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PREVENT: A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B

Sponsor
Swedish Orphan Biovitrum (Industry)
Overall Status
Completed
CT.gov ID
NCT03055611
Collaborator
(none)
201
Enrollment
22
Locations
59.3
Actual Duration (Months)
9.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and B.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
201 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-World Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
Actual Study Start Date :
May 9, 2017
Actual Primary Completion Date :
Apr 19, 2022
Actual Study Completion Date :
Apr 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Haemophilia A patients

Elocta will be prescribed according to local practice and administered by patients with haemophilia A for prophylactic treatment

Drug: ELOCTA
Extended half-life factor VIII product
Other Names:
  • Eloctate, efmoroctocog alfa, rFVIIIFc

    		•
    Haemophilia B 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

    		•

    Outcome Measures

    Primary Outcome Measures

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

      Based on bleeding episodes assessed by local practice

    2. Annualised injection frequency [24 months]

      Assessed by prescription

    3. Annualised factor consumption (IU) [24 months]

      Assessed by dispensed factor product

    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 A or B and previously treated with factor Product

    • Have started prophylactic Elocta/Alprolix treatment prior to enrollment visit, or at enrollment prescribed prophylactic treatment with Elocta or 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, from four weeks prior to first injection with Elocta or Alprolix to enrollment visit.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Swedish Orphan Biovitrum Reserach site Berlin Germany
    2 Swedish Orphan Biovitrum Reserach Site Blaubeuren Germany
    3 Swedish Orphan Biovitrum Research Site Bonn Germany
    4 Swedish Orphan Biovitrum Research Site Delmenhorst Germany
    5 Swedish Orphan Biovitrum Research Site Duisburg Germany
    6 Swedish Orphan Biovitrum Reserach site Erlangen Germany
    7 Swedish Orphan Biovitrum Research Site Frankfurt Germany
    8 Swedish Orphan Biovitrum Reserach site Frankfurt Germany
    9 Swedish Orphan Biovitrum Research Site Fürth Germany
    10 Swedish Orphan Biovitrum Research Site Hamburg Germany
    11 Swedish Orphan Biovitrum Research Site Hannover Germany
    12 Swedish Orphan Biovitrum Reserach site Hannover Germany
    13 Swedish Orphan Biovitrum Reserach site Heidelberg Germany
    14 Swedish Orphan Biovitrum Reserach site Homburg Germany
    15 Swedish Orphan Biovitrum Research Site Jena Germany
    16 Swedish Orphan Biovitrum Reserach Site Jena Germany
    17 Swedish Orphan Biovitrum Reserach site Leipzig Germany
    18 Swedish Orphan Biovitrum Reserach Site Mörfelden-Walldorf Germany
    19 Swedish Orphan Biovitrum Research Site München Germany
    20 Swedish Orphan Biovitrum Reserach site München Germany
    21 Swedish Orphan Biovitrum Reserach site Münster Germany
    22 Swedish Orphan Biovitrum Research Site Würzburg Germany

    Sponsors and Collaborators

    • Swedish Orphan Biovitrum

    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:
    NCT03055611
    Other Study ID Numbers:
    • Sobi.HAEM89-002
    First Posted:
    Feb 16, 2017
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2022
    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 4, 2022