Hemophilia B
Conditions
Keywords
Blood Coagulation Disorder, Hematologic Diseases, Coagulation Protein Disorder, Hemorrhagic Disorder, Genetic Diseases, Inborn
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.
Interventions
DRUGAlprolix
Extended half-life factor IX product
Sponsors
Swedish Orphan Biovitrum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualised bleeding rate (ABR) | 24 months | Bleeding episodes assessed according to local practice |
| Annualised injection frequency | 24 months | Assessed by prescription |
| Annualised factor consumption | 24 months | Assessed by dispensed factor product |
Countries
Czechia, Greece, Ireland, Italy, Norway, Saudi Arabia, Spain, Sweden, United Kingdom
Outcome results
None listed