NCT00043342已完成1 期
A Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic Fibrosis
InterMune0 个研究点目标入组 51 人开始时间: 2002年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 主要终点
- change in sputum neutrophil count
研究概览
简要总结
The purpose of this research study is to evaluate the safety, tolerability, and efficacy of Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period of 4 weeks to patients with mild-to-moderate cystic fibrosis. Additionally, preliminary assessments on the effects of IFN-gamma 1b on lung function and other indicators of health will be made.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 years of age
- •Diagnosis of cystic fibrosis (against certain criteria)
- •Able to perform pulmonary (lung) function tests and participate in induced sputum procedures
- •Pulmonary function values must meet certain minimal requirements
- •Must have acceptable laboratory test results
- •Cannot be on certain medications during and immediately prior to study
- •Cannot have a history of unstable or deteriorating cardiac or neurologic disease
排除标准
- 未提供
结局指标
主要结局
change in sputum neutrophil count
时间窗: 4 weeks
次要结局
- change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8(4 weeks)
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