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

NCT07663903 | Recruiting Phase 3

• 1 other identifier: SS-107-III05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 24

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (7)

• Number of infusions and IU/kg of FRSW107 needed for the treatment of bleeding episodes

  6 months

• FVIII activity during on-demand: activity recovery rate

  Visit1,Day1

• Hemophilia Joint Health Score (HJHS 2.1) during on-demand treatment

  6 month

• incidence of lack of drug efficacy

  6 months

• Occurrence of AEs and SAEs

  6 month

Study Arms (1)

On-demand Treatment.

EXPERIMENTAL

On-demand treatment (recommended range: 20-50 IU/kg)

Drug: FRSW107

Interventions

FRSW107 DRUG

Treatment for 6 months as needed.

On-demand Treatment.

Eligibility Criteria

• Age: 12 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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;
• 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;

Sponsors & Collaborators

• Hangzhou Gensciences Biopharmaceutical Co., Ltd.: lead

Study Sites (24)

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

Ganzhou People's Hospital

Ganzhou, China

NOT YET RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, China

NOT YET RECRUITING

Anhui Provincial Hospital

Hefei, China

NOT YET RECRUITING

Huai'an Second People's Hospital

Huai'an, 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

Rizhao People's Hospital

Rizhao, China

NOT YET RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, 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

Subei People's Hospital of Jiangsu province

Yangzhou, 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, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, 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 1645377793; lijialiu@gensciences.cn

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 15, 2026
• First Posted: June 23, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

CN (24)