiliated to Anhui Medical University","NOT_YET_RECRUITING","Fuyang",{"type":42,"coordinates":55},[56,57],115.81667,32.9,{"lat":57,"lon":56},[60],{"name":61,"role":29,"phone":20,"phoneExt":20,"email":20},"Qingyi Wang",{"facility":63,"status":52,"city":64,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Fujian Medical University Union Hospital","Fuzhou",{"type":42,"coordinates":66},[67,68],119.30611,26.06139,{"lat":68,"lon":67},[71],{"name":72,"role":29,"phone":20,"phoneExt":20,"email":20},"Meijuan Huang",{"facility":74,"status":52,"city":75,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Nanfang Hospital of Southern Medical University","Guangzhou",{"type":42,"coordinates":77},[78,79],113.25,23.11667,{"lat":79,"lon":78},[82],{"name":83,"role":29,"phone":20,"phoneExt":20,"email":20},"Jing Sun",{"facility":85,"status":52,"city":86,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Anhui Provincial Hospital","Hefei",{"type":42,"coordinates":88},[89,90],117.28083,31.86389,{"lat":90,"lon":89},[93],{"name":94,"role":29,"phone":20,"phoneExt":20,"email":20},"Xiaoyu Zhu",{"facility":96,"status":52,"city":97,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Jinan central hospital","Jinan",{"type":42,"coordinates":99},[100,101],116.99722,36.66833,{"lat":101,"lon":100},[104],{"name":105,"role":29,"phone":20,"phoneExt":20,"email":20},"Yun Chen",{"facility":107,"status":52,"city":108,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"The Second Affiliated Hospital of Kunming Medical University","Kunming",{"type":42,"coordinates":110},[111,112],102.71833,25.03889,{"lat":112,"lon":111},[115],{"name":116,"role":29,"phone":20,"phoneExt":20,"email":20},"Zeping Zhou",{"facility":118,"status":52,"city":119,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"The First Affiliated Hospital of Guangxi Medical University","Nanning",{"type":42,"coordinates":121},[122,123],108.31667,22.81667,{"lat":123,"lon":122},[126],{"name":127,"role":29,"phone":20,"phoneExt":20,"email":20},"Peng Cheng",{"facility":129,"status":52,"city":130,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Affiliated Hospital of Nantong University","Nantong",{"type":42,"coordinates":132},[133,134],120.87472,32.03028,{"lat":134,"lon":133},[137],{"name":138,"role":29,"phone":20,"phoneExt":20,"email":20},"Li Yang",{"facility":140,"status":52,"city":141,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"The First Affiliated Hospital of Nanyang Medical College","Nanyang",{"type":42,"coordinates":143},[144,145],112.54659,33.00524,{"lat":145,"lon":144},[148],{"name":149,"role":29,"phone":20,"phoneExt":20,"email":20},"Huibing Dang",{"facility":151,"status":52,"city":152,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Qinghai Provincial People's Hospital","Qinghai",{"type":42,"coordinates":154},[155,156],106.075,25.80833,{"lat":156,"lon":155},[159],{"name":160,"role":29,"phone":20,"phoneExt":20,"email":20},"Wenqian Li",{"facility":162,"status":52,"city":163,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"The Second Hospital of Shanxi Medical University","Taiyuan",{"type":42,"coordinates":165},[166,167],112.56028,37.86944,{"lat":167,"lon":166},[170],{"name":171,"role":29,"phone":20,"phoneExt":20,"email":20},"Zhuanzhen Zheng",{"facility":173,"status":52,"city":174,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"North China University of Science and Technology Affiliated Hospital","Tangshan",{"type":42,"coordinates":176},[177,178],118.18319,39.64381,{"lat":178,"lon":177},[181],{"name":182,"role":29,"phone":20,"phoneExt":20,"email":20},"Zhenyu Yan",{"facility":184,"status":52,"city":185,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Wenzhou People's Hospital","Wenzhou",{"type":42,"coordinates":187},[188,189],120.66682,27.99942,{"lat":189,"lon":188},[192],{"name":193,"role":29,"phone":20,"phoneExt":20,"email":20},"Miaoyong Zhu",{"facility":195,"status":52,"city":196,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology.","Wuhan",{"type":42,"coordinates":198},[199,200],114.26667,30.58333,{"lat":200,"lon":199},[203],{"name":204,"role":29,"phone":20,"phoneExt":20,"email":20},"Huafang Wang",{"facility":206,"status":52,"city":207,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Affiliated Hospital of Jiangnan University","Wuxi",{"type":42,"coordinates":209},[210,211],120.28857,31.56887,{"lat":211,"lon":210},[214],{"name":215,"role":29,"phone":20,"phoneExt":20,"email":20},"Haiying Hua",{"facility":217,"status":52,"city":218,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Xi'an Central Hospital","Xi'an",{"type":42,"coordinates":220},[221,222],108.92861,34.25833,{"lat":222,"lon":221},[225],{"name":226,"role":29,"phone":20,"phoneExt":20,"email":20},"Yanping Song",{"facility":228,"status":52,"city":229,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Henan Cancer Hospital","Zhengzhou",{"type":42,"coordinates":231},[232,233],113.64861,34.75778,{"lat":233,"lon":232},[236],{"name":237,"role":29,"phone":20,"phoneExt":20,"email":20},"Hu Zhou",{"facility":239,"status":52,"city":229,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":240,"geoPoint":242,"contacts":243},"Zhengzhou People's Hospital",{"type":42,"coordinates":241},[232,233],{"lat":233,"lon":232},[244],{"name":245,"role":29,"phone":20,"phoneExt":20,"email":20},"Shuxia Guo",{"type":247,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100646904","phase-3-study-of-recombinant-human-coagulation-factor-viii-fc-fusion-protein-frsw107-as-prophylactic-treatment-100646904",false,"NCT07684898","Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) as Prophylactic Treatment.","A Single-Arm, Open-Label, Multicenter Phase III Clinical Study Evaluating the Efficacy, Safety, Immunogenicity and Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) as Prophylactic Therapy in Patients With Severe Hemophilia A (Adults and Adolescents)","Inclusion Criteria:\n\n1.12≤ age ≤65 year-old men; 2.Subjects with clinically confirmed severe hemophilia A, i.e. at screening (central laboratory testing) or previous medical records confirm: FⅧ activity \\\u003C 1%; 3.Previous documented treatment with any recombinant and\u002For blood-derived coagulation factor Ⅷ products or cryoprecipitation products and dosed ≥150 exposure days (EDs≥150) ; 4.Normal prothrombin time (PT) or International Normalized Ratio (INR)\\\u003C1.3; 5.Bleeding events were recorded in detail for at least 6 months prior to screening; 6.Fully understand and know about this study and sign informed consent to participate in the clinical study voluntarily, subject and\u002For their guardian can cooperate with them for bleeding treatment at home, and have the ability to complete all study procedures\n\nExclusion Criteria:\n\n1. Known or suspected allergy to the investigational drug or its excipients, including mouse or hamster proteins;\n2. Hypersensitivity or anaphylaxis after FⅧ or IgG2 injection in the past;\n3. FⅧ inhibitor positive (≥0.6 BU\u002FmL) during the screening period, or have a history of FⅧ inhibitor positive in the past, or a family history of FⅧ inhibitor positive;\n4. Von Willebrand factor (vWF) antigen test results were lower than the lower limit of normal value;\n5. Severe anemia at the screening stage (hemoglobin \\\u003C 60 g\u002FL);\n6. Platelet count during screening period \\\u003C 100×109 \u002FL;\n7. Abnormal liver function: Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \\>3 times upper limit of normal (ULN); or Serum total bilirubin (TBIL) \\>1.5x ULN;\n8. Subjects with abnormal renal function: Creatinine clearance (Ccr) \\\u003C50 ml\u002Fmin (according to Cockcroft and Gault formula); or Serum creatinine (Cr) \\>1.5x ULN;\n9. Subjects with active hepatitis C, that is, hepatitis C virus (HCV) antibody positive and HCV RNA positive; Or anti-treponema pallidum specific antibody (TPHA) positive; Or positive for antibodies against the human immunodeficiency virus (HIV);\n10. Subjects with coagulation dysfunction other than hemophilia A;\n11. Have a medical condition that may increase the risk of bleeding;\n12. A history of drug or alcohol abuse;\n13. Have a known mental disorder that may affect trial compliance;\n14. Subjects who have received transfusions of blood or blood components within 4 weeks prior to screening;\n15. Participants who had participated in other Interventional clinical trials within 1 month before screening;\n16. Use of any anticoagulant or antiplatelet drugs, off-label maximum dose of non-steroidal anti-inflammatory drugs (NSAID) within 7 days prior to screening; Or subjects who need to be treated with anticoagulant or antiplatelet drugs or off-label maximum doses of SAID during clinical trials;\n17. Severe cardiovascular and cerebrovascular disease or major thromboembolic events, such as stroke, myocardial infarction, unstable angina, congestive heart failure (New York Heart Association \\[NYHA\\] grade ≥ III), and severe arrhythmias (including QTc interphase \\> 480 ms, corrected by Fridericia formula), uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥100 mmHg), deep vein thrombosis, etc.\n18. Subjects who have received emicizumab within 6 months prior to the first administration of study drug, or have previously received fitusiran (siRNA, brand name: CEPHEIN®) or gene therapy;\n19. Subjects who have received monoclonal antibody therapy, Fc fusion protein products, or intravenous immunoglobulin within 3 months prior to the first administration of study drug;\n20. Subjects who have undergone major surgery within 3 months prior to the first administration of study drug, or those who plan to receive surgery during the study period;\n21. Subjects who have received any standard half-life FⅧ preparations (e.g., Advate, Kovaltry, Octate, Recombinate, NovoEight, Anjiyin, etc.) within 3 days or 5 half-lives (whichever is longer) prior to the first administration of study drug; patients who have received any other extended half-life FⅧ preparations (e.g., Noxyte) within 4 days or 5 half-lives (whichever is longer) prior to the first administration of study drug;\n22. Study patients with fever, severe active bacterial or viral infection, and allergies within 2 weeks before the first administration of the drug;\n23. Systemic immunomodulators (such as glucocorticoids \\[\\> 10 mg\u002F day equivalent dose of prednisone\\], alpha-interferon, immunoglobulin, cyclophosphamide, cyclosporin, etc.) used within 14 days prior to the first administration of the study drug or planned during the study period were allowed to be inhaled, nasal spray, or topical corticosteroids;\n24. Those who had been vaccinated within 4 weeks prior to initial administration of the study drug; Or who plan to be vaccinated during PK blood collection (only for subjects in the PK subgroup);\n25. Plan to have a child or sperm donation during the entire trial period and within 3 months after the last dose, or do not want to use effective physical contraception (such as condoms, diaphragms, Iuds, etc.);\n26. Have other serious medical conditions that the researchers said could not benefit from them\n27. Subjects deemed unsuitable by other investigators.","MALE","12 Years","65 Years",{"count":259,"type":260},60,"ESTIMATED","INTERVENTIONAL",[263],"PHASE3","The indication for this product is to control and prophylaxis in patients with Hemophilia A (congenital Factor VIII deficiency):\n\nThe Primary Objective： To evaluate the efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) for prophylactic treatment in previously treated patients with severe Hemophilia A.\n\nSecondary Objectives： To evaluate the health-related quality of life, pharmacokinetic (PK) profiles, safety and immunogenicity of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) for prophylactic treatment in previously treated subjects with severe Hemophilia A.",[266],"Severe Hemophilia A","2026-06-29",{"date":269,"type":270},"2026-07-06","ACTUAL",{"date":272,"type":270},"2026-06-12",{"date":274,"type":260},"2027-06-21",{"name":5,"class":6},19]