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Population Pharmacokinetics of Elexacaftor-tezacaftor-ivacaftor in a Paediatric Population

Recruitingn/aAges 2 Years - 17 YearsAllHospices Civils de Lyon
NCT07303621 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Cystic fibrosis is a rare, progressive genetic disease caused by a mutation in the CFTR (cystic fibrosis transmembrane conductance regulator) gene. Respiratory and nutritional effects are crucial to patients' prognosis. Since the early years of 2010, etiological treatment has been based on the use of CFTRm (CFTR modulator), which aim to restore the function of the mutated protein. Initially used as monotherapy and targeting a limited number of patients, CFTRm has gradually been extended to a larger number of patients, to the point where it now concerns 9 out of 10 patients, through the use of triple therapy with Elexacaftor-Tezacaftor-Ivacaftro (ETI) or Kaftrio(R). The efficacy of triple therapy is spectacular, revolutionizing the prognosis of the disease. However, the potential for neuropsychological side-effects (20-50% depending on age, but more frequent in young children under 5) an

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📋 Eligibility rules (as published)
Inclusion Criteria: * Children aged 2 to 17 years old * Having Cystic Fibrosis * Treated by Elexacaftor/Tezacaftor and Ivacaftor (Trikafta® or Kaftrio®) Exclusion Criteria: * Allergy to previous CFTR modulator association (Ivacaftor, lumacaftor) * Pregnant women * Patient already enrolled in another study with CYP3A4 inhibitor * Pulmonary transplant recipient
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What it tests

  • There is no intervention as this is a prospective pharmacokinetics study.
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Where

1 site
Hôpital Femme Mère Enfant (HFME)
Bron, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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