Hemophilia B

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

NCT06399289 | PHASE 3 | INTERVENTIONAL

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.

6 Sites

23 Participants

Recruiting

18 Years to 70 Years

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SUBMIT

Beijing Children's Hospital

Beijing,Beijing,China,100045

Union Hospital Affiliated to Fujian Medical University

Fuzhou,Fujian,China,350001

Nanfang Hospital of Southern Medical University

Guangzhou,Guangdong,China,510515

Affiliated Hospital of Guizhou Medical University

Guiyang,Guizhou,China,550004

Jinan Central Hospital

Jinan,Shandong,China,250013

Hospital of Hematology, Chinese Academy of Medical Sciences

Tianjin,Tianjin,China,300020

Study 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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov