Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) as Prophylactic Treatment.

Recruiting now · Phase 3

Conditions studied: Severe Hemophilia A

In brief

The indication for this product is to control and prophylaxis in patients with Hemophilia A (congenital Factor VIII deficiency): The 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. Secondary 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.

Key facts

Study ID

NCT07684898

Run by

Hangzhou Gensciences Biopharmaceutical Co., Ltd.

People needed

60

Starts

2026-06-12

Expected to finish

2027-06-21

Last updated by the study team

2026-07-06

Who can join

Age: 12 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 1%; 3.Previous documented treatment with any recombinant and/or 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)<1.3; 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/or their guardian can cooperate with them for bleeding treatment at home, and have the ability to complete all study procedures

You may not qualify if…

• Known or suspected allergy to the investigational drug or its excipients, including mouse or hamster proteins;
• Hypersensitivity or anaphylaxis after FⅧ or IgG2 injection in the past;
• 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;
• Von Willebrand factor (vWF) antigen test results were lower than the lower limit of normal value;
• Severe anemia at the screening stage (hemoglobin < 60 g/L);
• Platelet count during screening period < 100×109 /L;
• 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;
• Subjects with abnormal renal function: Creatinine clearance (Ccr) <50 ml/min (according to Cockcroft and Gault formula); or Serum creatinine (Cr) >1.5x ULN;
• 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);
• Subjects with coagulation dysfunction other than hemophilia A;
• Have a medical condition that may increase the risk of bleeding;
• A history of drug or alcohol abuse;
• Have a known mental disorder that may affect trial compliance;
• Subjects who have received transfusions of blood or blood components within 4 weeks prior to screening;
• Participants who had participated in other Interventional clinical trials within 1 month before screening;
• 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;
• 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.
• 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;
• 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;
• 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;
• 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;
• Study patients with fever, severe active bacterial or viral infection, and allergies within 2 weeks before the first administration of the drug;
• 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;
• 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);
• 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.);

Where it is running

• Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, Tianjin Municipality, China (enrolling)
• Fuyang Hospital, Affiliated to Anhui Medical University — Fuyang, China
• Fujian Medical University Union Hospital — Fuzhou, China
• Nanfang Hospital of Southern Medical University — Guangzhou, China
• Anhui Provincial Hospital — Hefei, China
• Jinan central hospital — Jinan, China
• The Second Affiliated Hospital of Kunming Medical University — Kunming, China
• The First Affiliated Hospital of Guangxi Medical University — Nanning, China
• Affiliated Hospital of Nantong University — Nantong, China
• The First Affiliated Hospital of Nanyang Medical College — Nanyang, China
• Qinghai Provincial People's Hospital — Qinghai, China
• The Second Hospital of Shanxi Medical University — Taiyuan, China
• North China University of Science and Technology Affiliated Hospital — Tangshan, China
• Wenzhou People's Hospital — Wenzhou, China
• Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology. — Wuhan, China
• Affiliated Hospital of Jiangnan University — Wuxi, China
• Xi'an Central Hospital — Xi'an, China
• Henan Cancer Hospital — Zhengzhou, China
• Zhengzhou People's Hospital — Zhengzhou, China

Full record on ClinicalTrials.gov

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