EUCTR2009-010261-23-Outside-EU/EEA进行中（未招募）不适用
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of VX-770 in Subjects Aged 12 Years and Older With Cystic Fibrosis who are Homozygous for the F508del-CFTR Mutation - DISCOVER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •- Male or female with confirmed diagnosis of CF
- •- Must be homozygous for the F508del-CFTR mutation.
- •- FEV1 40% or greater of predicted normal
- •- 12 years of age or older
- •- Females of child-bearing potential must have a negative serum pregnancy test at Screening
- •- Subjects of child-bearing potential and who are sexually active must meet the contraception requirements
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
- •- An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before Day 1
- •- History of solid organ or hematological transplantation
- •- History of alcohol, medication, or illicit drug abuse within one year prior to Day 1
- •- Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to Screening.
- •- Use of inhaled hypertonic saline treatment.
- •- Concomitant use of any inhibitors or inducers of CYP3A4
研究者
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