NCT07663903Active, not recruitingPhase 3

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) .

Source: ClinicalTrials.gov · Last updated 8 Sept 2026

Brief summary (registry, in English)

The indication for this product is to control bleeding in patients with hemophilia A (congenital deficiency of factor VIII). The primary objective: Evaluation 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. Secondary objectives: Evaluation of the safety and immunogenicity of FRSW107 as an on-demand therapy in previously treated patients with severe hemophilia A. Evaluate 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.

Status (registry): Active, not recruiting
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 60 (estimated)
First submitted: 15 Jun 2026
Start date: 14 Apr 2026
Primary completion date: Feb 2027
Lead sponsor: Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Diseases: Haemophilia
NCT number: NCT07663903

What you commit to

Study type: Interventional · Phase 3
Planned participants: 60
From 14 Apr 2026 to the primary completion date, Feb 2027
24 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Known or suspected allergy to the investigational drug or its excipients, including mouse or hamster proteins;
Patients who have received transfusions of blood or blood components within 4 weeks prior to screening;
Participants who had participated in other 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 patients who need to be treated with anticoagulant or antiplatelet drugs or off-label maximum doses of SAID during clinical trials;
Study patients who had used emesezumab within 6 months prior to first administration of the drug;
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;
Study patients who underwent major surgery within 3 months prior to initial drug administration (major surgery is defined in 6.2.3 Perioperative management);
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);
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);

Other illness

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;
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);
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;
Have other serious medical conditions that the researchers said could not benefit from them

Lab values

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;
Patients with abnormal renal function:
- Creatinine clearance (Ccr) \<50 ml/min (according to Cockcroft and Gault formula); or Serum creatinine (Cr) \>1.5x ULN;
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.

Other

Von Willebrand factor (vWF) antigen test results were lower than the lower limit of normal value;
Patients with coagulation dysfunction other than hemophilia A;
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.);
Subjects deemed unsuitable by other investigators.

Criteria the registry did not label

Inclusive Criteria:
Males aged 12 or younger to 65 years old.
Patients clinically diagnosed with severe hemophilia A, i.e., those confirmed through screening or previous medical records: FⅧ Activity \< 1%.
Previous records confirm receipt of any recombinant and/or blood-derived coagulation factor VIII products or cold precipitate products, with a treatment of ≥150 exposure days (EDs ≥150).
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/or their guardians are capable of cooperating with the hemostatic treatment and have the ability to complete all study procedures.

Age in the registry: 12 years to 65 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Fuyang Hospital Affiliated to Anhui Medical University Coordinator of this site? Confirm its status	Fuyang	China	Unknown status
Fujian Medical University Union Hospital Coordinator of this site? Confirm its status	Fuzhou	China	Unknown status
Ganzhou People's Hospital Coordinator of this site? Confirm its status	Ganzhou	China	Unknown status
Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status	Guangzhou	China	Unknown status
Anhui Provincial Hospital Coordinator of this site? Confirm its status	Hefei	China	Unknown status
Huai'an Second People's Hospital Coordinator of this site? Confirm its status	Huai'an	China	Unknown status
Jinan Central Hospital Coordinator of this site? Confirm its status	Jinan	China	Unknown status
The Second Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status	Kunming	China	Unknown status
The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status	Nanning	China	Unknown status
Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status	Nantong	China	Unknown status
The First Affiliated Hospital of Nanyang Medical College Coordinator of this site? Confirm its status	Nanyang	China	Unknown status
Qinghai Provincial People's Hospital Coordinator of this site? Confirm its status	Qinghai	China	Unknown status
Rizhao People's Hospital Coordinator of this site? Confirm its status	Rizhao	China	Unknown status
The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status	Shijiazhuang	China	Unknown status
The Second Hospital of Shanxi Medical University Coordinator of this site? Confirm its status	Taiyuan	China	Unknown status
North China University of Science and Technology Affiliated Hospital Coordinator of this site? Confirm its status	Tangshan	China	Unknown status
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Coordinator of this site? Confirm its status	Tianjin	China	Unknown status
Wenzhou People's Hospital Coordinator of this site? Confirm its status	Wenzhou	China	Unknown status
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status	Wuhan	China	Unknown status
Affiliated Hospital of Jiangnan University Coordinator of this site? Confirm its status	Wuxi	China	Unknown status
Xi'an Central Hospital Coordinator of this site? Confirm its status	Xi’an	China	Unknown status
Subei People's Hospital of Jiangsu province Coordinator of this site? Confirm its status	Yangzhou	China	Unknown status
Zhengzhou People's Hospital Coordinator of this site? Confirm its status	Zhengzhou	China	Unknown status
Henan Cancer Hospital Coordinator of this site? Confirm its status	Zhengzhou	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.