A Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 435
- 试验地点
- 1
- 主要终点
- Absolute Change in Percent Predicted Forced Vital Capacity (FVC)
研究概览
简要总结
The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.
详细描述
This is a Phase 3, randomized, double blind, placebo-controlled, three-arm, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis. Approximately 400 patients at approximately 70 centers will be randomly assigned (2:2:1) to receive either 2403 milligrams (mg) of pirfenidone, placebo equivalent, or 1197 mg of pirfenidone administered in divided doses three times per day (TID) with food. Patients will be randomized by geographic region.
Patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks. A Data Monitoring Committee (DMC) will periodically review safety and efficacy data to ensure patient safety.
After week 72, patients who meet the Progression of Disease (POD) definition, which is a ≥ 10% absolute decrease in percent predicted FVC or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive permitted IPF therapies in addition to their blinded study drug. Permitted IPF therapies include corticosteroids, azathioprine, cyclophosphamide and N-acetyl-cysteine (with restrictions).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
2403 mg/day pirfenidone
Active arm 1, 2403 mg/day pirfenidone dose group.
干预措施: Pirfenidone (Drug)
1197 mg/day pirfenidone
Active arm 2, 1197 mg/day pirfenidone.
干预措施: Pirfenidone (Drug)
placebo
Placebo equivalent.
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute Change in Percent Predicted Forced Vital Capacity (FVC)
时间窗: From baseline up to 72 weeks
Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.
次要结局
- Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs(Baseline to Week 72)
- Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test(Baseline to Week 72)
- Change in Dyspnea Score(Baseline to Week 72)
- Worsening of Idiopathic Pulmonary Fibrosis (IPF)(Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.)
- Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)(baseline up to 72 weeks)
- Progression-free Survival (PFS)(Baseline to Week 72)
- Change in Six-Minute Walk Test (6MWT)Distance(Baseline to Week 72)