EUCTR2014-000284-40-GB进行中（未招募）1 期
An open label investigation of the tolerability and pharmacokinetics of oral cysteamine in adults with Cystic Fibrosis. - Cysteamine in Cystic Fibrosis (2)
niversity of Aberdeen0 个研究点目标入组 12 人开始时间: 2014年4月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.CF related suppurative lung disease who expectorate sputum
- •2.Clinically stable for >4 weeks,
- •3.Aged =18 years,
- •4.Weight >50kg.
- •5.Female participants of child bearing potential should be using a reliable form of contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1.Hypersensitivity to the active substance, any form of cysteamine, or to any of the excipients.
- •2.Hypersensitivity to penicillamine.
- •3.Lung, liver transplant, on active transplant list.
- •4.For women, current pregnancy or breast-feeding, or planned pregnancy during the study.
- •5.Any other significant disease/disorder which, in the investigator’s opinion, either puts the patient at risk because of study participation or may influence the results of the study or the patient's ability to participate in the study.
研究者
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