[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangsu Gensciences lnc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100526574","phase-3-study-of-efficacy-and-safety-of-frsw107-in-pediatric-patients-with-severe-hemophilia-a-100526574",false,"NCT06136507","Study of Efficacy and Safety of FRSW107 in Pediatric Patients With Severe Hemophilia A","An Open, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Coagulation Factor Ⅷ-Fc Fusion Protein (FRSW107) for Injection in Pediatric Patients With Severe Hemophilia A","Inclusion Criteria:\n\n1. Children \\\u003C12 years old, male;\n2. Weight \\>10kg;\n3. clinically confirmed patients with severe hemophilia A (defined as confirmation at the time of screening or previous medical records: coagulation factor VI activity \\\u003C1%);\n4. Treated patients, that is, those who had previously received EVI treatment and met the following criteria: \\\u003C6 years old patients who had been treated with coagulation factor VI for \\>50 exposure days (EDs250), and \\\u003C 26 years old patients who had been treated with coagulation factor VI for \\>150 exposure days(\\> 150);\n5. Normal prothrombin time (PT) or International normalized ratio (INR) \\\u003C1.3;\n6. At least 6 months of treatment and detailed records of bleeding events before screening;\n7. The subject's legally authorized representative (i.e. guardian) fully understands and knows about this study and signs the informed consent. Children with the ability to give informed consent (≥8 years old) should be informed and sign the informed consent voluntarily;\n\nExclusion Criteria:\n\n1\\. People who have been allergic to any component of EVI preparation (including but not limited to mouse or hamster protein or virus vaccine, gene recombination preparation containing mouse or hamster protein, etc.); Those who have had serious adverse reactions to previous vaccine injections or have not recovered from mild to moderate adverse reactions to vaccine injections; 2.Patients with hypersensitivity or anaphylaxis after injection of coagulation factor VI or Fc fusion protein products; 3. Positive factor VI inhibitor at screening (20.6 BU\u002FmL), or previous history of factor VI inhibitor, or family history of inhibitor; 4.the screening results of von Willebrand factor (vWE) antigen were lower than the lower limit of normal value; 5. Severe anemia (hemoglobin \\\u003C60g\u002FL) at the time of screening; 6. Platelet count \\\u003C100×10⁹ during screening \u002FL; 7.abnormal liver function: alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \\>3 times the upper limit of normal (ULN); Serum bilirubin (TBIL\\>3× ULN; 8. Patients with abnormal renal function: serum creatinine (SCr) \\>1.5×ULN or according toCreatinine clearance calculated by Cockcroft-Gault formula \\< 60 mL\u002Fmin (CTCAE Level 1); 9. hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus antibody (Anti-HIV) and anti-treponema pallidum specific antibody (Anti-TP) test has one or more positive; 10. Patients with coagulation dysfunction other than hemophilia A; 11,.have other medical conditions that may increase the risk of bleeding or blood clots; 12. Have a known mental disorder that may affect trial compliance; 13. Patients who have used EV preparations of any standard half-life (e.g., Bekochi, Koyuki, Biinstop, Renjie, etc.) within 3 days or 5 half-lives prior to the first dose; Patients who have used any other half-life extension FVI preparations within 4 days or 5 half-lives prior to dosing (older at the time of retrieval); 14. Patients who have used emesezumab within 6 months prior to first dosing; 15. Severe cardiovascular and cerebrovascular disease, such as cerebral arteritis, moyamoya disease, stroke, viral myocarditis, endocarditis, endocardial fibroplasia, severe arrhythmia, congestive heart failure (New York Heart Association grade \\> III), uncontrolled hypertension, thromboembolic disease, and uncontrolled diabetes, occurred within 6 months prior to the first medication; 16. Patients who had used monoclonal antibody therapy, Fc fusion protein products, or intravenous immunoglobulin within 3 months before the first dose; 17.those who underwent major surgical procedures and transfusions of blood or blood components within 4 weeks prior to initial dosing, or who plan to undergo elective surgery (other than minor surgery such as tooth extraction) during the study treatment period; Those who underwent major surgical procedures and transfusions of blood or blood components within 4 weeks prior to initial dosing, or who plan to undergo elective surgery during the study treatment period; 18.patients with fever, active infection, allergies (such as allergic rhinitis, allergic asthma, allergic dermatitis, etc.) within 2 weeks prior to the first dose； 19.people with immune deficiency diseases or autoimmune diseases such as systemic lupus erythematosus, or have a history of organ transplantation or stem cell transplantation; Systemic immunomodulators (such as corticosteroids (\\>10mg\u002F day equivalent dose of prednisone), alpha-interferon, immunoglobulin, cyclophosphamide, cyclosporin, etc.) used within 14 days prior to the first administration or planned during the study period were allowed to use inhaled, nasal, ocular, intraarticular or topical corticosteroids; 20.patients who were treated with any anticoagulation (other than heparin sealing treatment) or platelet aggregation inhibitors within 7 days prior to initial administration or who required anticoagulation (other than heparin sealing treatment) or platelet aggregation inhibitors during study therapy; 21. Participants who have participated in other clinical trials within 1 month before screening; 22.had other serious medical conditions from which the researchers did not believe they could benefit; He suffered from severe skin disease, which interfered with the observation of local injection reaction.\n\n23\\. Subjects deemed unsuitable by other investigators.","MALE","1 Year","12 Years",{"count":20,"type":21},76,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study was divided into four stages: screening period, main trial period, extension period and follow-up period.\n\nIn the main trial, both groups received FRSW107 prophylactic therapy. The recommended initial dose of prophylactic administration was 50 IU\u002Fkg, the dose range was 25 to 50 IU\u002Fkg, and the recommended frequency of administration was once every three days (Q3D). The dose range could be adjusted according to the patient's response. The main trial period was prophylaxis up to ≥50 exposure days (EDs) and ≥6 months.\n\nThe investigator may adjust the dose according to the clinical efficacy of the subjects (the occurrence of bleeding and its clinical manifestations) and the concentration of FⅧ valley according to the following principles.\n\nIf necessary, the investigator may adjust the dosing interval according to the clinical efficacy of the subject (the occurrence of bleeding and its clinical manifestations) and the concentration of FⅧ. Investigators are advised to inform sponsors or their research partners when adjusting doses and dosing intervals during prophylaxis.\n\nAfter participants completed prophylaxis until ≥50EDs and ≥6 months, participants' willingness and investigator evaluation were used to decide whether to enter the extended trial. All subjects entering the extended phase continued with the original prophylactic regimen until 100EDs was dosed.\n\nDuring the main trial period and the extended preventive treatment period, if the subjects have breakthrough bleeding events requiring treatment, hemostatic treatment of breakthrough bleeding with investigational drugs can be performed. The researchers can refer to the treatment guidance for different degrees of bleeding in Table 6-1. Taking into account the subject's prophylactic dose, severity of bleeding, site and extent of bleeding, clinical status, and previous PK results (if any), the investigator determines the appropriate dose to administer (recommended dose range: 25 to 50 IU\u002Fkg) and dosing times until the investigator assessed significant control of bleeding episodes (e.g. reduction of pain and swelling) or return to pre-bleeding activity. If the bleeding episode stops, the subject will continue with the same dose and frequency of prophylactic medication as before the bleeding episode.",[27],"Severe Hemophilia A",[29,30,31,32,33],"safetyeffectiveness","immunogenicity","effectiveness","Children","Teenagers","NOT_YET_RECRUITING","2024-06-17",{"date":37,"type":38},"2024-06-20","ACTUAL",{"date":40,"type":21},"2026-12-25",{"date":42,"type":21},"2026-12-31",{"name":44,"class":45},"Jiangsu Gensciences lnc.","INDUSTRY",13,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100527037","phase-3-phase-3-clinical-project-of-pegylated-recombinant-human-coagulation-factor-viii-fc-fusion-protein-100527037","NCT06142552","Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein","Multicenter Study to Evaluate the Efficacy, Safety, Immunogenicity, and Pharmacokinetics of Recombinant Human Coagulation Factor Ⅷ-Fc Fusion Protein (FRSW117) for Injection in Patients With Severe Hemophilia A (Adults and Adolescents)","inclusion Criteria：\n\n* 12≤ age ≤65 year-old men;\n* Patients with clinically confirmed severe hemophilia A, i.e. at screening (central laboratory testing) or previous medical records confirm: FⅧ activity \\\u003C 1%；\n* Previous documented treatment with any recombinant and\u002For blood-derived coagulation factor Ⅷ products or cryoprecipitation products and dosed ≥150 exposure days (EDs≥150)\n* Normal prothrombin time (PT) or International Normalized Ratio (INR)\\\u003C1.3\n* Bleeding events were recorded in detail for at least 6 months prior to screening（Participants in the on demand \u002FPPX group were required to have at least 6 episodes of spontaneous bleeding within 6 months）\n* 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 \\< 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); orSerum 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.","65 Years",{"count":56,"type":21},120,[24],"To evaluate the prophylactic efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A.\n\nTo evaluate the safety of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A.\n\nSecondary purpose:\n\nTo evaluate the efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein for injection (FRSW117) in hemostasis and surgical hemostasis in patients with severe hemophilia A.\n\nTo evaluate the pharmacokinetic (PK) characteristics of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.\n\nTo evaluate the immunogenicity of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.",[27],[61,62,30,31],"Pharmacokinetics","Safety","RECRUITING","2024-02-27",{"date":66,"type":38},"2024-02-28",{"date":68,"type":38},"2023-12-27",{"date":70,"type":21},"2026-09-01",{"name":44,"class":45},28,""]