MedTrace Logo

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

NCT06399289 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-01-08

No results posted yet for this study

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

BIOLOGICAL

Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)

Lyophilized powder for solution for intravenous injection

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Clinical Program Director · CSL Behring

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-28
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06399289 on ClinicalTrials.gov