jRCT2021240008进行中（未招募）不适用
An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) (FIBRONEER-ON)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 主要终点
- adverse event occurrence
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •Patients with IPF who have completed 1305-0014 trial on blinded treatment and patients with PPF who have completed 1305-0023 trial on blinded treatment (i.e. who did not prematurely discontinue trial treatment permanently in parent trials) and do not have any contraindication to treatment with BI 1015550
排除标准
- •Patients with IPF who have completed 1305-0014 trial on blinded treatment and patients with PPF who have completed 1305-0023 trial on blinded treatment (i.e. who did not prematurely discontinue trial treatment permanently in parent trials) and do not have any contraindication to treatment with BI 1015550
结局指标
主要结局
adverse event occurrence
时间窗: up until the follow-up/end of study visit planned at week 99
whether a patient had any adverse event over the course of the extension trial (yes/no)
次要结局
- Absolute change from baseline in FVC (mL) and in % predicted FVC over time(over time)
- Time to absolute decline in FVC % predicted of >10% from baseline(over the duration of the trial)
- Time to first acute IPF/PPF exacerbation, first hospitalisation for respiratory cause, or death(over the duration of the trial)
- Time to first acute IPF/PPF exacerbation or death(over the duration of the trial)
- Time to hospitalisation for respiratory cause or death(over the duration of the trial)
- Time to absolute decline in FVC % predicted of more than10% from baseline or death(over the duration of the trial)
- Time to relative decline in FVC % predicted of more than 10% from baseline or death(over the duration of the trial)
研究者
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