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

CSL Behring

Status and phase: Active, not recruiting; Phase 3

Conditions: Hemophilia B

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06399289

CSL654_3004

2022-002333-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 23 estimated patients

Sex: Male

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

rIX-FP

Experimental group

Description:

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

Treatment:

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