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Modulate-CF: Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulators

Recruitingn/aAges 6 Months - anyAllCharite University, Berlin, Germany
NCT04732910 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This observational study evaluates the effect of therapy with cystic fibrosis transmembrane regulator (CFTR) modulators on CFTR function measured by the CFTR biomarker intestinal current measurement (ICM), nasal potential difference (NPD) and sweat chloride in a post-approval setting in patients with cystic fibrosis (CF).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Decision for cystic fibrosis (CF) transmembrane regulator (CFTR)-modulator therapy by the patient and the caring CF physician * Signed informed consent form (ICF) and, where appropriate, signed assent form. Exclusion Criteria: * Ongoing participation in an investigational drug study (including studies investigating lumacaftor, tezacaftor or ivacaftor)
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What it tests

  • Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor-Ivacaftor, Tezacaftor-Ivacaftor, Elexacaftor-Tezacaftor-Ivacaftor, Vanzacaftor-Tezacaftor-Deutivacaftor
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Where

4 sites
Charité - Universitätsmedizin Berlin
Berlin, Germany
Justus-Liebig-University Giessen
Giessen, Germany
Hannover Medical School
Hanover, Germany
University of Heidelberg
Heidelberg, Germany
🤝 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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