NCT00047645已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis
InterMune2 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2000年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Progression-free survival time
研究概览
简要总结
Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b administered by subcutaneous injection; compared to placebo in patients with IPF who are unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g 1b group or a placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, 20-79 years old
排除标准
- 未提供
结局指标
主要结局
Progression-free survival time
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (2)
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