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

Sponsor
Swedish Orphan Biovitrum (Industry)
Overall Status
Completed
CT.gov ID
NCT03655340
Collaborator
Kantar Health (Industry)
91
Enrollment
18
Locations
42.1
Actual Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
91 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
Sep 12, 2018
Actual Primary Completion Date :
Mar 16, 2022
Actual Study Completion Date :
Mar 16, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Annualised bleeding rate (ABR) (prophylactic treatment) [24 months]

      Assessed by diary

    2. Annualised injection frequency (prophylactic treatment) [24 months]

      Assessed by diary

    3. Annualised factor consumption (International Unit [IU]) (prophylactic treatment) [24 months]

      Assessed by diary

    4. Amount of factor Product used to treat a bleed (on-demand treatment) [24 months]

      Assessed by diary

    5. Number of injections to treat a bleed (on-demand treatment) [24 months]

      Assessed by diary

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Swedish Orphan Biovitrum Research Site (CHU de Bordeaux) Bordeaux France
    2 Swedish Orphan Biovitrum Research Site Brest France
    3 Swedish Orphan Biovitrum Research Site Caen France
    4 Swedish Orphan Biovitrum Research Site Chambéry France
    5 Swedish Orphan Biovitrum Research Site Clermont-Ferrand France
    6 Swedish Orphan Biovitrum Research Site Dijon France
    7 Swedish Orphan Biovitrum Research Site La Réunion France
    8 Swedish Orphan Biovitrum Research Site Lille France
    9 Swedish Orphan Biovitrum Research Site Marseille France
    10 Swedish Orphan Biovitrum Research Site Montpellier France
    11 Swedish Orphan Biovitrum Research Site Nantes France
    12 Swedish Orphan Biovitrum Research Site Nîmes France
    13 Swedish Orphan Biovitrum research site Paris France
    14 Swedish Orphan Biovitrum research site Poitiers France
    15 Swedish Orphan Biovitrum research site Rennes France
    16 Swedish Orphan Biovitrum Research Site Rouen France
    17 Swedish Orphan Biovitrum research site Strasbourg France
    18 Swedish Orphan Biovitrum Research Site Toulouse France

    Sponsors and Collaborators

    • Swedish Orphan Biovitrum
    • Kantar Health

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Swedish Orphan Biovitrum
    ClinicalTrials.gov Identifier:
    NCT03655340
    Other Study ID Numbers:
    • Sobi.Alprolix-001
    First Posted:
    Aug 31, 2018
    Last Update Posted:
    May 12, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Swedish Orphan Biovitrum
    Blood Coagulation Disorder
    Hematologic Diseases
    Coagulation Protein Disorder
    Hemorrhagic Disorder
    Genetic Diseases, Inborn
    Additional relevant MeSH terms:
    Hemophilia A
    Hemophilia B

    Study Results

    No Results Posted as of May 12, 2022