New clotting factor aims to stop bleeding in severe hemophilia a
NCT ID NCT07663903
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This phase 3 trial tests a new drug called FRSW107, a lab-made clotting factor VIII fused with a protein that helps it last longer in the body. The study enrolls males aged 12 to 65 with severe hemophilia A who have had at least 150 prior exposure days to factor VIII products. Participants receive FRSW107 on demand to control bleeding episodes over six months, and researchers measure how well it stops bleeding, its safety, and the body's immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant human coagulation factor VIII-Fc fusion protein (FRSW107)
- What this could lead to
- If successful, this could provide a new on-demand treatment option to control bleeding episodes in people with severe hemophilia A.
- What could go wrong
- This is a single-arm, open-label trial with only 60 participants, so results may not generalize. Risks include allergic reactions or development of inhibitors that block the treatment's effect.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- 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.
Inclusive Criteria: 1. Males aged 12 or younger to 65 years old. 2. Patients clinically diagnosed with severe hemophilia A, i.e., those confirmed through screening or previous medical records: FⅧ Activity \< 1%. 3. 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). 4. 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. 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); or Serum 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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Fujian Medical University Union Hospital
Fuzhou, China
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Fuyang Hospital, Affiliated to Anhui Medical University
Fuyang, China
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Ganzhou People's Hospital
Ganzhou, China
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Henan Cancer Hospital
Zhengzhou, China
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Huai'an Second People's Hospital
Huai'an, China
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Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, 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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North China University of Science and Technology Affiliated Hospital
Tangshan, China
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Qinghai Provincial People's Hospital
Qinghai, China
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Rizhao People's Hospital
Rizhao, China
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Subei People's Hospital of Jiangsu province
Yangzhou, China
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The First Affiliated Hospital of Guangxi Medical University
Nanning, China
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The First Affiliated Hospital of Nanyang Medical College
Nanyang, China
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The Second Affiliated Hospital of Kunming Medical University
Kunming, China
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The Second Hospital of Hebei Medical University
Shijiazhuang, China
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The Second Hospital of Shanxi Medical University
Taiyuan, China
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Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology.
Wuhan, China
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Wenzhou People's Hospital
Wenzhou, China
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Xi'an Central Hospital
Xi'an, China
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Zhengzhou People's Hospital
Zhengzhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Once-Weekly shot cut the burden of hemophilia a?
- Once-a-Week shot aims to stop bleeds in severe hemophilia a
- A Once-a-Week shot could transform hemophilia Care—Even for those with inhibitors
- Can a new clotting factor offer better bleed protection for severe hemophilia?
- New clotting factor aims to cut bleeding episodes in severe hemophilia a
- Monthly shot could free kids with hemophilia from frequent infusions