NCT01417156已完成2 期
A Phase II Open Label, Follow up Study to Investigate the Long Term Tolerability and Safety of Oral BIBF 1120 on Top of Pirfenidone in Japanese Patients With Idiopathic Pulmonary Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Overall Adverse Events
研究概览
简要总结
Primary objective of this study is to investigate the long-term tolerability and safety profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31).
Secondary objectives are to assess effects on some efficacy criteria during long term treatment with BIBF 1120 on top of pirfenidone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
All patients
Experimental
干预措施: Nintedanib (Drug)
All patients
Experimental
干预措施: Pirfenidoneone (Drug)
结局指标
主要结局
Incidence of Overall Adverse Events
时间窗: First drug administration until end of treatment, up to 5 years
Incidence (Number of patients) of Adverse events (AEs) over the course of treatment period including serious adverse events (SAEs), AEs leading to discontinuation of study medication, and fatal AEs.
次要结局
- Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.(First drug administration until end of treatment, up to 5 years)
- Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)(Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years)
- Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.(Week 234)
- Annual Rate of Decline in Forced Vital Capacity (FVC).(Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years)
研究者
研究点 (1)
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