NCT00004806已完成1 期
Phase I Study of Liposome-Mediated Gene Transfer in Patients With Cystic Fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
OBJECTIVES:
Evaluate the efficacy and safety of lipid-mediated transfer of the cystic fibrosis transmembrane conductance regulator gene to nasal epithelium in patients with cystic fibrosis.
详细描述
PROTOCOL OUTLINE: Cystic fibrosis transmembrane conductance regulator (CFTR) gene complexed with lipid is administered intranasally to the right inferior turbinate. Lipid without CFTR is administered to the left nostril as a control.
Cohorts of 3 patients are given successively lower doses of CFTR, each dose complexed with 500 micrograms of lipid.
Patients are followed at days 2-12, 15, and 21, then every 3-4 days for 3 weeks, every 2-3 weeks for 10 weeks, and every 3 months thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（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
研究者
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