A low-intervention prospective-retrospective study to evaluate the pharmacokinetics of elexacaftor/tezacaftor/ivacaftor combination in a Cystic Fibrosis population
EU CTIS ID: 2024-518785-28-00
What this study is testing
To determine plasma profiles of ELX, TEZ and IVA when administered in combination.
- Therapeutic use (Phase IV)
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
- CF patients with at least one F508del mutation treated with the combination ETI for a time sufficient to reach steady-state (8 days).
- Males and females aged ≥6 years.
- Informed consent to participate in the study and to process the patient's personal data obtained prior to the collection of any study data.
You likely can't join if
- Evidence of inadequate compliance to treatment.
- Pregnancy and/or breastfeeding.
- Any conditions that may affect the ability to complete informed consent.
- Any other severe systemic disorders that may compromise the PK parameters.
- Use of any drug capable of moderately/strongly inhibiting or strongly inducing hepatic biotransformation.
- Denial of the informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Italy
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, but 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, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.