Status:
ACTIVE_NOT_RECRUITING
CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
Lead Sponsor:
Nicole Hamblett
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
4+ years
Brief Summary
This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving...
Detailed Description
Eligible subjects who have been prescribed and chronically taking a commercially approved CFTR modulator for at least 3 months will be enrolled for a single visit to collect sweat to be analyzed for S...
Eligibility Criteria
Inclusion
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
- Enrolled in the CFFPR
- Male or female ≥ 4 months of age on day of study visit
- Diagnosis of CF.
- Current treatment with a prescribed commercially approved CFTR modulator for at least 90 days prior to enrollment
- Able to perform the testing and procedures required for this study, as judged by the investigator
- Additional Inclusion Criteria for CHEC-PKPD Sub-Study:
- Male or female ≥ 6 years of age on day of study visit.
- Current treatment with elexacaftor/tezacaftor/ivacaftor for at least 90 days prior to enrollment.
- Last dose of elexacaftor/tezacaftor/ivacaftor taken at least 24hours and last dose of ivacaftor taken at least 12 hours prior to trough blood draw on day of visit.
Exclusion
- Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
- Currently enrolled in an investigational trial (including open-label follow-on studies and Early Access Programs (EAP) of an agent expected to have an impact on sweat chloride (refer to current list provided on study website)
Key Trial Info
Start Date :
January 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT03350828
Start Date
January 15 2018
End Date
December 31 2026
Last Update
October 10 2025
Active Locations (52)
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1
The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
University of California San Diego
La Jolla, California, United States, 92093
4
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027