NCT01366209已完成3 期
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 555
- 试验地点
- 1
- 主要终点
- Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52
研究概览
简要总结
PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2011 Guidelines, of 6-48 months' duration
- •Age 40 to 80 at randomization
- •Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening
- •Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening
排除标准
- •Forced expiratory volume in one second (FEV1)/FVC ratio <0.8 after administration of bronchodilator at Screening
- •Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
- •Known explanation for interstitial lung disease
- •History of asthma or chronic obstructive pulmonary disease
- •Active infection
- •Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
- •History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
研究组 & 干预措施
Active Arm
Active Comparator
干预措施: Pirfenidone (Drug)
Placebo Arm
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52
时间窗: 52 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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