EUCTR2012-000389-39-BE进行中（未招募）1 期
A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-TermIvacaftor Treatment in Subjects 6 Years of Age and Older with CysticFibrosis and a Non-G551D 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
- 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
- •- Subjects entering the ivacaftor arm must have completed the assigned study drug treatment duration in the previous study (Study 110 or Study 111), must have completed the previous study but do not wish to enroll in the ivacaftor arm, or must have completed the previous study but do not meet the inclusion criteria of the ivacaftor arm.
- •- Subjects entering the observational arm must have completed at least
- •4 weeks of study drug treatment in their previous study (Study 110 or Study 111)
- •- Females of childbearing potential entering the ivacaftor arm must not be pregnant
- •- Subjects entering the ivacaftor arm must be willing to comply with contraception requirements
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 31
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 87
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Ivacaftor Arm Only:
- •- History of any illness or condition that might confound the results of
- •the study or pose an additional risk in administering ivacaftor to the
- •- Use of any inhibitors or inducers of cytochrome P450 (CYP) 3A
- •- Evidence of cataract or lens opacity at or before the Day 1 Visit
研究者
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