Summary

for people ages 2 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

This US study aims to assess hemophilia A patient characteristics and reasons for switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A patients who have switched from an existing therapy to Kovaltry. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective.

Official Title

Assessing Hemophilia A Patient and Physician Reasons and Expectations for Switching Treatment to Kovaltry: A Nested Study Within an Existing Registry

Details

This observational study consists of a patient and a physician survey. This survey will consist of questions developed by Bayer and submitted to the Steering Committee of the existing registry, ATHN-2. Once enrolled to participate in the ATHN-2 registry and provided consent to participate in the Bayer nested study, patients who have switched for another product to Kovaltry within the past 50 weeks or at the time of enrollment will be prompted to answer the additional survey questions.

Conclusion of the ATHN-2 registry is scheduled for 2021. Once data is cleaned and locked by the registry, the data will be delivered to Bayer for conduct of our analyses.

Keywords

Hemophilia A Factor VIII Antihemophilic Factor (Kovaltry, BAY81-8973)

Eligibility

For people ages 2 years and up

Hemophilia A patients who have switched treatment to treatment with KOVALTRY within the past 50 weeks, who are enrolled the ATHN 2: Factor Switching Study, and who have consented to participate in the KOVALTRY specific module will be included in this study.

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States
  • University of Colorado Denver Hemophilia and Thrombosis Center accepting new patients
    Aurora Colorado 80045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bayer
ID
NCT03603275
Study Type
Observational
Last Updated
September 21, 2018