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NCT06506773Completed

Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis (CF)

A Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis Less Than 12 Months of Age

Source: ClinicalTrials.gov · Last updated 31 Dec 2025

Brief summary (registry, in English)

The purpose of the study is to evaluate the natural history of exocrine pancreatic function by assessing Fecal elastase-1 (FE-1) in infants with CF during their first year of life.

Status (registry)
Completed
Study type
Observational
Enrollment
79 (actual)
First submitted
27 Jun 2024
Start date
Jul 2024
Primary completion date
Nov 2025
Lead sponsor
Vertex Pharmaceuticals Incorporated
NCT number
NCT06506773

What you commit to

  • Study type: Observational
  • Participants enrolled: 79
  • From Jul 2024 to the primary completion date, Nov 2025
  • 50 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Participant whose mother took any CFTR modulator while pregnant with the participant, or who has any history of exposure to a CFTR modulator
    • Other protocol defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • Participants with CF less than (\<) 6 months of age at the index date
  • 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

Age in the registry: - to 6 months · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Kids Research Institute Australia
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
Women's and Children's Hospital
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North AdelaideAustraliaUnknown status
Queensland Children's Hospital
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South BrisbaneAustraliaUnknown status
McGill University Health Centre, Glen Site, Montreal Children's Hospital
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MontrealCanadaUnknown status
Centre hospitalier de Quebec, Université Laval
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QuébecCanadaUnknown status
The Hospital for Sick Children
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TorontoCanadaUnknown status
British Columbia Children's Hospital
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VancouverCanadaUnknown status
Kinderspital Zürich
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ZurichSwitzerlandUnknown status
Fakultni nemocnice v Motole
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PragueCzechiaUnknown status
Charité - Paediatric Pulmonology Department
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Kinderklinik III, Abt. fur Pneumologie
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Klinikum Westbrandenburg (CF)
Coordinator of this site? Confirm its status
PotsdamGermanyUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
University Hospitals Bristol and Weston NHS Foundation Trust Bristol Royal Hospital for Children
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BristolUnited KingdomUnknown status
Royal Hospital for Children
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GlasgowUnited KingdomUnknown status
Leeds Regional Children's Cystic Fibrosis Centre
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LeedsUnited KingdomUnknown status
Leicester Royal Infirmary, University of Leicester
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LeicesterUnited KingdomUnknown status
The Royal London Children's Hospital
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LondonUnited KingdomUnknown status
Great Ormond Street Hospital for Children
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LondonUnited KingdomUnknown status
Royal Manchester Children's Hospital
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ManchesterUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust, Children's Clinical Research Facility
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NottinghamUnited KingdomUnknown status
Royal Stoke University Hospital
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Stoke-on-TrentUnited KingdomUnknown status
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
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FlorenceItalyUnknown status
Canterbury District Health Board
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ChristchurchNew ZealandUnknown status
Starship Children's Hospital
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GraftonNew ZealandUnknown status
Pediatric Hospital Polanki named of Maciej Płażyński
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GdanskPolandUnknown status
Akron Children's Hospital
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AkronUnited StatesUnknown status
Michigan Medicine
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Ann ArborUnited StatesUnknown status
Billings Clinic
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BillingsUnited StatesUnknown status
St. Luke's Cystic Fibrosis Center of Idaho
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BoiseUnited StatesUnknown status
Boston Childrens Hospital
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BostonUnited StatesUnknown status
Ann & Robert H. Lurie Children's Hospital of Chicago
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ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center
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ClevelandUnited StatesUnknown status
Prisma Health Clinical Research Unit - Midlands
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ColumbiaUnited StatesUnknown status
Dayton Children's Hospital
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DaytonUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Riley Hospital for Children at Indiana University Health
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IndianapolisUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
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MinneapolisUnited StatesUnknown status
West Virginia University
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MorgantownUnited StatesUnknown status
Children's Nebraska
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OmahaUnited StatesUnknown status
Virginia Commonwealth University Hospital Systems, Children's Pavilion
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RichmondUnited StatesUnknown status
Sanford Children's Speciality Clinic
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Sioux FallsUnited StatesUnknown status
Providence Pediatric Pulmonary & Cystic Fibrosis Clinic
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SpokaneUnited StatesUnknown status
Johns Hopkins All Children's Hospital Outpatient Care Center
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St. PetersburgUnited StatesUnknown status
ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center
Coordinator of this site? Confirm its status
ToledoUnited StatesUnknown status
The University of Texas Health Science Center at Tyler
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TylerUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.