A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia B

Phase 1

• Conditions: Hemophilia B; MedDRA version: 16.1Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 100000004850; Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

• Registration Number: EUCTR2011-002415-28-BG
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-29
• Last Update Posted: 28 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Male subjects, 12 to 65 years old.
• Severe hemophilia B (FIX activity of = 2%).
• Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for > 150 exposure days (EDs).
• No history of FIX inhibitor formation, no detectable inhibitors at Screening and no family history of inhibitors against FIX.
• Written informed consent for study participation.
• On-demand subjects only, who have experienced a minimum average of 2 non-trauma induced bleeding episodes requiring treatment with a FIX product during the previous 6 or 3 months.

Are the trial subjects under 18? yes
Number of subjects for this age range: 3
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

• Known hypersensitivity to any FIX product or hamster protein.
• Known congenital or acquired coagulation disorder other than congenital FIX deficiency.
• HIV positive subjects with a CD4 count < 200/mm3.
• Low platelet count, kidney or liver dysfunction.
• Recent life-threatening bleeding episode.

Study & Design

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