NCT03902509已完成2 期
A Randomized, Controlled, Multi-site Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
Beijing Continent Pharmaceutical Co, Ltd.2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2019年5月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- DLco% change
研究概览
简要总结
Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.
详细描述
The study is a randomized, controlled, multi-site clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old (including 18 and 75 years);
- •clinically diagnosed grade 2 or 3 radiation-induced lung injury;
- •the course of radiation-induced lung injury is less than 2 months;
- •the expected survival time is more than 6 months;
- •the functional level of major organs meets the following standards: ANC≥3.0×109/L，PLT≥100×109/L，Hb≥90g/L, TBIL、BUN and Cr≤1.5×ULN， ALT、AST≤2.0×ULN
- •capable of eating solid food upon enrollment;
- •subjects will voluntarily participate in this study and sign the informed consent.
排除标准
- •have a history of chronic bronchial acute attack or severe pulmonary heart disease;
- •pneumonectomy;
- •tumor progression;
- •severe pulmonary infection;
- •creatinine clearance rate < 30ml/min, severe renal disease or need dialysis;
- •concomitant with other serious diseases: for example, myocardial infarction within 6 months, uncontrolled diabetes, etc., were considered not suitable for the participants in the study;
- •patients with active peptic ulcer;
- •pregnant women and patients with mental illness;
- •participating in clinical trials of other drugs within 3 months;
- •the investigator determined that subject was not suitable.
研究组 & 干预措施
Pirfenidone
Experimental
pirfenidone + basic treatment
干预措施: Pirfenidone (Drug)
Pirfenidone
Experimental
pirfenidone + basic treatment
干预措施: basic treatment (Drug)
Controll
Other
with basic treatment and without pirfenidone treatment
干预措施: basic treatment (Drug)
结局指标
主要结局
DLco% change
时间窗: Week 4, 8,16, and 24
Compare DLco% from basement to the end of treatment
次要结局
- The score change of CT(Week 4, 8,16, and 24)
- Increase of effective lung volume(Week 4, 8,16, and 24)
- The grade change of Cough, Dyspnea and Fever(Week 4, 8,16, and 24)
- The grade change of radiation-induced lung injury(Week 4, 8,16, and 24)
研究者
研究点 (2)
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