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
| NCT ID | NCT04732910 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Cystic Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2018-07-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2018-07-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (ICM), nasal potential difference (NPD) and sweat chloride in a post-approval setting in patients with cystic fibrosis (CF).
Eligibility Criteria
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)
Contact & Investigator
Marcus A Mall, MD
PRINCIPAL INVESTIGATOR
Charite University, Berlin, Germany
Frequently Asked Questions
Who can join the NCT04732910 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04732910 currently recruiting?
Yes, NCT04732910 is actively recruiting participants. Contact the research team at simon.graeber@charite.de for enrollment information.
Where is the NCT04732910 trial being conducted?
This trial is being conducted at Berlin, Germany, Giessen, Germany, Hanover, Germany, Heidelberg, Germany.
Who is sponsoring the NCT04732910 clinical trial?
NCT04732910 is sponsored by Charite University, Berlin, Germany. The principal investigator is Marcus A Mall, MD at Charite University, Berlin, Germany. The trial plans to enroll 500 participants.