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Real-World check: ivacaftor holds up for cystic fibrosis patients

NCT ID NCT02194881

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well the drug Ivacaftor works and how safe it is for people with cystic fibrosis who have a specific genetic change (G551D mutation) in everyday life, not just in a controlled trial. Researchers followed 57 French patients aged 6 and older for one year after the drug was approved. They measured lung function, hospital stays, and antibiotic use to see if the benefits seen in earlier studies continue in real-world settings.

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.

Participants

57 people

The number who actually took part.

Started

Oct 2014

Finished

May 2016

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.

Who is studied

Patients with CF aged 6 or older and cared in French CF centres

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: * French patients with CF aged 6 or older who are homozygous or heterozygous for the G551D mutation * Treated with Ivacaftor * First prescription of Ivacaftor before June 1st 2013 (including patients randomized in the VX770 clinical trials) Exclusion Criteria: * CF patients younger than 6 years old * CF patients who have received lung transplantation * CF patients without a G551D mutation.

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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

Contacts and locations

Locations

  • Hôpital Cochin

    Paris, 75014, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.