Hemophilia A
Conditions
Brief 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 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.
Detailed description
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.
Interventions
DRUGNew FVIII products
Kovaltry or Jivi prescribed by the treating Physician
Sponsors
American Thrombosis and Hemostasis Network
Bayer
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Hemophilia A patients who have switched treatment to treatment with Kovaltry or Jivi within the past 50 weeks, who are enrolled the ATHN 2: Factor Switching Study, and who have consented to participate in the Kovaltry or Jivi specific module will be included in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey | Up to 4 years | Data from consenting patients will be collected by ATHN |
| Patient expectations of switching FVIII replacement therapy to Kovaltry or Jivi would affect lifestyle/quality of life using a Bayer designed survey | Up to 4 years | Data from consenting patients will be collected by ATHN |
| Patient expectations when adjusting to the new product after switch using a Bayer designed survey | Up to 4 years | Data from consenting patients will be collected by ATHN |
| Patient reported root of expectations using a Bayer designed survey | Up to 4 years | Data from consenting patients will be collected by ATHN |
| Patient reported reasons that would deter them from switching FVIII replacement products using a Bayer designed survey | Up to 4 years | Data from consenting patients will be collected by ATHN |
| Physicians reported discipline using a Bayer designed survey | Up to 4 years | Data from consenting patients will be collected by ATHN |
| Physicians reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey | Up to 4 years | Data from consenting patients will be collected by ATHN |
| Dosing Regimen (pre/post-switch) | Up to 4 years | Data from consenting patients will be collected by ATHN |
| Physicians reported reason of newly selected dose/dosing interval using a Bayer designed survey | Up to 4 years | Data from consenting patients will be collected by ATHN |
| Physicians reported rationale base for new dosing regimen selection using a Bayer designed survey | Up to 4 years | Data from consenting patients will be collected by ATHN |
| Physicians reported communication about adjustment period when switching using a Bayer designed survey | Up to 4 years | Data from consenting patients will be collected by ATHN |
| Physicians reported reasons that a provider would not encourage a patient to switch FVIII products using a Bayer designed survey | Up to 4 years | Data from consenting patients will be collected by ATHN |
Countries
United States
Outcome results
None listed