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
- Diseases
- Cystic fibrosis
- 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
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Kids Research Institute Australia Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Women's and Children's Hospital Coordinator of this site? Confirm its status | North Adelaide | Australia | Unknown status |
| Queensland Children's Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| McGill University Health Centre, Glen Site, Montreal Children's Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre hospitalier de Quebec, Université Laval Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| British Columbia Children's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Kinderspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Charité - Paediatric Pulmonology Department Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Kinderklinik III, Abt. fur Pneumologie Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Klinikum Westbrandenburg (CF) Coordinator of this site? Confirm its status | Potsdam | Germany | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| University Hospitals Bristol and Weston NHS Foundation Trust Bristol Royal Hospital for Children Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Royal Hospital for Children Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Leeds Regional Children's Cystic Fibrosis Centre Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Leicester Royal Infirmary, University of Leicester Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| The Royal London Children's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Great Ormond Street Hospital for Children Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Manchester Children's Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust, Children's Clinical Research Facility Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Royal Stoke University Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
| Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Canterbury District Health Board Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Starship Children's Hospital Coordinator of this site? Confirm its status | Grafton | New Zealand | Unknown status |
| Pediatric Hospital Polanki named of Maciej Płażyński Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Akron Children's Hospital Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Michigan Medicine Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Billings Clinic Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| St. Luke's Cystic Fibrosis Center of Idaho Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Boston Childrens Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Prisma Health Clinical Research Unit - Midlands Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Dayton Children's Hospital Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Riley Hospital for Children at Indiana University Health Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Children's Nebraska Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Virginia Commonwealth University Hospital Systems, Children's Pavilion Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Sanford Children's Speciality Clinic Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Providence Pediatric Pulmonary & Cystic Fibrosis Clinic Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Johns Hopkins All Children's Hospital Outpatient Care Center Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| The University of Texas Health Science Center at Tyler Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.