NCT06485635已完成不适用
Real-life-Persistence to Antifibrotic Treatments
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,646
- 试验地点
- 2
- 主要终点
- Persistence to antifibrotic (AF) treatment (measured as percentage of patients still treated up to 30 months after AF treatment initiation)
研究概览
简要总结
This study will help to better understand the persistence rate to antifibrotic (AF) treatment in real life in France and to identify potential areas for improvement by investigating the factors associated with a non-persistence rate to AF treatment.
Primary objective of the study is to measure the percentage of patients still treated up to 30 months after AF treatment initiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.
排除标准
- •No exclusion criteria will be applied.
研究组 & 干预措施
Patients with a reimbursement of AF treatment
干预措施: Nintedanib (Drug)
Patients with a reimbursement of AF treatment
干预措施: Pirfenidone (Drug)
结局指标
主要结局
Persistence to antifibrotic (AF) treatment (measured as percentage of patients still treated up to 30 months after AF treatment initiation)
时间窗: up to 30 months
次要结局
- AF incidence in French population(up to 4 years)
- Number of AF treated patients split by indication(up to 2 years)
- Number of patients adherent to AF treatment(up to 30 months)
- Percentage of the target cumulative dose of treatment received by the patients(up to 30 months)
- Influence of factors (yes/no) associated with persistence to AF treatments(up to 30 months)
- Number of patients at site of follow-up (identified as 2 lung function tests performed in the center)(up to 5 years)
- Overall Survival (defined as time from index date (first reimbursement of AF treatment) to death from any cause)(up to5 years)
- Event-free survival(up to 5 years)
- AF prevalence in French population(up to 5 years)
- Number of patients with switch from one AF treatment to the another with no treatment stop(up to 5 years)
研究者
研究点 (2)
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