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Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Subjects 2 Years and Older
EU CTIS ID: 2024-515606-90-00
What this study is testing
To evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in cystic fibrosis (CF) subjects 2 years of age and older
- 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
- Part A: Subject’s legal representative or guardian will sign and date an informed consent form (ICF).
- Part B: Willing to remain on a stable CF treatment regimen (as defined in Section 9.5) through completion of study participation
- Part A: As judged by the investigator, the legal representative or guardian must be able to understand protocol requirements, restrictions, and instructions and the legal representative or guardian should be able to ensure that the subject will comply with and is likely to complete the study as planned
- Part A: 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, 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.
- Part A: Willing to remain on a stable CF treatment regimen (as defined in Section 9.5) through completion of study participation.
You likely can't join if
- Part A: 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. This includes, but is not limited to, the following: • Clinically significant liver cirrhosis with or without portal hypertension • Solid organ or hematological transplantation • Cancer
- Part B: History of poor compliance with ELX/TEZ/IVA and/or procedures in the parent study or Part A, as deemed by the investigator.
- Part B: Use of restricted medication, as defined in Table 9-1, unless subject is on a study drug interruption at the time of rollover.
- Part B: The subject or a close relative of the subject is the investigator or a sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study at that site.
- Part A: 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).
- Part A: 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.
See the full eligibility criteria
Who can join
- Part A: Subject’s legal representative or guardian will sign and date an informed consent form (ICF).
- Part B: Willing to remain on a stable CF treatment regimen (as defined in Section 9.5) through completion of study participation
- Part A: As judged by the investigator, the legal representative or guardian must be able to understand protocol requirements, restrictions, and instructions and the legal representative or guardian should be able to ensure that the subject will comply with and is likely to complete the study as planned
- Part A: 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, 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.
- Part A: Willing to remain on a stable CF treatment regimen (as defined in Section 9.5) through completion of study participation.
- Part B: Subject’s legal representative or guardian will sign and date an ICF.
- Part B: As judged by the investigator, the legal representative or guardian must be able to understand protocol requirements, restrictions, and instructions and the legal representative or guardian should be able to ensure that the subject will comply with and is likely to complete the study as planned.
- Part B: Did not withdraw consent in Part A.
- Part B: Meets at least 1 of the following criteria: • Completed study drug treatment in Part A, or • Had study drug interruption(s) in Part A, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of Part A.
What rules you out
- Part A: 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. This includes, but is not limited to, the following: • Clinically significant liver cirrhosis with or without portal hypertension • Solid organ or hematological transplantation • Cancer
- Part B: History of poor compliance with ELX/TEZ/IVA and/or procedures in the parent study or Part A, as deemed by the investigator.
- Part B: Use of restricted medication, as defined in Table 9-1, unless subject is on a study drug interruption at the time of rollover.
- Part B: The subject or a close relative of the subject is the investigator or a sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study at that site.
- Part A: 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).
- Part A: 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.
- Part A: History of poor compliance with ELX/TEZ/IVA and/or procedures in the parent study as deemed by the investigator.
- Part A: Use of restricted medication, as defined in Table 9-1, unless subject is on a study drug interruption at the time of rollover.
- Part A: The subject or a close relative of the subject is the investigator or a sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study at that site.
- Part B: History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject.
- Part B: History of drug intolerance in the parent study or Part A that would pose an additional risk to the subject in the opinion of the investigator (e.g., subjects with a history of allergy or hypersensitivity to the study drug).
- Part B: Current participation in an investigational drug trial other than the parent study or the current 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
- United States
- Canada
- United Kingdom
- Australia
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; United Kingdom; Australia. 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.