Severe Hemophilia APhase 3NCT07663903

Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) On-Demand Treatment

A Phase 3 study testing FRSW107 in people with Severe Hemophilia A, run by Hangzhou Gensciences Biopharmaceutical Co., Ltd. at 24 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 12 to 65 years, men only
Conditions the study is for: Severe Hemophilia A
What is being tested?: FRSW107
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 24 sitesChina
Study dates: 14 Apr 2026to Jun 2027
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 65 years
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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;

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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;
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);
Patients 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;
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;
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.
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);
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.);
Have other serious medical conditions that the researchers said could not benefit from them
Subjects deemed unsuitable by other investigators.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

China24 sites

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

Other trials in China

About this study

Official title: 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) .

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.

Conditions: Severe Hemophilia A
Being tested: FRSW107
Medical subject headings: Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FRSW107Drug
Treatment for 6 months as needed.

Study groups in NCT07663903
Study group	Role	What they receive
On-demand Treatment.	Experimental	On-demand treatment (recommended range: 20-50 IU/kg) Receives: Drug: FRSW107

What is being measured

The primary outcome is the main question the study is designed to answer.

The haemostatic effective rate
The haemostatic effect of FRSW107 when used for treatment of bleeds, assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) by counting excellent and good as success and moderate and none as failure.
Measured: 6 months

Secondary outcomes (7)

Number of infusions and IU/kg of FRSW107 needed for the treatment of bleeding episodes
Measured: 6 months
FVIII activity during on-demand: activity recovery rate
FVIII activity recovery rate on Day1's haemostatic therapy.
Measured: Visit1,Day1
Hemophilia Joint Health Score (HJHS 2.1) during on-demand treatment
total score and each subscale score of HJHS 2.1, as well as their changes over time.
Measured: 6 month
incidence of lack of drug efficacy
Lack of drug efficacy is defined as: during on-demand treatment, hemostatic efficacy is assessed as "ineffective" or "poor/no response" following two consecutive administrations within 72 hours for the same bleeding episode.
incidence of lack of drug efficacy=number of lack of drug efficacy/number of evaluated treatment*100%.
Measured: 6 months
Occurrence of AEs and SAEs
Measured: 6 month
Incidence rate of positive FVIII inhibitors
A positive FⅧ inhibitor is defined as a Bethesda inhibitor titer ≥ 0.6 BU/mL. Incidence rate of positive FVIII inhibitors=number of positive FⅧ inhibitors participant / total number of trial participants *100%.
Measured: 6 month
Incidence rate of positive ADA, Incidence rate of positive anti-CHO antibody
Incidence rate of positive ADA=number of positive ADA participant / total number of trial participants *100% Incidence rate of positive anti-CHO antibody=number of positive anti-CHO antibody participant / total number of trial participants *100%
Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 2026Jun 2027

First posted23 Jun 2026
Study start14 Apr 2026
Primary completionFeb 2027 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Severe Hemophilia AStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07663903
Sponsor's protocol ID: SS-107-III05
Status last verified: Jun 2026
First submitted: 15 Jun 2026
Last updated: 8 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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