Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in Chinese subjects with hemophilia B previously treated with FIX therapy

Phase 1

• Conditions: Hemophilia B; MedDRA version: 20.0Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2022-002333-34-Outside-EU/EEA
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: A
• Sex: Male
• Target Recruitment: Not specified

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified