NCT06399289

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

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Registry fields

Overall status: COMPLETED
Conditions: Hemophilia B
Study type: INTERVENTIONAL
Phase: PHASE3
Primary purpose: PREVENTION
Intervention type: BIOLOGICAL
Interventions: Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)
Lead sponsor: CSL Behring (INDUSTRY)

Cached at: 2026-07-24 09:04:05

View on ClinicalTrials.gov

Brief 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.

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