Haemophilia A, Haemophilia B
Conditions
Keywords
Blood Coagulation Disorder, Hematologic Diseases, Coagulation Protein Disorder, Hemorrhagic Disorder, Genetic Diseases, Inborn
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.
Interventions
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualised bleeding rate (ABR) | 24 months | Based on bleeding episodes assessed by local practice |
| Annualised injection frequency | 24 months | Assessed by prescription |
| Annualised factor consumption (IU) | 24 months | Assessed by dispensed factor product |
Countries
Germany
Outcome results
None listed