NCT02796222

Factor Product Utilization and Health Outcomes in Patients With Hemophilia

Factor Product Utilization and Health Outcomes in Patients With Hemophilia A and B in Canada: An Observational Study of Real-world Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 61 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Recombinant factor VIII Fc (rFVIIIFc) and recombinant factor IX Fc (rFIXFc) are extended half-life coagulation factors approved by Health Canada in 2014 for the treatment of severe hemophilia A and B, respectively. The objectives of this observational study is to describe the change in annual factor consumption, clinical and patient-reported outcomes for patients who switch from recombinant factor VIII (rFVIII) and recombinant factor IX (rFIX) to rFVIIIFc/ rFIXFc in Canada, and to explore clinicians' and patients' reasons for switching or not switching.

Conditions

• Hemophilia A, Congenital
• Hemophilia B, Congenital

Timeline

• Start date: 2016-04-01
• Primary completion: 2021-04-26
• Completion: 2021-04-26
• First posted: 2016-06-10
• Last updated: 2021-04-28

Locations

1 site across 1 country: Canada