NCT07684898

Brief Summary

The indication for this product is to control and prophylaxis in patients with Hemophilia A (congenital Factor VIII deficiency): The Primary Objective： To evaluate the efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) for prophylactic treatment in previously treated patients with severe Hemophilia A. Secondary Objectives： To evaluate the health-related quality of life, pharmacokinetic (PK) profiles, safety and immunogenicity of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) for prophylactic treatment in previously treated subjects with severe Hemophilia A.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
10mo left

Started Jun 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jun 2026Jun 2027

Study Start

First participant enrolled

June 12, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2027

Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

June 16, 2026

Last Update Submit

June 29, 2026

Conditions

Severe Hemophilia A

Outcome Measures

Primary Outcomes (1)

  • ABR

    Annual rate of bleeding (ABR) during preventive treatment = Number of bleeding episode during the efficacy evaluation period/(number of treatment days /365.25)

    6 months

Secondary Outcomes (19)

  • Safety Evaluation

    6 months

  • Immunogenicity Evaluation

    6 months

  • Peak activity (Cmax)

    At Visit 1 (Day 0 through Day 4) and Visit 5 (Day 160 through Day 164).

  • Effective rate of hemostatic treatment

    6 months

  • Annualized rate of spontaneous bleeds and annualized rate of traumatic bleeds.

    6 months

  • +14 more secondary outcomes

Study Arms (1)

prophylactic treatment

EXPERIMENTAL

Subjects in PK Subgroup receive a single and multiple dose of 50 IU/kg FRSW107 at Visit 1 and Visit 5, respectively. PK samples will be collected up to 72 hours after the start of administration.After completion of PK blood sampling for the first dose and prior to availability of the corresponding PK data, subjects may continue prophylactic treatment with FRSW107 at a dose of 50 IU/kg every 3 days until their PK data are obtained.Once the first-dose PK data of a subject are available, individualized prophylactic treatment with FRSW107 will be implemented based on the PK results. On the premise of maintaining a trough FVIII activity level of ≥1%, the investigator will determine the appropriate individualized prophylactic regimen for the subject. The recommended prophylactic dosing interval is Q3D, with an optional dose range of 25-50 IU/kg. For subjects in the non-PK subgroup, the investigator will select the initial prophylactic dose within the recommended range of 25-50 IU/kg.

Drug: FRSW107

Interventions

FRSW107DRUG

For subjects in the PK subgroup: they will receive a dose of 50 IU/kg at the first dose visit 1 to obtain preliminary pharmacokinetic (PK) data. After assessment by the investigator, individualized prophylactic treatment (25\~50 IU/kg, Q3D) will be administered to maintain the trough concentration of FVIII activity at ≥1%. For subjects not in the PK subgroup: they will receive prophylactic treatment at a dose of 25\~50 IU/kg once every three days. If a subject experiences a breakthrough bleeding episode requiring treatment, the investigator shall determine the appropriate dosage (recommended dose range: 20\~50 IU/kg) and administration frequency.

prophylactic treatment

Eligibility Criteria

Age12 Years - 65 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ age ≤65 year-old men; 2.Subjects with clinically confirmed severe hemophilia A, i.e. at screening (central laboratory testing) or previous medical records confirm: FⅧ activity \< 1%; 3.Previous documented treatment with any recombinant and/or blood-derived coagulation factor Ⅷ products or cryoprecipitation products and dosed ≥150 exposure days (EDs≥150) ; 4.Normal prothrombin time (PT) or International Normalized Ratio (INR)\<1.3; 5.Bleeding events were recorded in detail for at least 6 months prior to screening; 6.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

You may not qualify if:

  • 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;
  • 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;
  • Subjects with abnormal renal function: Creatinine clearance (Ccr) \<50 ml/min (according to Cockcroft and Gault formula); or Serum creatinine (Cr) \>1.5x ULN;
  • Subjects 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);
  • Subjects 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;
  • Subjects who have received transfusions of blood or blood components within 4 weeks prior to screening;
  • Participants who had participated in other Interventional clinical trials within 1 month before screening;
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

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

Tianjin, Tianjin Municipality, China

RECRUITING

Fuyang Hospital, Affiliated to Anhui Medical University

Fuyang, China

NOT YET RECRUITING

Fujian Medical University Union Hospital

Fuzhou, China

NOT YET RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, China

NOT YET RECRUITING

Anhui Provincial Hospital

Hefei, China

NOT YET RECRUITING

Jinan central hospital

Jinan, China

NOT YET RECRUITING

The Second Affiliated Hospital of Kunming Medical University

Kunming, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

NOT YET RECRUITING

Affiliated Hospital of Nantong University

Nantong, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanyang Medical College

Nanyang, China

NOT YET RECRUITING

Qinghai Provincial People's Hospital

Qinghai, China

NOT YET RECRUITING

The Second Hospital of Shanxi Medical University

Taiyuan, China

NOT YET RECRUITING

North China University of Science and Technology Affiliated Hospital

Tangshan, China

NOT YET RECRUITING

Wenzhou People's Hospital

Wenzhou, China

NOT YET RECRUITING

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

Wuhan, China

NOT YET RECRUITING

Affiliated Hospital of Jiangnan University

Wuxi, China

NOT YET RECRUITING

Xi'an Central Hospital

Xi'an, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, China

NOT YET RECRUITING

Zhengzhou People's Hospital

Zhengzhou, China

NOT YET RECRUITING

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Renchi Yang, PhD

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

    STUDY CHAIR

Central Study Contacts

Lijia Liu

CONTACT

+ 86 18645377793lijialiu@gensciences.cn

Renchi Yang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2026

First Posted

July 6, 2026

Study Start

June 12, 2026

Primary Completion (Estimated)

March 9, 2027

Study Completion (Estimated)

June 21, 2027

Last Updated

July 6, 2026

Record last verified: 2026-06

Locations

CN(19)