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Factor Product Utilization and Health Outcomes in Patients With Hemophilia

NCT02796222 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2021-04-28

No results posted yet for this study

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

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Shannon Jackson, MD · Division of Hematology, Department of Medicine, University of British Columbia

  • Robert Klaassen, MD · Division of Hematology/Oncology, Department of Pediatrics, University of Ottawa

  • Man-Chiu Poon, MD · Division of Hematology, Department of Medicine, University of Calgary

  • Sue Robinson, MD · Division of Hematology, Department of Medicine, Dalhousie University

  • John Wu, MD · BC Children's hospital, Division of Hematology, Department of Medicine, University of British Columbia

  • Alfonso Iorio, MD · Hemophilia Program, Hamilton Health Services Program, McMaster University

  • Michelle Sholzberg, MD · Hemophilia Program, St. Michael's Hospital, University of Toronto

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-04-26
Completion
2021-04-26

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796222 on ClinicalTrials.gov