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)
Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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. 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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Beijing tongren hospital,CMU
RECRUITING
Beijing
XiangYa Hospital CentralSouth University
RECRUITING
Changsha
The Second Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital，Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
Jinan central hospital
RECRUITING
Jinan
The First Affiliated Hospital of Shandong First Medical University
RECRUITING
Jinan
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The First Hospital of Lanzhou University
RECRUITING
Lanzhou
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
Affiliated Hospital of Nantong University
RECRUITING
Nantong
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
NOT_YET_RECRUITING
Shanghai
Shenzhen Second People's Hospital
RECRUITING
Shenzhen
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The Second Hospital of Shanxi Medical University
RECRUITING
Taiyuan
North China University of Science and Technology Affiliated Hospital
RECRUITING
Tangshan
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
RECRUITING
Tianjin
Affiliated Hospital of Jiangnan University
RECRUITING
Wuxi
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Zhenyu Li
NOT_YET_RECRUITING
Xuzhou
Subei People's Hospital of Jiangsu province
RECRUITING
Yangzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Zhengzhou People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Chen Ling
chenling@gensciences.cn
+ 86 15896762713
Backup
Renchi Yang, PhD
Time Frame
Start Date:2023-12-27
Estimated Completion Date:2026-09-01
Participants
Target number of participants:120
Treatments
Experimental: Prevention and Treatment Group (PPX group)
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.
Experimental: On Demand/Preventive Treatment Group (On Demand /PPX Group)
The appropriate dose and frequency of administration of FRSW117 is recommended until bleeding events are controlled or returned to pre-bleeding activity.
Experimental: Perioperative management
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