NCT01266135终止2 期
Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in forced vital capacity (FVC) at 52 weeks as compared to baseline
研究概览
简要总结
This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 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
Arm 1: QAX576 10 mg/kg
Experimental
干预措施: QAX576 (Drug)
Arm 2: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in forced vital capacity (FVC) at 52 weeks as compared to baseline
时间窗: 1 year
Measure: FVC was measured using a spirometer according to American Thoracic Society / European Respiratory Society guidelines at screening and week 52 of the treatment period.
To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF
时间窗: 1 year
Safety and tolerability of QAX576.
时间窗: 1 year
Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.
次要结局
- To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy(1 year)
- To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood(1 year)
- Pharmacokinetics of QAX576(1 year)
- Time to clinical worsening:(1 year)
- Exacerbation of IPF(1 year)
- Progression of fibrosis(1 year)
研究者
研究点 (1)
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