EUCTR2013-000604-41-IT进行中（未招募）1 期
A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- •? Subjects entering the Part A Treatment Cohort must have completed 24 weeks of study drug treatment in Study 103 or Study 104 and wish to enroll in the Part A Treatment Cohort.
- •? Subjects entering the Part A Observational Cohort must have completed at least 4 weeks of study drug treatment in Study 103 or in Study 104, or 24 weeks of study drug treatment in Study 103 or Study 104, but do not wish or do not qualify to enroll in the Part A Treatment Cohort.
- •? Treatment Cohort Subjects entering the Part B Treatment Cohort must have completed 56 days of study drug treatment in Cohort 4 of Study 102 and wish to enroll in the Part B Treatment Cohort.
- •? Willing to remain on a stable CF medication regimen through the end of study (Treatment Cohort only).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 389
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 611
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Any comorbidity or lab abnormality that might confound the results of the study or pose an additional risk in administering study drug to the subject.
- •? Pregnant and nursing females, sexually active subjects of reproductive potential who are not willing to follow the contraception requirements.
- •? History of drug intolerance in prior study that would pose an additional risk to the subject.
- •? History of poor compliance with study drug and/or procedures in prior study.
- •? Subjects may not participate in an investigational drug study until the completion of this study.
研究者
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