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A Longitudinal, Observational Study of Previously Treated Hemophilia Patients Switching Factor Replacement Products


Supportive Care | Non Therapeutic

What is the purpose of this trial?

This is a longitudinal, observational study of patients with Hemophilia A or B who are planning to switch to a newly approved coagulation factor replacement product, or who have recently switched factor products. The study will follow each patient for up to 1 year. Patients will be recruited at Hemophilia Treatment Centers (HTC) which are ATHN-affiliates. The primary outcome being studied is the development of inhibitor (i.e., antibodies to factor) at 1 year or 50 exposure days, whichever comes first.

The study will be conducted at approximately 30 HTCs, with a planned enrollment of 600 patients.The entire study duration is projected to be approximately 6 years.

In addition, optional substudies will be included for some products, as "Product-Specific Modules". These will be questionnaires to collect data for subjects receiving selected Factor products. For example, subjects receiving Eloctate will be approached to participate in the 'Eloctate Product-Specific Module'; subjects receiving Adynovate will be approached to participate in the 'Adynovate Product-Specific Module'. Questions will be related to product use, perceptions of product use, and other post-marketing consumer data.

  • Trial with
    American Thrombosis and Hemostasis Network (ATHN)
  • Start Date
  • End Date
Trial Image

For more information about this study, contact:

Sharon Huie

I'm interested in volunteering

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email or call 877.978.8343

  • Last Updated
  • Study HIC