EUCTR2015-004986-99-IT进行中（未招募）1 期
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients with Cystic Fibrosis (CF) Being Treated for an Exacerbation of CF-associated Lung Disease.
ovaBiotics, Ltd0 个研究点目标入组 120 人开始时间: 2016年9月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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-associated lung disease with documented history of chronic infection with Gram-negative organism(s)
- •2. Established patient of the Principal Investigator's CF Multi-Disciplinary team
- •3. Age equal or greater than 18 years
- •4. Weight equal or more than 40 Kg
- •5. FEV1 more than 30% of predicted within the 6 months prior to study exacerbation
- •6. At baseline visit: experiencing a new exacerbation of CF associated lung disease requiring treatment that includes an aminoglycoside antibiotic
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Hypersensitive to cysteamine or to any of the excipients
- •2. Hypersensitive to penicillamine
- •3. Transplant recipient
研究者
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A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.exacerbation of Cystic FibrosisEUCTR2015-004986-99-GBovaBiotics, Ltd120
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