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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemophilia A

Intervention / Treatment
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* Drug: New FVIII products


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient/caregiver of Kovaltry or Jivi<br>Patients who are switching factor replacement products to Kovaltry or Jivi and patients who have switched factor replacement products to Kovaltry or Jivi previously | Drug: New FVIII products<br>* Kovaltry or Jivi prescribed by the treating Physician<br>|
| Physician Group<br>Physicians participating in the study are associated with US hemophilia treatment centers that are affiliated with the ATHN hemophilia treatment center network | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Up to 4 years | 
| Patient reported root of expectations using a Bayer designed survey | Data from consenting patients will be collected by ATHN | 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 | Up to 4 years | 
| Physicians reported discipline using a Bayer designed survey | Data from consenting patients will be collected by ATHN | 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 | Up to 4 years | 
| Dosing Regimen (pre/post-switch) | Data from consenting patients will be collected by ATHN | 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 | 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 | 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 | 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 | Up to 4 years |