RecruitingPhase 3NCT06142552

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

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)

Sponsor

Jiangsu Gensciences lnc.

Enrollment

120 participants

Start Date

Dec 27, 2023

Study Type

INTERVENTIONAL

Conditions

Severe Hemophilia A

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

Sex: MALEMin Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is evaluating the safety and effectiveness of FRSW117 — a long-acting recombinant Factor VIII-Fc fusion protein — as a prophylactic (preventive) treatment to reduce bleeding episodes in patients with severe hemophilia A, a genetic condition where the blood cannot clot properly due to a missing clotting factor. The study will also examine how well the drug works to control bleeding during surgical procedures and assess its pharmacokinetics (how the body processes the drug) and immunogenicity (whether the immune system develops antibodies against it). Male patients aged 12 to 65 with confirmed severe hemophilia A (Factor VIII activity below 1%), at least 150 prior treatment days with clotting factor products, and at least 6 bleeding episodes in the past 6 months are eligible, while those with inhibitors to Factor VIII, severe anemia, active hepatitis, HIV, or serious heart or kidney conditions are excluded. Participants will receive regular subcutaneous injections of FRSW117 and attend clinical visits for blood draws, safety assessments, and bleeding documentation. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFRSW117

once a week, 50 weeks and as needed

Locations(28)

Beijing tongren hospital,CMU

Beijing, China

XiangYa Hospital CentralSouth University

Changsha, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Fujian Medical University Union Hospital

Fuzhou, China

Nanfang Hospital of Southern Medical University

Guangzhou, China

The First Affiliated Hospital，Zhejiang University School of Medicine

Hangzhou, China

Anhui Provincial Hospital

Hefei, China

Jinan central hospital

Jinan, China

The First Affiliated Hospital of Shandong First Medical University

Jinan, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, China

The First Hospital of Lanzhou University

Lanzhou, China

Jiangxi Provincial People's Hospital

Nanchang, China

Nanjing Drum Tower Hospital

Nanjing, China

Affiliated Hospital of Nantong University

Nantong, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

Shanghai, China

Shenzhen Second People's Hospital

Shenzhen, China

The First Affiliated Hospital of Soochow University

Suzhou, China

The Second Hospital of Shanxi Medical University

Taiyuan, China

North China University of Science and Technology Affiliated Hospital

Tangshan, China

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

Tianjin, China

Affiliated Hospital of Jiangnan University

Wuxi, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

Zhenyu Li

Xuzhou, China

Subei People's Hospital of Jiangsu province

Yangzhou, China

Henan Cancer Hospital

Zhengzhou, China

Henan Provincial People's Hospital

Zhengzhou, China

Zhengzhou People's Hospital

Zhengzhou, China

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