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Trial record 1 of 1 for:    NCT03350828
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CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes (CHEC-SC)

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ClinicalTrials.gov Identifier: NCT03350828
Recruitment Status : Active, not recruiting
First Posted : November 22, 2017
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Nicole Hamblett, Seattle Children's Hospital

Tracking Information
First Submitted Date November 9, 2017
First Posted Date November 22, 2017
Last Update Posted Date June 21, 2022
Actual Study Start Date January 15, 2018
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2017)
mean change in sweat chloride pre- to post- modulator therapy [ Time Frame: through study completion, an average of 1 year ]
mean change in sweat chloride pre- to post- modulator therapy
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
Official Title The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
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 commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies.
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 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cystic Fibrosis Care Centers
Condition Cystic Fibrosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 10, 2019)
5000
Original Estimated Enrollment
 (submitted: November 20, 2017)
1000
Estimated Study Completion Date December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03350828
Other Study ID Numbers CHEC-OB-17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Nicole Hamblett, Seattle Children's Hospital
Original Responsible Party Same as current
Current Study Sponsor Nicole Hamblett
Original Study Sponsor Same as current
Collaborators Cystic Fibrosis Foundation
Investigators
Principal Investigator: Edith Zemanick, MD University of Colorado, Denver
Principal Investigator: Michael Konstan, MD Case Western Reserve University
Principal Investigator: Nicole Mayer-Hamblett, PhD Seattle Children's Hospital
PRS Account Seattle Children's Hospital
Verification Date June 2022