Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis (CF)
NCT ID: NCT06506773
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
79 participants
OBSERVATIONAL
2024-07-09
2025-11-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A
Observational follow-up study to characterize the natural history of exocrine pancreatic function by measuring FE-1 in infants with CF.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants not eligible to receive commercial Kalydeco™ (based on local product labels) and are not receiving Kalydeco or any other cystic fibrosis transmembrane conductance regulator gene (CFTR) modulator
Exclusion Criteria
6 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Johns Hopkins All Children's Hospital Outpatient Care Center
St. Petersburg, Florida, United States
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Boston Childrens Hospital
Boston, Massachusetts, United States
Michigan Medicine
Ann Arbor, Michigan, United States
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
Billings Clinic
Billings, Montana, United States
Children's Nebraska
Omaha, Nebraska, United States
Duke University Medical Center
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, 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
Dayton Children's Hospital
Dayton, Ohio, United States
ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center
Toledo, Ohio, United States
Prisma Health Clinical Research Unit - Midlands
Columbia, South Carolina, United States
Sanford Children's Speciality Clinic
Sioux Falls, South Dakota, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States
Virginia Commonwealth University Hospital Systems, Children's Pavilion
Richmond, Virginia, United States
Providence Pediatric Pulmonary & Cystic Fibrosis Clinic
Spokane, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
The Kids Research Institute Australia
Nedlands, , Australia
Women's and Children's Hospital
North Adelaide, , Australia
Queensland Children's Hospital
South Brisbane, , Australia
McGill University Health Centre, Glen Site, Montreal Children's Hospital
Montreal, , Canada
Centre Hospitalier de Quebec - Universite Laval
Québec, , Canada
The Hospital for Sick Children
Toronto, , Canada
British Columbia Children's Hospital
Vancouver, , Canada
Fakultni nemocnice v Motole
Prague, , Czechia
Charite Paediatric Pulmonology Department
Berlin, , Germany
Kinderklinik III, Abt. fur Pneumologie
Essen, , Germany
Klinikum Westbrandenburg (CF)
Potsdam, , Germany
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, , Italy
Canterbury District Health Board
Christchurch, , New Zealand
Starship Children's Hospital
Grafton, , New Zealand
Pediatric Hospital Polanki named of Maciej Płażyński
Gdansk, , Poland
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Kinderspital Zurich
Zurich, , Switzerland
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital for Children
Bristol, , United Kingdom
Royal Hospital for Children
Glasgow, , United Kingdom
Leeds Regional Children's Cystic Fibrosis Centre
Leeds, , United Kingdom
Leicester Royal Infirmary, University of Leicester
Leicester, , United Kingdom
Great Ormond Street Hospital for Children
London, , United Kingdom
The Royal London Children's Hospital
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust, Children's Clinical Research Facility
Nottingham, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VX24-445-130
Identifier Type: -
Identifier Source: org_study_id