跳至主要内容
临床试验/NL-OMON56478
NL-OMON56478尚未招募不适用

Getting insight in the exposure effect relationship of Elexacaftor/ Tezacaftor/Ivacaftor treatment in people with cystic fibrosis - The exposure effect relationship of ETI treatment in pwCF

HagaZiekenhuis0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • In order to be eligible to participate in this study, a subject must meet all
  • of the following criteria:
  • 1.Cystic fibrosis based on DBC code ( specialisme: 0322 ; Diagnose: 1403)
  • 2.Use of Kaftrio tablets with dosage of 75/5-/100mg and ATC code: R07AX32
  • 3.Use of standard dose of ETI (2 tablets in the morning) and Ivacaftor (1
  • tablet in the evening).
  • 4.Availability of a baseline and on ETI treatment sweat chloride value
  • 5.A homozygous F508del mutation in the CFTR gene
  • 6.A stable clinical condition defined as no pulmonary exacerbation in a period
  • of 4 weeks before study visit

排除标准

  • A potential subject who meets any of the following criteria will be excluded
  • from participation in this study:
  • 1. Solid organ transplantation
  • 2. The use of concomitant medications with CYP3A4 interactions during the
  • period of determining the trough concentration of ETI
  • 3. Pregnancy
  • 4. Liver cirrhosis

研究者

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