EUCTR2021-005066-17-PL进行中（未招募）1 期
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 94
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •-Male and female participants at least 40 years of age
- •-IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines
- •-FVC =45% predicted
- •-DLCO, corrected for hemoglobin, =25% predicted (inclusive)
- •-Unlikely to undergo lung transplantation during this trial in the opinion of the investigator
- •-If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization
- •Additional protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 47
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 47
排除标准
- •-Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening
- •-Emphysema >20% on screening HRCT
- •-Fibrosis <10% on screening HRCT
- •-Clinical diagnosis of any connective tissue disease
- •-Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization
- •Additional protocol-defined exclusion criteria may apply.
研究者
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