Severe Hemophilia APhase 3NCT06142552

Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein

A Phase 3 study testing FRSW117 in people with Severe Hemophilia A, run by Hangzhou Gensciences Biopharmaceutical Co., Ltd. at 28 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To evaluate the prophylactic efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. To evaluate the safety of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. 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?: FRSW117
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 28 sitesChina
Study dates: 27 Dec 2023to 19 Oct 2025
Phase: Phase 3
Are there results?: None posted in the registry

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

12≤ age ≤65 year-old men;
Patients with clinically confirmed severe hemophilia A, i.e. at screening (central laboratory testing) or previous medical records confirm: FⅧ activity < 1%；
Previous documented treatment with any recombinant and/or blood-derived coagulation factor Ⅷ products or cryoprecipitation products and dosed ≥150 exposure days (EDs≥150)
Normal prothrombin time (PT) or International Normalized Ratio (INR)<1.3
Bleeding events were recorded in detail for at least 6 months prior to screening（Participants in the on demand /PPX group were required to have at least 6 episodes of spontaneous bleeding within 6 months）
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

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;

Show all 29Show fewer

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); orSerum 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

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

China28 sites

Beijing tongren hospital,CMU
Beijing
XiangYa Hospital CentralSouth University
Changsha
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Fujian Medical University Union Hospital
Fuzhou
Nanfang Hospital of Southern Medical University
Guangzhou
The First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou
Anhui Provincial Hospital
Hefei
Jinan central hospital
Jinan
The First Affiliated Hospital of Shandong First Medical University
Jinan
The Second Affiliated Hospital of Kunming Medical University
Kunming
The First Hospital of Lanzhou University
Lanzhou
Jiangxi Provincial People's Hospital
Nanchang
Nanjing Drum Tower Hospital
Nanjing
Affiliated Hospital of Nantong University
Nantong
The Affiliated Hospital of Qingdao University
Qingdao
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai
Shenzhen Second People's Hospital
Shenzhen
The First Affiliated Hospital of Soochow University
Suzhou
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
Affiliated Hospital of Jiangnan University
Wuxi
The First Affiliated Hospital of Xiamen University
Xiamen
Zhenyu Li
Xuzhou
Subei People's Hospital of Jiangsu province
Yangzhou
Henan Cancer Hospital
Zhengzhou
Henan Provincial People's Hospital
Zhengzhou
Zhengzhou People's Hospital
Zhengzhou

Other trials in China

About this study

Official title: Multicenter Study to Evaluate the Efficacy, Safety, Immunogenicity, and Pharmacokinetics of Recombinant Human Coagulation Factor Ⅷ-Fc Fusion Protein (FRSW117) for Injection in Patients With Severe Hemophilia A (Adults and Adolescents)

To evaluate the prophylactic efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A.

To evaluate the safety of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A.

Secondary purpose:

To evaluate the efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein for injection (FRSW117) in hemostasis and surgical hemostasis in patients with severe hemophilia A.

To evaluate the pharmacokinetic (PK) characteristics of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.

To evaluate the immunogenicity of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.

Conditions: Severe Hemophilia A
Being tested: FRSW117
Keywords: Pharmacokinetics, Safety, immunogenicity, effectiveness
Medical subject headings: Hemophilia A

What participants receive

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

FRSW117Drug
Also called Recombinant human coagulation factor Ⅷ-Fc fusion protein for injection
once a week, 50 weeks and as needed

Study groups in NCT06142552
Study group	Role	What they receive
Prevention and Treatment Group (PPX group)	Experimental	Subjects received single and multiple doses of 50 IU/kg FRSW117 at first administration of V1 (D1), V4 (18w), and V7 (50w), and PK samples were collected until 168 h post-administration, respectively. During prophylaxis, FRSW117 is used for breakthrough therapy if the subject has a breakthrough bleeding event (i.e., a bleeding event during prophylaxis) that requires treatment. Receives: Drug: FRSW117
On Demand/Preventive Treatment Group (On Demand /PPX Group)	Experimental	The appropriate dose and frequency of administration of FRSW117 is recommended until bleeding events are controlled or returned to pre-bleeding activity. Receives: Drug: FRSW117
Perioperative management	Experimental	Patients in the PPX and on demand /PPX groups will be allowed to undergo surgery (both major and minor) during the main trial period (prior to 50w), while FRSW117 will be administered perioperatively Receives: Drug: FRSW117

What is being measured

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

ABR
Annual rate of bleeding (ABR) during preventive treatment = Number of bleeding during the efficacy evaluation period/(number of treatment days /365.25)
Measured: 1year
Effective rate of bleeding treatment
The hemostatic effect was evaluated according to a four-level scoring scale, including breakthrough bleeding treatment during preventive treatment and on-demand treatment during on-demand treatment
Measured: 2year
Safety evaluation
Incidence of positive FⅧ inhibitor.
Adverse events/Adverse events: Adverse events during treatment (TEAE), serious Adverse events (SAEs), adverse events of particular concern (AESI), occurrences of adverse events that cause subjects to discontinue medication, drop out of the study, and death, and occurrences of the above metrics associated with the investigational drug.
Injection site reaction.
Laboratory tests: blood routine, urine routine, blood biochemistry, coagulation function, virology and immune function tests.
Thrombosis markers.
Vital signs, physical examination, neurological examination, 12-lead electrocardiogram, surgery-related complications.
PEG level.
Measured: 3year
Adverse events/reactions
Adverse events during treatment (TEAE), serious Adverse events (SAEs), with a special focus on adverse events (AESI), adverse events that cause subjects to discontinue medication, drop out of the study, and die, etc.
Measured: ALL
Immunogenicity evaluation
The positive rate of anti-FRSW117 antibody, anti-PEG antibody and anti-CHO antibody; When the anti-FRSW117 antibody was positive, the anti-RHFVIII antibody and anti-PEG antibody were further detected to evaluate the positive incidence
Measured: ALL

Timeline

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

27 Dec 202319 Oct 2025

First posted21 Nov 2023
Study start27 Dec 2023
Primary completion8 Oct 2025
Study completion19 Oct 2025

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06142552
Sponsor's protocol ID: SS-117-III01
Status last verified: Feb 2024
First submitted: 7 Nov 2023
Last updated: 9 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?

See locations

RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
Active, not recruitingPhase 4
A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis
Severe Hemophilia A, Moderate Hemophilia A
Not yet recruitingObservational study
Post Approval Phase 4 Study to Learn More About How Safe Octocog Alfa is, and How Well it Works in Patients With Severe Hemophilia A in India
Severe Hemophilia A

All Severe Hemophilia A trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Study to Evaluate the Efficacy, Safety, Immunogenicity, and Pharmacokinetics of Recombinant Human Coagulation Factor Ⅷ-Fc Fusion Protein (FRSW117) for Injection in Patients With Severe Hemophilia A (Adults and Adolescents)
ClinicalTrials.gov ID: NCT06142552
Acronym / sponsor ID: SS-117-III01
Conditions: Severe Hemophilia A
Keywords: Pharmacokinetics, Safety, immunogenicity, effectiveness
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Hangzhou Gensciences Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 27 Dec 2023 (actual)
Primary completion: 8 Oct 2025 (actual)
Study completion: 19 Oct 2025 (actual)
First posted: 21 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the prophylactic efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A.

To evaluate the safety of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A.

Secondary purpose:

To evaluate the efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein for injection (FRSW117) in hemostasis and surgical hemostasis in patients with severe hemophilia A.

To evaluate the pharmacokinetic (PK) characteristics of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.

To evaluate the immunogenicity of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Prevention and Treatment Group (PPX group)	Experimental	Drug: FRSW117Subjects received single and multiple doses of 50 IU/kg FRSW117 at first administration of V1 (D1), V4 (18w), and V7 (50w), and PK samples were collected until 168 h post-administration, respectively. During prophylaxis, FRSW117 is used for breakthrough therapy if the subject has a breakthrough bleeding event (i.e., a bleeding event during prophylaxis) that requires treatment.
On Demand/Preventive Treatment Group (On Demand /PPX Group)	Experimental	Drug: FRSW117The appropriate dose and frequency of administration of FRSW117 is recommended until bleeding events are controlled or returned to pre-bleeding activity.
Perioperative management	Experimental	Drug: FRSW117Patients in the PPX and on demand /PPX groups will be allowed to undergo surgery (both major and minor) during the main trial period (prior to 50w), while FRSW117 will be administered perioperatively

Who may qualify

Ages: 12 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

12≤ age ≤65 year-old men;
Patients with clinically confirmed severe hemophilia A, i.e. at screening (central laboratory testing) or previous medical records confirm: FⅧ activity < 1%；
Previous documented treatment with any recombinant and/or blood-derived coagulation factor Ⅷ products or cryoprecipitation products and dosed ≥150 exposure days (EDs≥150)
Normal prothrombin time (PT) or International Normalized Ratio (INR)<1.3
Bleeding events were recorded in detail for at least 6 months prior to screening（Participants in the on demand /PPX group were required to have at least 6 episodes of spontaneous bleeding within 6 months）

Key exclusion criteria (29 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FRSW117Also: Recombinant human coagulation factor Ⅷ-Fc fusion protein for injectiononce a week, 50 weeks and as needed	Drug	On Demand/Preventive Treatment Group (On Demand /PPX Group), Perioperative management, Prevention and Treatment Group (PPX group)

Primary outcome

ABR
Time frame: 1year
Annual rate of bleeding (ABR) during preventive treatment = Number of bleeding during the efficacy evaluation period/(number of treatment days /365.25)
Effective rate of bleeding treatment
Time frame: 2year
The hemostatic effect was evaluated according to a four-level scoring scale, including breakthrough bleeding treatment during preventive treatment and on-demand treatment during on-demand treatment
Safety evaluation
Time frame: 3year
Incidence of positive FⅧ inhibitor. Adverse events/Adverse events: Adverse events during treatment (TEAE), serious Adverse events (SAEs), adverse events of particular concern (AESI), occurrences of adverse events that cause subjects to discontinue medication, drop out of the study, and death, and occurrences of the above metrics associated with the investigational drug. Injection site reaction. Laboratory tests: blood routine, urine routine, blood biochemistry, coagulation function, virology and immune function tests. Thrombosis markers. Vital signs, physical examination, neurological examination, 12-lead electrocardiogram, surgery-related complications. PEG level.
Adverse events/reactions
Time frame: ALL
Adverse events during treatment (TEAE), serious Adverse events (SAEs), with a special focus on adverse events (AESI), adverse events that cause subjects to discontinue medication, drop out of the study, and die, etc.
Immunogenicity evaluation
Time frame: ALL
The positive rate of anti-FRSW117 antibody, anti-PEG antibody and anti-CHO antibody; When the anti-FRSW117 antibody was positive, the anti-RHFVIII antibody and anti-PEG antibody were further detected to evaluate the positive incidence

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.

Related trials for Severe Hemophilia A

RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
Active, not recruitingPhase 4
A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis
Severe Hemophilia A, Moderate Hemophilia A
Not yet recruitingObservational study
Post Approval Phase 4 Study to Learn More About How Safe Octocog Alfa is, and How Well it Works in Patients With Severe Hemophilia A in India
Severe Hemophilia A

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Renchi Yang study chair

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

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FRSW117 in people with Severe Hemophilia A, run by Hangzhou Gensciences Biopharmaceutical Co., Ltd. at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ABR (time frame: 1year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06142552.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.