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

Swedish Orphan Biovitrum151 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

151

Conditions

Hemophilia B

Interventions

AlprolixDRUG

Extended half-life factor IX product

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 patients 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

Locations (29)

Outcomes

Primary Outcomes

Annualised bleeding rate (ABR)

Bleeding episodes assessed according to local practice

Time frame: 24 months

Annualised injection frequency

Assessed by prescription

Time frame: 24 months

Annualised factor consumption

Assessed by dispensed factor product

Time frame: 24 months

Data from ClinicalTrials.gov

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