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

Recruiting now

Conditions studied: Cystic Fibrosis

In brief

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).

Key facts

Study ID

NCT04732910

Run by

Charite University, Berlin, Germany

People needed

500

Starts

2018-07-01

Expected to finish

2027-12-31

Last updated by the study team

2026-02-24

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Ongoing participation in an investigational drug study (including studies investigating lumacaftor, tezacaftor or ivacaftor)

Where it is running

• Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (enrolling)
• Justus-Liebig-University Giessen — Giessen, Germany (enrolling)
• Hannover Medical School — Hanover, Germany (enrolling)
• University of Heidelberg — Heidelberg, Germany (enrolling)

Full record on ClinicalTrials.gov

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