NCT02552849已完成不适用
Observational Study to Evaluate Disease Course and Outcomes in Patients Treated With Esbriet (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF) in Canada
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 26
- 主要终点
- Change in Observed Predicted Forced Vital Capacity
研究概览
简要总结
This is a multi-center, non-interventional study to assess and describe course and outcomes in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet (pirfenidone) in Canada, by measuring and reporting observed predicted forced vital capacity (FVC) change from baseline on an ongoing basis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> or = 18 years of age
- •Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
- •Prescribed and/or currently taking Esbriet (pirfenidone) for the treatment of IPF
排除标准
- •Hypersensitivity to Esbriet (pirfenidone)
- •Concomitant use of fluvoxamine
- •Severe hepatic impairment or end-stage liver disease
- •Severe renal impairment or end-stage renal disease requiring dialysis
结局指标
主要结局
Change in Observed Predicted Forced Vital Capacity
时间窗: Up to 4 years
次要结局
- Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)(Up to 4 years)
- Progression-Free Survival (PFS)(Up to 4 years)
- Proportion of Patients Taking Full Dose of Esbriet (pirfenidone)(Up to 4 years)
- Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone)(Up to 4 years)
- Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the A Tool Quality of Life Questionnaire (ATAQ-IPF)(Up to 4 years)
- Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Health-Related Quality of Life Questionnaire (HRQOL)(Up to 4 years)
- Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH)(Up to 4 years)
- Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the EuroQol-5 Dimension Questionnaire (EQ-5D)(Up to 4 years)
研究者
研究点 (26)
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