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

Last updated: May 9, 2025
Sponsor: CSL Behring
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hemophilia

Treatment

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

Clinical Study ID

NCT06399289
CSL654_3004
2022-002333-34
  • Ages < 70
  • Male

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.

Eligibility Criteria

Inclusion

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 ≥ 6years) or ≥ 50 EDs (subjects aged < 6 years)

  • Subjects have no confirmed prior history of FIX inhibitor formation

Exclusion

Exclusion Criteria:

  • Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product orhamster protein.

  • Known congenital or acquired coagulation disorder other than congenital FIXdeficiency.

  • Currently receiving intravenous (IV) immunomodulating agents such as immunoglobulinor chronic systemic corticosteroid treatment.

  • Currently receiving a long-acting recombinant FIX treatment such as coagulationfactor 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 fromthese during the study until the end of the subject's participation in the study.

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)
Phase: 3
Study Start date:
June 28, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Beijing Children's Hospital

    Beijing, Beijing 100045
    China

    Site Not Available

  • Union Hospital Affiliated to Fujian Medical University

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou 550004
    China

    Site Not Available

  • North China University Of Science And Technology Affiliated Hospital

    Tangshan, Hebei 63000
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Hospital of Hematology, Chinese Academy of Medical Sciences

    Tianjin, Tianjin 300020
    China

    Site Not Available

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