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

January 31, 2024 updated by: Swedish Orphan Biovitrum

A 24-month Prospective, Non-interventional, International, Multicentre Study to Describe 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

151

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

  • Czechia
      • Brno, Czechia
        • Swedish Orphan Biovitrum Research Site
      • Prague, Czechia
        • Swedish Orphan Biovitrum Research Site
  • Greece
      • Athens, Greece
        • Swedish Orphan Biovitrum Research Site (Haemophilia Center Aghia Sophia Children's Hospital)
      • Athens, Greece
        • Swedish Orphan Biovitrum Research Site (Laikο General Hospital of Athens)
  • Ireland
      • Dublin, Ireland
        • Swedish Orphan Biovitrum Research Site
  • Italy
      • Bari, Italy
        • Swedish Orphan Biovitrum Research Site
      • Florence, Italy
        • Swedish Orphan Biovitrum Research Site
      • Genova, Italy
        • Swedish Orphan Biovitrum Research Site
      • Milan, Italy
        • Swedish Orphan Biovitrum Research Site
      • Roma, Italy
        • Swedish Orphan Biovitrum Research Site
      • Turin, Italy
        • Swedish Orphan Biovitrum Research Site
  • Norway
      • Oslo, Norway
        • Swedish Orphan Biovitrum Research Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Swedish Orphan Biovitrum Research Site (King Faisal Hospital adult)
      • Riyadh, Saudi Arabia
        • Swedish Orphan Biovitrum Research Site (King Faisal Hospital pediatric)
  • Spain
      • Barcelona, Spain
        • Swedish Orphan Biovitrum Research Site (Hospital de Vall d'Hebrón)
      • Barcelona, Spain
        • Swedish Orphan Biovitrum Research Site (Hospital Sant Joan de Deu)
      • Murcia, Spain
        • Swedish Orphan Biovitrum Research Site
      • Vigo, Spain
        • Swedish Orphan Biovitrum Research Site
  • Sweden
      • Gothenburg, Sweden
        • Swedish Orphan Biovitrum Research Site
      • Malmö, Sweden
        • Swedish Orphan Biovitrum Research Site
      • Stockholm, Sweden
        • Swedish Orphan Biovitrum Research Site (Karolinska University Hospital adult)
      • Stockholm, Sweden
        • Swedish Orphan Biovitrum Research Site (Karolinska University Hospital pediatric)
  • United Kingdom
      • Hull, United Kingdom
        • Swedish Orphan Biovitrum Research Site
      • London, United Kingdom, NW3 2QG
        • Swedish Orphan Biovitrum Research Site
      • London, United Kingdom, SE1 7EH
        • Swedish Orphan Biovitrum Research Site
      • London, United Kingdom, W12 0HS
        • Swedish Orphan Biovitrum Research Site
      • London, United Kingdom, WC1N 3JH
        • Swedish Orphan Biovitrum Research Site
      • Manchester, United Kingdom
        • Swedish Orphan Biovitrum Research Site
      • Oxford, United Kingdom
        • 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.

Description

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 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)
Time Frame: 24 months
Bleeding episodes assessed according to local practice
24 months
Annualised injection frequency
Time Frame: 24 months
Assessed by prescription
24 months
Annualised factor consumption
Time Frame: 24 months
Assessed by dispensed factor product
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, 2019

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (Actual)

April 3, 2019

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sobi.Alprolix-002

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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