ENACT Study: Optimizing CF Treatment with Elexacaftor / Ivacaftor / Tezacaftor
This study, called ENACT, is looking at different ways to give the triple combination therapy of elexacaftor, ivacaftor, and tezacaftor to people with cystic fibrosis (CF). Researchers want to understand how these drugs work in your body and find the best dosing strategies. Some participants will also have their drug levels monitored to adjust their dose for the best effect. You may be able to join if you are at least 2 years old, have a confirmed CF diagnosis, and have been on a stable dose of this triple therapy for at least two weeks. The study aims to understand how drug levels relate to treatment success. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 100 participants. It will examine different dosing strategies for CFTR modulator therapy.
- What's involved
- For the therapeutic drug monitoring part, you might have up to six assessments over six months or more to adjust your dose. The observational part involves a one-time assessment.
- Compensation
- Not stated in the trial record.
- Follow-up
- For the therapeutic drug monitoring part, assessments will occur for up to six times over six months or more. For the observational part, there is a one-time assessment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Ensuring Access to Optimal Therapy in CF: The ENACT Study
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Jennifer S Guimbellot, Medical Degree and License · PRINCIPAL_INVESTIGATOR · Arkansas Children's Hospital Research Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Concentration (ng/mL)One time assessment for observational part of the study, up to 6 times (6 months or more) for the therapeutic drug monitoring pilot and feasibility study.
Drug concentration of CFTR modulators