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NCT03350828 Clinical Trial

CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes

Cystic Fibrosis Clinical Trial

— CHEC-SC  

Official title:
The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03350828
Other study ID # CHEC-OB-17
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 15, 2018
Est. completion date December 31, 2024

Study information
Verified date November 2023
Source Seattle Children's Hospital
Contact Olena Boyarska
Email olena.boyarska@seattlechildrens.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies.

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 SC at their local site laboratory. Limited clinical data obtained at this visit will be augmented by retrospective and prospective data obtained from the Cystic Fibrosis Foundation Patient Registry (CFFPR). Study subjects who have been prescribed and switch to an alternative commercially approved CFTR modulator will be approached to re-enroll in the study after being on the alternative modulator for at least 3 months so that a new SC value can be obtained.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 4 Months and older
Eligibility Inclusion Criteria: 1. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative 2. Enrolled in the CFFPR 3. Male or female = 4 months of age on day of study visit 4. Diagnosis of CF. 5. Current treatment with a prescribed commercially approved CFTR modulator for at least 90 days prior to enrollment 6. Able to perform the testing and procedures required for this study, as judged by the investigator Additional Inclusion Criteria for CHEC-PKPD Sub-Study: 1. Male or female = 6 years of age on day of study visit. 2. Current treatment with elexacaftor/tezacaftor/ivacaftor for at least 90 days prior to enrollment. 3. 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 Criteria: 1. 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 2. 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital Medical Center of Akron Akron Ohio
United States University of Michigan, Michigan Medicine Ann Arbor Michigan
United States Children's Healthcare of Atlanta and Emory University Atlanta Georgia
United States Emory University Atlanta Georgia
United States Children's Hospital Colorado Aurora Colorado
United States John Hopkins Hospital Baltimore Maryland
United States The Children's Hospital Alabama, University of Alabama at Birmingham Birmingham Alabama
United States Boston Children's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States The Cystic Fibrosis Center of Western New York Buffalo New York
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States University of Chicago Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center Cleveland Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States University of Texas Southwestern / Children's Health Dallas Texas
United States University of Texas Southwestern Medical Center Dallas Texas
United States National Jewish Health Denver Colorado
United States Children's Hospital of Michigan Detroit Michigan
United States University of Florida Gainesville Florida
United States Helen DeVos Children's Hospital Grand Rapids Michigan
United States Hershey Medical Center Pennsylvania State University Hershey Pennsylvania
United States Baylor College of Medicine Houston Texas
United States Riley Hospital for Children Indianapolis Indiana
United States Children's Mercy Kansas City Kansas City Missouri
United States University of Kansas Medical Center Kansas City Kansas
United States University of California San Diego La Jolla California
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States University of Kentucky Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Childrens Hospital Los Angeles Los Angeles California
United States University of Wisconsin Madison Wisconsin
United States University of Tennessee CF Care and Research Center Memphis Tennessee
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States The Minnesota Cystic Fibrosis Center Minneapolis Minnesota
United States West Virginia University - Morgantown Morgantown West Virginia
United States Vanderbilt Children's Hospital Nashville Tennessee
United States Yale University School of Medicine New Haven Connecticut
United States The Nemours Children's Clinic - Orlando Orlando Florida
United States Nemours Children's Clinic - Pensacola Pensacola Florida
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania
United States Oregon Health Sciences University Portland Oregon
United States SSM Health Cardinal Glennon Children's Hospital Saint Louis Missouri
United States St. Louis Children's Hospital Saint Louis Missouri
United States Primary Children's Cystic Fibrosis Center Salt Lake City Utah
United States Seattle Children's Hospital Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Toledo Children's Hospital Toledo Ohio
United States New York Medical College at Westchester Medical Center Valhalla New York

Sponsors (2)
Lead Sponsor Collaborator
Nicole Hamblett Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary mean change in sweat chloride pre- to post- modulator therapy mean change in sweat chloride pre- to post- modulator therapy through study completion, an average of 1 year
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