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Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor Long-term Safety and Efficacy in Subjects Without F508del
EU CTIS ID: 2024-515637-14-00
What this study is testing
Part A and B: To evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 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.
- Did not withdraw consent from the parent study.
- Part A: Meets at least 1 of the following criteria: • Completed study drug treatment in the parent study. • Had study drug interruption(s) in the parent study, but completed study visits up to the last scheduled visit of the Treatment Period of the parent study. Part B: Meets at least 1 of the following criteria: • Completed study drug treatment in Part A. • Had study drug interruption(s) in Part A, but completed study visits up to the last scheduled visit of the Treatment Period of Part A.
- Willing to remain on a stable CF treatment regimen (other than CFTR modulators, as defined in Section 9.5) through completion of study participation.
You likely can't join if
- 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.
- History of drug intolerance in the 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).
- Pregnant and nursing females. Females of childbearing potential (Section 11.5.6.1) must have a negative pregnancy test at the Day 1 Visit (in Part A and Part B) before receiving the first dose of study drug.
- Current participation in an investigational drug trial (other than the 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.