Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New clotting factor aims to stop bleeding in severe hemophilia a

NCT ID NCT07663903

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

12 to 65 years

Sex

Male participants only

Healthy volunteers

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

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 \&lt; 60 g/L); 6. Platelet count during screening period \&lt; 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Severe hemophilia A are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Affiliated Hospital of Jiangnan University

    Wuxi, China

  • Affiliated Hospital of Nantong University

    Nantong, China

  • Anhui Provincial Hospital

    Hefei, China

  • Fujian Medical University Union Hospital

    Fuzhou, China

  • Fuyang Hospital, Affiliated to Anhui Medical University

    Fuyang, China

  • Ganzhou People's Hospital

    Ganzhou, China

  • Henan Cancer Hospital

    Zhengzhou, China

  • Huai'an Second People's Hospital

    Huai'an, China

  • Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College

    Tianjin, Tianjin Municipality, China

  • Jinan central hospital

    Jinan, China

  • Nanfang Hospital of Southern Medical University

    Guangzhou, China

  • North China University of Science and Technology Affiliated Hospital

    Tangshan, China

  • Qinghai Provincial People's Hospital

    Qinghai, China

  • Rizhao People's Hospital

    Rizhao, China

  • Subei People's Hospital of Jiangsu province

    Yangzhou, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, China

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, China

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, China

  • The Second Hospital of Shanxi Medical University

    Taiyuan, China

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology.

    Wuhan, China

  • Wenzhou People's Hospital

    Wenzhou, China

  • Xi'an Central Hospital

    Xi'an, China

  • Zhengzhou People's Hospital

    Zhengzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.