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Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy
Sponsor: CSL Behring
Summary
This study will investigate the pharmacokinetics (PK), efficacy, and safety of rIX-FP for the routine prophylaxis of bleeding episodes in male Chinese previously treated patients (PTPs) with hemophilia B (FIX activity of ≤ 2%). In addition to the scheduled rIX-FP prophylaxis regimen, subjects may also receive rIX-FP episodic (on-demand) treatment for breakthrough bleeding episodes and rIX-FP for the prophylaxis and treatment of bleeding in emergency surgical procedures.
Official title: A Phase 3, Open-label, Multicenter, Pharmacokinetics, Efficacy, and Safety Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Chinese Subjects With Hemophilia B
Key Details
Gender
MALE
Age Range
Any - 70 Years
Study Type
INTERVENTIONAL
Enrollment
23
Start Date
2024-07-28
Completion Date
2026-12-01
Last Updated
2026-01-08
Healthy Volunteers
No
Conditions
Interventions
Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)
Lyophilized powder for solution for intravenous injection
Locations (7)
Beijing Children's Hospital
Beijing, Beijing Municipality, China
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
North China University Of Science And Technology Affiliated Hospital
Tangshan, Hebei, China
Jinan Central Hospital
Jinan, Shandong, China
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China