NCT06460506进行中（未招募）3 期
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 Months of Age and Older
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 35
- 主要终点
- Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed study drug treatment in the parent study VX22-445-122 Part B (NCT05882357) OR had study drug interruption(s) in the parent study but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the Treatment Period of the parent study
排除标准
- •History of drug intolerance in the parent study that would pose an additional risk to the participant
- •Current participation in an investigational drug trial other than the parent study
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
ELX/TEZ/IVA
Experimental
Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.
干预措施: IVA (Drug)
ELX/TEZ/IVA
Experimental
Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.
干预措施: ELX/TEZ/IVA (Drug)
结局指标
主要结局
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Day 1 up to Week 100
次要结局
- Absolute Change in Sweat Chloride (SwCl)(From Baseline through Week 96)
研究者
研究点 (35)
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