Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy

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.

NCT Number	NCT06399289
Lead Sponsor	CSL Behring
Conditions	Hemophilia B
Enrollment	23 participants
Start Date	2024-07-28
Primary Completion	2026-07-07 (estimated)
Study Completion	2026-07-07 (estimated)
Updated on ClinicalTrials.gov	2026-07-23