A Phase 3 Open-label Study Evaluating the Longterm Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes - Study to Evaluate Elx/Tez/Iva Long-term Safety and Efficacy in Subjects Without F508del

Vertex Pharmaceuticals Incorporated0 个研究点目标入组 270 人开始时间: 2022年4月22日最近更新: 2023年12月4日

研究概览

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•1. Subject (or the subject’s legally appointed and authorized representative) will sign and date an informed consent form (ICF) and, when appropriate, an assent form.
•2. Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines (as applicable), and other study procedures.
•- For subjects <18 years of age: as judged by the investigator, parent or legal guardian must be able to understand protocol requirements, restrictions, and instructions and the parent or legal guardian should be able to ensure that the subject will comply with and is likely to complete the study as planned.
•3. Did not withdraw consent from a parent study.
•4. Meets at least 1 of the following criteria:
•- Completed study drug treatment in a parent study.
•- Had study drug interruption(s) in a parent study, but completed study visits up to the last scheduled visit of the Treatment Period of a parent study.
•5. Willing to remain on a stable CF treatment regimen (other than CFTR modulators, as defined in Section 9.5) through completion of study participation.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 150
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. History of any illness or any clinical condition that might confound the results of the study or pose an additional risk in administering study drug(s) to the subject.
•2. History of drug intolerance in a parent study that would pose an additional risk to the subject. (e.g., subjects with a history of allergy or hypersensitivity to the study drug).
•3. Pregnant and nursing females. Females of childbearing potential (Section 11.5.6.1) must have a negative pregnancy test at the Day 1 Visit before receiving the first dose of study
•4. Current participation in an investigational drug trial (other than a parent study). Participation in a noninterventional study (including observational studies, registry studies, and studies requiring blood collections without administration of study drug) and screening for another Vertex study is permitted.

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