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Study identifier: NCT06142552 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Severe Hemophilia A  ·  Sponsor: Hangzhou Gensciences Biopharmaceutical Co., Ltd.

PhasePhase 3
Planned participants120
Who can joinMale, 12 Years to 65 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Chen Ling  ·  + 86 15896762713  ·  chenling@gensciences.cn

Renchi Yang, PhD

Always discuss trial participation with your own doctor first.

Locations (28)

Beijing tongren hospital,CMUBeijing, ChinaRecruiting
XiangYa Hospital CentralSouth UniversityChangsha, ChinaRecruiting
The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaNot Yet Recruiting
Fujian Medical University Union HospitalFuzhou, ChinaRecruiting
Nanfang Hospital of Southern Medical UniversityGuangzhou, ChinaRecruiting
The First Affiliated Hospital,Zhejiang University School of MedicineHangzhou, ChinaNot Yet Recruiting
Anhui Provincial HospitalHefei, ChinaRecruiting
Jinan central hospitalJinan, ChinaRecruiting
The First Affiliated Hospital of Shandong First Medical UniversityJinan, ChinaRecruiting
The Second Affiliated Hospital of Kunming Medical UniversityKunming, ChinaRecruiting
The First Hospital of Lanzhou UniversityLanzhou, ChinaRecruiting
Jiangxi Provincial People's HospitalNanchang, ChinaRecruiting

+ 16 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06142552