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

NCT ID: NCT06399289

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-28
• Study Completion Date: 2026-12-01

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.

Conditions

Hemophilia B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

rIX-FP

Subjects will receive rIX-FP as an intravenous (IV) infusion for a minimum of 50 exposure days (EDs)

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Lyophilized powder for solution for intravenous injection

Interventions

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

Lyophilized powder for solution for intravenous injection

Intervention Type: BIOLOGICAL

Other Intervention Names

rIX-FP; CSL654; Idelvion

Eligibility Criteria

Inclusion Criteria

• - Male Chinese subjects aged ≤ 70 years
• - Subjects with documented severe or moderately severe hemophilia B (FIX activity of ≤ 2%)
• - Subjects have received FIX products for ≥ 150 exposure days (EDs) (subjects aged ≥ 6 years) or ≥ 50 EDs (subjects aged < 6 years)
• - Subjects have no confirmed prior history of FIX inhibitor formation

Exclusion Criteria

• - Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein.
• - Known congenital or acquired coagulation disorder other than congenital FIX deficiency.
• - Currently receiving intravenous (IV) immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
• - Currently receiving a long-acting recombinant FIX treatment such as coagulation factor IX (recombinant), Fc fusion protein (Alprolix®).
• - Use of traditional or herbal Chinese medicine(s) with an impact on hemophilia, including coagulation, within 28 days before Day 1 and / or refusal to abstain from these during the study until the end of the subject's participation in the study.

• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Program Director

Role: STUDY_DIRECTOR

CSL Behring

Locations

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

Countries

China

Other Identifiers

2022-002333-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSL654_3004

Identifier Type: -

Identifier Source: org_study_id