Actively Recruiting

Age: 6Months +
All Genders
NCT04732910

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

Led by Charite University, Berlin, Germany · Updated on 2026-02-24

500

Participants Needed

4

Research Sites

495 weeks

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

H

Hannover Medical School

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Decision for cystic fibrosis transmembrane regulator (CFTR) modulator therapy by the patient and the caring CF physician
  • Signed informed consent form (ICF) and, where appropriate, signed assent form.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany, 13353

Actively Recruiting

2

Justus-Liebig-University Giessen

Giessen, Germany

Actively Recruiting

3

Hannover Medical School

Hanover, Germany

Actively Recruiting

4

University of Heidelberg

Heidelberg, Germany

Actively Recruiting

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Research Team

S

Simon Y Graeber, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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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 | DecenTrialz