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Can Drug-Level testing personalize cystic fibrosis treatment?

NCT ID NCT07809867

Knowledge-focused Sponsor: Istituto Giannina Gaslini Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

Researchers are studying how the cystic fibrosis drugs elexacaftor, tezacaftor and ivacaftor move through the body. The trial enrolls people aged 6 and older with cystic fibrosis who carry at least one F508del mutation and already take this drug combination. Participants keep their usual dosing schedule and give blood samples over up to 12 months so researchers can measure drug levels and look for links to side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of elexacaftor, tezacaftor and ivacaftor, three drugs that target the underlying protein defect in cystic fibrosis
What this could lead to
If the drug levels vary widely between people, this could support blood testing that helps doctors adjust doses for each patient.
What could go wrong
The study only measures drug levels and does not test whether changing doses helps anyone. Any dosing changes would still need separate trials to prove they improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Cystic Fibrosis patients with at least one F508del mutation treated with the combination elexacaftor/tezacaftor/ivacaftor 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. Exclusion Criteria: * 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 (see section 4 for details); * denial of the informed consent.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis (CF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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