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 or Jivi. 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.
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 from another product to Kovaltry or Jivi 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.
Study Type
OBSERVATIONAL
Enrollment
3
Kovaltry or Jivi prescribed by the treating Physician
University of California, San Diego
La Jolla, California, United States
University of Colorado Denver Hemophilia and Thrombosis Center
Aurora, Colorado, United States
Yale Hemophilia Treatment Center
New Haven, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Patient reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
Patient expectations of switching FVIII replacement therapy to Kovaltry or Jivi would affect lifestyle/quality of life using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
Patient expectations when adjusting to the new product after switch using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
Patient reported root of expectations using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
Patient reported reasons that would deter them from switching FVIII replacement products using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
Physicians reported discipline using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
Physicians reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
Dosing Regimen (pre/post-switch)
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
Physicians reported reason of newly selected dose/dosing interval using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
Physicians reported rationale base for new dosing regimen selection using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
Physicians reported communication about adjustment period when switching using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
Physicians reported reasons that a provider would not encourage a patient to switch FVIII products using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Time frame: Up to 4 years
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St. Josephs Hemophilia Treatment Center
Tampa, Florida, United States
Emory / Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States
Indiana Hemophilia and Thrombosis Center IHTC
Indianapolis, Indiana, United States
Louisiana Center for Bleeding and Clotting Disorders / Tulane
New Orleans, Louisiana, United States
...and 17 more locations