EUCTR2013-000604-41-ES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
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 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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