NCT03761082已完成不适用
Post Marketing Surveillance of PIRESPA® TAB 200mg (Pirfenidone) for Evaluating the Safety and Efficacy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 主要终点
- The change from baseline to week 48 in the percentage of the predicted FVC
研究概览
简要总结
Post-marketing surveillance of Pirfenidone
详细描述
Pirfenidone (Pirespa®) is an anti fibrotic drug, which was approved in 2012 in the Republic of Korea for the treatment of patients with idiopathic pulmonary fibrosis (IPF). A post-marketing survey was conducted following the approval to obtain data on the safety and efficacy of pirfenidone for IPF treatment in real-world practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Among patients diagnosed as idiopathic pulmonary fibrosis, only those who have used the testing drug under the general medical conditions for a certain investigation period after the beginning of the investigation and also signed a the "Personal Information Utilization Agreement" form. However, for those who have already received the drug before the beginning of the investigation, only the subjects whose medical record can be used are included.
排除标准
- •Subjects who is hypersensitive to the active ingredient or additives of this drug
- •Subjects who have severe hepatopathy
- •Subjects who have severe renal disorder (creatinine clearance<30mL/min) or a terminal renal disease treated by dialysis
- •Subjects who received a combined treatment of fluvoxamine
- •Subjects who have genetic problems, such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
结局指标
主要结局
The change from baseline to week 48 in the percentage of the predicted FVC
时间窗: up to 48 weeks
In case of administering this drug for more than 12 weeks after registration in the investigation, response evaluation is conducted every 12 weeks (12,24,36,48 weeks) and records are investigated before administration of this drug and after 12, 24,36,48 weeks of administration.
次要结局
- Incidence of adverse event after this drug administration in general medical(48 weeks)
研究者
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