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

  • End date
    Jun 16, 2024
  • participants needed
  • sponsor
    Swedish Orphan Biovitrum
Updated on 16 September 2021
coagulation factor


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 Factor IX Deficiency, christmas disease
Treatment ALPROLIX
Clinical Study IdentifierNCT03901755
SponsorSwedish Orphan Biovitrum
Last Modified on16 September 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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