Factor Product Utilization and Health Outcomes in Patients With Hemophilia

University of British Columbia logo

University of British Columbia

Status

Completed

Conditions

Hemophilia B, Congenital
Hemophilia A, Congenital

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02796222
CAN-FAB-15-10911

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

Male

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males ≥12 years of age with severe and moderate congenital hemophilia A or B (baseline factor activity<5%)
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent or assent and authorization to use protected health information (PHI) in accordance with national and local privacy regulations.

Exclusion criteria

  • Unable or unwilling to provide informed consent
  • Patients with an existing bleeding disorder other than hemophilia A or B
  • History of hypersensitivity or severe allergic reactions to factor products
  • Patients currently participating in a phase 1-3 study with another factor replacement product
  • Unable to adhere to the study requirements based on the judgment of the Prescribing Physician (e.g. unable to enter accurate and timely infusion and bleeding records)

Trial design

61 participants in 4 patient groups

Hemophilia A patients on rFVIIIFc
Description:
Patients with hemophilia A who switch from on-demand or prophylactic treatment with rFVIII to rFVIIIFc
Hemophilia A patients on rFVIII
Description:
Patients with hemophilia A who remain on on-demand or prophylactic treatment with rFVIII
Hemophilia B patients on rFIXFc
Description:
Patients with hemophilia B who switch from on-demand or prophylactic treatment with rFIX to rFIXFc
Hemophilia A patients on rFIX
Description:
Patients with hemophilia B who remain on on-demand or prophylactic treatment with rFIX

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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