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

Last updated: August 15, 2024
Sponsor: Nicole Hamblett
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cystic Fibrosis

Scar Tissue

Lung Disease

Treatment

N/A

Clinical Study ID

NCT03350828
CHEC-OB-17
  • Ages > 4
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent (and assent when applicable) obtained from subject orsubject'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 atleast 90 days prior to enrollment

  6. Able to perform the testing and procedures required for this study, as judged by theinvestigator

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 priorto enrollment.

  3. Last dose of elexacaftor/tezacaftor/ivacaftor taken at least 24hours and last doseof ivacaftor taken at least 12 hours prior to trough blood draw on day of visit.

Exclusion

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-onstudies and Early Access Programs (EAP) of an agent expected to have an impact onsweat chloride (refer to current list provided on study website)

Study Design

Total Participants: 5000
Study Start date:
January 15, 2018
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • The Children's Hospital Alabama, University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • Childrens Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • The Nemours Children's Clinic - Orlando

    Orlando, Florida 32827
    United States

    Site Not Available

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida 32514
    United States

    Site Not Available

  • Children's Healthcare of Atlanta and Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30327
    United States

    Site Not Available

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • John Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan, Michigan Medicine

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Children's Hospital of Michigan

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • The Minnesota Cystic Fibrosis Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Children's Mercy Kansas City

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • SSM Health Cardinal Glennon Children's Hospital

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • St. Louis Children's Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • The Cystic Fibrosis Center of Western New York

    Buffalo, New York 14203
    United States

    Site Not Available

  • New York Medical College at Westchester Medical Center

    Valhalla, New York 10595
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • Children's Hospital Medical Center of Akron

    Akron, Ohio 44308
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Toledo Children's Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Oregon Health Sciences University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Hershey Medical Center Pennsylvania State University

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • University of Tennessee CF Care and Research Center

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Vanderbilt Children's Hospital

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Texas Southwestern / Children's Health

    Dallas, Texas 75207
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Primary Children's Cystic Fibrosis Center

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • West Virginia University - Morgantown

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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