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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

NCT04732910 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-02-24

No results posted yet for this study

Summary

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

Interventions

DRUG

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

observational

Sponsors & Collaborators

  • Hannover Medical School

    collaborator OTHER

  • Heidelberg University

    collaborator OTHER

  • University of Giessen

    collaborator OTHER

  • University of Luebeck

    collaborator OTHER

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Marcus A Mall, MD · Charite University, Berlin, Germany

  • Simon Y Graeber, MD · Charite University, Berlin, Germany

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2027-03-31
Completion
2027-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732910 on ClinicalTrials.gov