Assessing Hemophilia A Patient and Physician Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 3
- 试验地点
- 27
- 主要终点
- Physicians reported discipline using a Bayer designed survey
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patient/caregiver of Kovaltry or Jivi
Patients who are switching factor replacement products to Kovaltry or Jivi and patients who have switched factor replacement products to Kovaltry or Jivi previously
干预措施: New FVIII products (Drug)
结局指标
主要结局
Physicians reported discipline using a Bayer designed survey
时间窗: Up to 4 years
Data from consenting patients will be collected by ATHN
Dosing Regimen (pre/post-switch)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Up to 4 years
Data from consenting patients will be collected by ATHN
Patient reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey
时间窗: 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
时间窗: 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
时间窗: Up to 4 years
Data from consenting patients will be collected by ATHN
Patient reported root of expectations using a Bayer designed survey
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Up to 4 years
Data from consenting patients will be collected by ATHN
次要结局
未报告次要终点