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)
NCT ID NCT06142552
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
To evaluate the prophylactic efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. To evaluate the safety of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. Secondary purpose: To 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. To evaluate the pharmacokinetic (PK) characteristics of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A. To evaluate the immunogenicity of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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124 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 65 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
inclusion Criteria： * 12≤ age ≤65 year-old men; * Patients with clinically confirmed severe hemophilia A, i.e. at screening (central laboratory testing) or previous medical records confirm: FⅧ activity \< 1%； * Previous documented treatment with any recombinant and/or blood-derived coagulation factor Ⅷ products or cryoprecipitation products and dosed ≥150 exposure days (EDs≥150) * Normal prothrombin time (PT) or International Normalized Ratio (INR)\<1.3 * Bleeding events were recorded in detail for at least 6 months prior to screening（Participants in the on demand /PPX group were required to have at least 6 episodes of spontaneous bleeding within 6 months） * Fully understand and know about this study and sign informed consent to participate in the clinical study voluntarily, subject and/or their guardian can cooperate with them for bleeding treatment at home, and have the ability to complete all study procedures Exclusion Criteria: 1. Known or suspected allergy to the investigational drug or its excipients, including mouse or hamster proteins; 2. Hypersensitivity or anaphylaxis after FⅧ or IgG2 injection in the past; 3. FⅧ inhibitor positive (≥0.6 BU/mL) during the screening period, or have a history of FⅧ inhibitor positive in the past, or a family history of FⅧ inhibitor positive; 4. Von Willebrand factor (vWF) antigen test results were lower than the lower limit of normal value; 5. Severe anemia at the screening stage (hemoglobin \< 60 g/L); 6. Platelet count during screening period \< 100×109 /L; 7. 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; 8. Patients with abnormal renal function: Creatinine clearance (Ccr) \<50 ml/min (according to Cockcroft and Gault formula); orSerum creatinine (Cr) \>1.5x ULN; 9. 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); 10. Patients with coagulation dysfunction other than hemophilia A; 11. Have a medical condition that may increase the risk of bleeding; 12. A history of drug or alcohol abuse; 13. Have a known mental disorder that may affect trial compliance; 14. Patients who have received transfusions of blood or blood components within 4 weeks prior to screening; 15. Participants who had participated in other clinical trials within 1 month before screening; 16. 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; 17. 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. 18. Study patients who had used emesezumab within 6 months prior to first administration of the drug; 19. 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; 20. Study patients who underwent major surgery within 3 months prior to initial drug administration (major surgery is defined in 6.2.3 Perioperative management); 21. 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); 22. Study patients with fever, severe active bacterial or viral infection, and allergies within 2 weeks before the first administration of the drug; 23. Systemic immunomodulators (such as glucocorticoids \[\> 10 mg/ day equivalent dose of prednisone\], 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; 24. 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); 25. 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.); 26. Have other serious medical conditions that the researchers said could not benefit from them 27. Subjects deemed unsuitable by other investigators.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Affiliated Hospital of Jiangnan University
Wuxi, China
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Affiliated Hospital of Nantong University
Nantong, China
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Anhui Provincial Hospital
Hefei, China
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Beijing tongren hospital,CMU
Beijing, China
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Fujian Medical University Union Hospital
Fuzhou, China
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Henan Cancer Hospital
Zhengzhou, China
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Henan Provincial People's Hospital
Zhengzhou, China
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Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China
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Jiangxi Provincial People's Hospital
Nanchang, China
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Jinan central hospital
Jinan, China
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Nanfang Hospital of Southern Medical University
Guangzhou, China
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Nanjing Drum Tower Hospital
Nanjing, China
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North China University of Science and Technology Affiliated Hospital
Tangshan, China
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Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, China
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Shenzhen Second People's Hospital
Shenzhen, China
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Subei People's Hospital of Jiangsu province
Yangzhou, China
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The Affiliated Hospital of Qingdao University
Qingdao, China
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The First Affiliated Hospital of Shandong First Medical University
Jinan, China
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The First Affiliated Hospital of Soochow University
Suzhou, China
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The First Affiliated Hospital of Xiamen University
Xiamen, China
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The First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, China
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The First Hospital of Lanzhou University
Lanzhou, China
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
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The Second Affiliated Hospital of Kunming Medical University
Kunming, China
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The Second Hospital of Shanxi Medical University
Taiyuan, China
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XiangYa Hospital CentralSouth University
Changsha, China
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Zhengzhou People's Hospital
Zhengzhou, China
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Zhenyu Li
Xuzhou, China
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Other studies related to the condition(s) this trial covers.
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