NCT06399289

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: CSL Behring · Industry
• Sex: Male
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia B

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)	Lyophilized powder for solution for intravenous injection

Timeline

• Start date: 2024-07-28
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-05-03
• Last updated: 2026-01-08

Locations

7 sites across 1 country: China