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Guo",{"type":301,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100644439","phase-3-study-of-recombinant-human-coagulation-factor-viii-fc-fusion-protein-frsw107-on-demand-treatment-100644439",false,"NCT07663903","Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) On-Demand Treatment","A Single-arm, Open-label, Multicenter Phase III Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) On-demand Treatment in Patients With Severe Hemophilia A (Adults and Adolescents) .","Inclusive Criteria:\n\n1. Males aged 12 or younger to 65 years old.\n2. Patients clinically diagnosed with severe hemophilia A, i.e., those confirmed through screening or previous medical records: FⅧ Activity \\\u003C 1%.\n3. Previous records confirm receipt of any recombinant and\u002For blood-derived coagulation factor VIII products or cold precipitate products, with a treatment of ≥150 exposure days (EDs ≥150).\n4. The participants have fully understood and been informed of this study, signed the informed consent form, and voluntarily enrolled in the clinical trial. The trial participants and\u002For their guardians are capable of cooperating with the hemostatic treatment 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 \\< 60 g\u002FL);\n6. Platelet count during screening period \\< 100×109 \u002FL;\n7. Abnormal liver function:\n\n   .Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \\>3 times upper limit of normal (ULN); or Serum total bilirubin (TBIL) \\>1.5x ULN;\n8. Patients with abnormal renal function:\n\n   Creatinine clearance (Ccr) \\\u003C50 ml\u002Fmin (according to Cockcroft and Gault formula); or Serum creatinine (Cr) \\>1.5x ULN;\n9. People 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. Patients 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. Patients who have received transfusions of blood or blood components within 4 weeks prior to screening;\n15. Participants who had participated in other 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 patients 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. Study patients who had used emesezumab within 6 months prior to first administration of the drug;\n19. Patients who had used monoclonal antibody therapy, Fc fusion protein products (except FRSW107 and FRSW117), PEG products (except FRSW117), or intravenous immunoglobulin infusion within 3 months before the first administration of the investigational drug;\n20. Study patients who underwent major surgery within 3 months prior to initial drug administration (major surgery is defined in 6.2.3 Perioperative management);\n21. Study patients who have used FⅧ preparation of any standard half-life (e.g., Bycoch, Coproch, Biinidin, Renjie, NoL, Antaine, etc.) within 3 days or 5 half-lives prior to first administration of the drug (taking the elderly); Patients who have used any other extended half-life preparation FⅧ within 4 days or 5 half-lives prior to first dosing (for the elderly);\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":313,"type":314},60,"ESTIMATED","INTERVENTIONAL",[317],"PHASE3","The indication for this product is to control bleeding in patients with hemophilia A (congenital deficiency of factor VIII).\n\nThe primary objective:\n\nEvaluation of the efficacy of recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW107) as an on-demand treatment in previously treated patients with severe hemophilia A.\n\nSecondary objectives:\n\nEvaluation of the safety and immunogenicity of FRSW107 as an on-demand therapy in previously treated patients with severe hemophilia A.\n\nEvaluate the on-demand treatment's PK profile of FRSW107 in previously treated patients with severe hemophilia A based on population pharmacokinetic (PopPK) methods ; preliminarily investigate the exposure-response (E-R) relationship of FRSW107 on-demand treatment in these patients if data permit.",[320],"Severe Hemophilia A","2026-06-17",{"date":323,"type":324},"2026-06-23","ACTUAL",{"date":326,"type":324},"2026-04-14",{"date":328,"type":314},"2027-06",{"name":5,"class":6},24]