Assessing Experiences with Haemophilia A and B: Patient and Caregiver Interviews
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- To know the experiences of patients who have participated in phase 3 clinical trial
研究概览
简要总结
Sanofi is evaluating fitusiran for the treatment of patients with hemophilia A or B, with and without inhibitors
Fitusiran is currently being evaluated in several phase 3 clinical trials (ATLAS-INH and ATLAS-A/B) and one open-label extension study (ATLAS-OLE)
In collaboration with Sanofi, RTI-HS has designed a stand-alone study in which telephone interviews will be conducted with up to 20 English-speaking participants (adult patients or parents/legal guardians of minors) from clinical sites in India that are participating in one or more of the ATLAS studies
Objective
•Obtain a better understanding of patients’ or caregivers’:
–Perception of treatment benefit (e.g., hemostatic protection, ambulation, joint functioning)
–Preferences for and satisfaction with hemophilia treatments, including fitusiran
–Experiences with hemophilia and its treatments prior to the ATLAS studies
•Data from the interviews will be used to:
–Obtain a better understanding of hemophilia and fitusiran
–Support publications
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who had participated in phase 3 would be selected from 3 sites.
- •By recruiting patients from multiple sites in India, it is anticipated that the interview substudy sample will be somewhat representative of the overall clinical trial population in India.
- •No patient (or caregiver) clinical or demographic characteristics will be targeted during sample selection.
排除标准
- 未提供
结局指标
主要结局
To know the experiences of patients who have participated in phase 3 clinical trial
时间窗: after 1 year of 1st recruitment
次要结局
- To know the experiences of patients who have participated in phase 3 clinical trial(after 1 year of 1st recruitment)