Status:
RECRUITING
Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulators
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Hannover Medical School
Heidelberg University
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Brief 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 (...
Detailed Description
Cystic fibrosis transmembrane regulator (CFTR) biomarker (intestinal current measurement (ICM), nasal potential difference (NPD), sweat chloride) before the start of therapy and 12 and 52 weeks after ...
Eligibility Criteria
Inclusion
- 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
- Ongoing participation in an investigational drug study (including studies investigating lumacaftor, tezacaftor or ivacaftor)
Key Trial Info
Start Date :
July 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04732910
Start Date
July 1 2018
End Date
December 31 2027
Last Update
March 4 2024
Active Locations (4)
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1
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
2
Justus-Liebig-University Giessen
Giessen, Germany
3
Hannover Medical School
Hanover, Germany
4
University of Heidelberg
Heidelberg, Germany