EUCTR2014-004837-13-ES进行中（未招募）1 期
A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 510
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
- •Homozygous for the F508del CFTR mutation, genotype to be confirmed at the Screening Visit
- •Confirmed diagnosis of CF defined as a sweat chloride value = 60 mmol/L by quantitative pilocarpine iontophoresis
- •FEV1 = 40% and = 90% of predicted normal for age, sex, and height during screening
- •Stable CF disease as judged by the investigator
- •Willing to remain on a stable CF medication regimen through Week 24 or, if applicable, the Safety Follow up Visit
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 122
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 368
- •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 comorbidity 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 28 days before Day 1 (first dose of study drug)
- •Pregnant or nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Day 1)
- •Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
研究者
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