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

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研究单位: [1]Jiangsu Gensciences lnc. [2]Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College. [3]Beijing tongren hospital,CMU,Beijing,China [4]XiangYa Hospital CentralSouth University,Changsha,China [5]The Second Affiliated Hospital of Chongqing Medical University,Chongqing,China [6]Fujian Medical University Union Hospital,Fuzhou,China [7]Nanfang Hospital of Southern Medical University,Guangzhou,China [8]The First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou,China [9]Anhui Provincial Hospital,Hefei,China [10]Jinan central hospital,Jinan,China [11]The First Affiliated Hospital of Shandong First Medical University,Jinan,China [12]The Second Affiliated Hospital of Kunming Medical University,Kunming,China [13]The First Hospital of Lanzhou University,Lanzhou,China [14]Jiangxi Provincial People's Hospital,Nanchang,China [15]Nanjing Drum Tower Hospital,Nanjing,China [16]Affiliated Hospital of Nantong University,Nantong,China [17]The Affiliated Hospital of Qingdao University,Qingdao,China [18]Ruijin Hospital, Shanghai Jiaotong University School Of Medicine,Shanghai,China [19]Shenzhen Second People's Hospital,Shenzhen,China [20]The First Affiliated Hospital of Soochow University,Suzhou,China [21]The Second Hospital of Shanxi Medical University,Taiyuan,China [22]North China University of Science and Technology Affiliated Hospital,Tangshan,China [23]Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College,Tianjin,China [24]Affiliated Hospital of Jiangnan University,Wuxi,China [25]The First Affiliated Hospital of Xiamen University,Xiamen,China [26]Zhenyu Li,Xuzhou,China [27]Subei People's Hospital of Jiangsu province,Yangzhou,China [28]Henan Cancer Hospital,Zhengzhou,China [29]Henan Provincial People's Hospital,Zhengzhou,China [30]Zhengzhou People's Hospital,Zhengzhou,China

关键词: Pharmacokinetics Safety immunogenicity effectiveness

研究目的:
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.

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