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
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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%).
Eligibility
Participation Requirements
Sex: Male
Maximum Age: 65
Healthy Volunteers: f
View:
• • Male Chinese participants \<= 65 years of age.
• • Participants with severe hemophilia A (FVIII activity \< 1%).
• • Participants who have received FVIII products for \>= 150 EDs (\>= 6 years of age) or \>= 50 EDs (\< 6 years of age).
Locations
Other Locations
China
Beijing Children's Hospital
RECRUITING
Beijing
Hunan Provincial Children's Hospital
RECRUITING
Changsha
Children's Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Guangzhou Women and Children's Medical Center
RECRUITING
Guangzhou
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
The Children's Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Second Hospital of Anhui Medical University
RECRUITING
Hefei
Henan children's hospital Zhengzhou children's Hospital
NOT_YET_RECRUITING
Henan
Nanjing Children's Hospital
RECRUITING
Jiangsu
Jinan Central Hospital
RECRUITING
Jinan
The second affiliated hospital of Kunming Medical University
RECRUITING
Kunming
Liuzhou People's Hospital
RECRUITING
Liuchow
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
Qingdao Women and Children's Hospital
RECRUITING
Qingdao
Ruijin Hospital, hanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
North China University of Science and Technology Affiliated Hospital
RECRUITING
Tangshan
Hospital of Hematology, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Quinghai Provincial People's Hospital
RECRUITING
Xining
XuZhou Children's Hospital
RECRUITING
Xuzhou
Contact Information
Primary
Trial Registration Coordinator
clinicaltrials@cslbehring.com
+1-610-878-4000
Time Frame
Start Date: 2025-01-09
Estimated Completion Date: 2026-06-26
Participants
Target number of participants: 60
Treatments
Experimental: rVIII-SingleChain
Participants will receive rVIII-SingleChain as an intravenous (IV) infusion for a minimum of 50 exposure days (EDs).
Related Therapeutic Areas
Sponsors
Leads: CSL Behring