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Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products
Sponsor: CSL Behring
Summary
For bridging the available global clinical data of rVIII-SingleChain, with the Chinese population, the aim of this study in China is to investigate the pharmacokinetics (PK) of rVIII-SingleChain after an initial and repeat dose and to assess efficacy and safety during 2 to 3 times weekly prophylaxis treatment with rVIII-SingleChain in male Chinese PTPs with severe hemophilia A (FVIII activity less than \[\<\] 1%).
Official title: A Phase 3, Open-label, Multicenter, Pharmacokinetics, Efficacy, and Safety Study of a Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Previously Treated Patients (PTPs) With Hemophilia A
Key Details
Gender
MALE
Age Range
0 Days - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-01-09
Completion Date
2026-06-26
Last Updated
2026-01-08
Healthy Volunteers
No
Conditions
Interventions
Recombinant single-chain factor VIII (rVIII-SingleChain)
Lyophilized powder for solution for intravenous injection
Locations (20)
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Children's Hospital
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Hebei, China
Henan children's hospital Zhengzhou children's Hospital
Zhengzhou, Henan, China
Hunan Provincial Children's Hospital
Changsha, Hunan, China
Nanjing Children's Hospital
Nanjing, Jiangsu, China
XuZhou Children's Hospital
Xuzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Quinghai Provincial People's Hospital
Xining, Qinghai, China
Jinan Central Hospital
Jinan, Shandong, China
Qingdao Women and Children's Hospital
Qingdao, Shandong, China
Shanghai Jiaotong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, China
The second affiliated hospital of Kunming Medical University
Kunming, Yunan, China
The Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China