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

September 17, 2024 updated by: Swedish Orphan Biovitrum

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Swedish Orphan Biovitrum Research Site (CHU de Bordeaux)
      • Brest, France
        • Swedish Orphan Biovitrum Research site
      • Caen, France
        • Swedish Orphan Biovitrum Research site
      • Chambéry, France
        • Swedish Orphan Biovitrum Research site
      • Clermont-Ferrand, France
        • Swedish Orphan Biovitrum Research site
      • Dijon, France
        • Swedish Orphan Biovitrum Research site
      • La Réunion, France
        • Swedish Orphan Biovitrum Research site
      • Lille, France
        • Swedish Orphan Biovitrum Research site
      • Marseille, France
        • Swedish Orphan Biovitrum Research site
      • Montpellier, France
        • Swedish Orphan Biovitrum Research site
      • Nantes, France
        • Swedish Orphan Biovitrum Research site
      • Nîmes, France
        • Swedish Orphan Biovitrum Research site
      • Paris, France
        • Swedish Orphan Biovitrum Research site
      • Poitiers, France
        • Swedish Orphan Biovitrum Research site
      • Rennes, France
        • Swedish Orphan Biovitrum Research site
      • Rouen, France
        • Swedish Orphan Biovitrum Research site
      • Strasbourg, France
        • Swedish Orphan Biovitrum Research site
      • Toulouse, France
        • Swedish Orphan Biovitrum Research site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All eligible patients who present for a routine Clinical visit will be asked to participate in the study by the treating physician at participating haemophilia treatment centres in France.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prophylactic patients
Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment
Drug: Alprolix
Extended half-life factor IX product
Other Names:
  • Eftrenonacog alfa, rFIXFc
On demand patients
Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for on-demand treatment
Drug: Alprolix
Extended half-life factor IX product
Other Names:
  • Eftrenonacog alfa, rFIXFc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualised bleeding rate (ABR) (prophylactic treatment)
Time Frame: 24 months
Assessed by diary
24 months
Annualised injection frequency (prophylactic treatment)
Time Frame: 24 months
Assessed by diary
24 months
Annualised factor consumption (International Unit [IU]) (prophylactic treatment)
Time Frame: 24 months
Assessed by diary
24 months
Amount of factor Product used to treat a bleed (on-demand treatment)
Time Frame: 24 months
Assessed by diary
24 months
Number of injections to treat a bleed (on-demand treatment)
Time Frame: 24 months
Assessed by diary
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Orphan Biovitrum

Collaborators

Cerner Enviza

Investigators

  • Study Director: Elena Santagostino, MD, Swedish Orphan Biovitrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2018

Primary Completion (Actual)

March 16, 2022

Study Completion (Actual)

March 16, 2022

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sobi.Alprolix-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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