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New treatment option for Cystic Fibrosis
Official title Intestine-lung Axis of Cystic Fibrosis Patients Treated With the Combination Elexacaftor/Tezacaftor/Ivacaftor
ClinicalTrials.gov ID: NCT05937815
What this study is testing
- What it's testing
- Cystic fibrosis is a systemic disease, which affects in particular the respiratory and digestive systems of patients, sites of chronic inflammation. A new combination of elexacaftor/tezacaftor/ivacaftor has proven its efficacy for the treatment of patients aged 12 years and over with two F508del mutations or a so-called "minimal function" mutation associated with one F508del mutation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- To have cystic fibrosis (sweat test \> 60 mmol/l);
- Carrier of at least one DeltaF508 mutation;
- Be followed in the current care by a participant in the CRCM study;
- Start treatment with elexacaftor/tezacaftor/ivacaftor in routine care, according to the indications in the Marketing Authorization at the time of...
- Be of the age specified in the marketing authorization in force;
You likely can't join if
- Start of treatment with elexacaftor/tezacaftor/ivacaftor as part of a therapeutic trial.
- Patient already on CFTR modulator (including lumacaftor/ivacaftor)
- Vulnerable people (pregnant woman, person under guardianship/curators)
See the full eligibility criteria
- To have cystic fibrosis (sweat test \> 60 mmol/l);
- Carrier of at least one DeltaF508 mutation;
- Be followed in the current care by a participant in the CRCM study;
- Start treatment with elexacaftor/tezacaftor/ivacaftor in routine care, according to the indications in the Marketing Authorization at the time of inclusion;
- Be of the age specified in the marketing authorization in force;
- Person affiliated or beneficiary of a social security scheme;
- Consent obtained by the patient (for adult patients) or the holders of parental authority (for minor patients) before any examination required by the research and oral and/or written consent by the participant...
- Patient agreeing to take part in cohort follow-up studies of patients treated with elexacaftor/tezacaftor/ivacaftor, included in the French cystic fibrosis register (cf. Study by Pr BURGEL and/or MODUL CF).
- Start of treatment with elexacaftor/tezacaftor/ivacaftor as part of a therapeutic trial.
- Patient already on CFTR modulator (including lumacaftor/ivacaftor)
- Vulnerable people (pregnant woman, person under guardianship/curators)
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nancy, France
- Nice, France
- Paris, France
- Roscoff, France
- Rouen, France
- Toulouse, France
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 - 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, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Grenoble, France; Lille, France; Limoges, France; Lyon, France; Marseille, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.