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

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.

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Key information

Conditions

Haemophilia 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 Hemophilia B Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Swedish Orphan Biovitrum Research Site (CHU de Bordeaux), Bordeaux, France

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 and been treated previously with factor IX Product
Have started Alprolix treatment prior to enrolment visit, or at enrolment prescribed treatment with Alprolix, regardless of participation in the study
Signed and dated informed consent provided by the patient, or the patient's 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) (prophylactic treatment)

Time frame: 24 months

Assessed by diary
Annualised injection frequency (prophylactic treatment)

Time frame: 24 months

Assessed by diary
Annualised factor consumption (International Unit [IU]) (prophylactic treatment)

Time frame: 24 months

Assessed by diary
Amount of factor Product used to treat a bleed (on-demand treatment)

Time frame: 24 months

Assessed by diary
Number of injections to treat a bleed (on-demand treatment)

Time frame: 24 months

Assessed by diary

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Registry information

Official study title

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

Acronym: B-SURE

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Aug 31, 2018
Registry last updated: Sep 19, 2024

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