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.

NCT07148739

Ensuring Access to Optimal Therapy in CF: The ENACT Study

Recruiting
PHASE4Ages 3+InterventionalTreatment
Arkansas Children's Hospital Research Institute
~100 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Elexacaftor / Ivacaftor / Tezacaftortherapeutic drug monitoring

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concentration (ng/mL)
Measured over 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.
Cystic Fibrosis (CF)
3 sites across 3 states
Alabama1
Arkansas1
Washington1
  • Jennifer S Guimbellot, Medical Degree and License · PRINCIPAL_INVESTIGATOR · Arkansas Children's Hospital Research Institute
Jennifer S Guimbellot, Medical Degree and License
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

documentation of CF diagnosis per CFF diagnostic criteria and known CFTR genotype
age 2 years and older
ability to provide written informed consent and/or assent (by subject and/or legal guardian)
on a stable dose of triple combination CFTR modulator therapy for at least two weeks prior to Visit 1
clinically stable lung disease, defined as no documented acute decrease in FEV1 \> 10%, OR use of additional antibiotics (intravenous \[IV\] or oral \[PO\]) within 4 weeks prior to screening

Exclusion

recent significant unintentional weight loss, as determined by the investigator, in the 4 weeks prior to screening
pregnant or breastfeeding female
history of alcohol or substance abuse in the 6 months prior to screening
participation in a study involving an investigational intervention within 28 days (or 5 half-lives, whichever is longer) prior to screening
in the opinion of the Investigator, medical or psychiatric illness, or other conditions that would interfere with participation
  • 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