An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B

Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Swedish Orphan Biovitrum Research Site, Brno, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have a diagnosis of haemophilia B
Have started Alprolix treatment prior to enrolment visit, or at enrolment prescribed treatment with Alprolix irrespective of participation in the study
Signed and dated informed consent provided by the patient, or the patients legally acceptable representative for patients under the legal age, before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations.

Exclusion criteria

Participation in an investigational medicinal product trial at enrolment visit

Treatment and study plan

Alprolix

Drug

Extended half-life factor IX product

Other names: Eftrenonacog alfa, rFIXFc

Primary outcomes

Annualised bleeding rate (ABR)

Time frame: 24 months

Bleeding episodes assessed according to local practice
Annualised injection frequency

Time frame: 24 months

Assessed by prescription
Annualised factor consumption

Time frame: 24 months

Assessed by dispensed factor product

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Registry information

Official study title

A 24-month Prospective, Non-interventional, International, Multicentre Study to Describe the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B

Acronym: B-MORE

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Apr 3, 2019
Registry last updated: Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed