Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis (CF)
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT06506773
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 79
- Participants with CF less than (<) 6 months of age at the index date
- Participants not eligible to receive commercial Kalydecoโข (based on local product labels) and are not receiving Kalydeco or any other cystic fibrosis transmembrane conductance regulator gene (CFTR) modulator
Key
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of Participants with FE-1 greater than or equal to (โฅ) 200 microgram per gram (ยตg/g) Over Time From Enrollment up to the Infant turning 12 Months of Age
- Secondary Outcome Measures
Name Time Method FE-1 level Over Time From Enrollment up to the Infant turning 12 Months of Age
Trial Locations
- Locations (50)
Fakultni nemocnice v Motole
๐จ๐ฟPraha 5, Czechia
Charite Paediatric Pulmonology Department
๐ฉ๐ชBerlin, Germany
Kinderklinik III, Abt. fur Pneumologie
๐ฉ๐ชEssen, Germany
Klinikum Westbrandenburg (CF)
๐ฉ๐ชPotsdam, Germany
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
๐ฎ๐นFirenze, Italy
Duke University Medical Center
๐บ๐ธDurham, North Carolina, United States
Akron Children's Hospital
๐บ๐ธAkron, Ohio, United States
Cincinnati Children's Hospital Medical Center
๐บ๐ธCincinnati, Ohio, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
๐บ๐ธCleveland, Ohio, United States
Dayton Children's Hospital
๐บ๐ธDayton, Ohio, United States
ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center
๐บ๐ธToledo, Ohio, United States
Johns Hopkins All Children's Hospital Outpatient Care Center
๐บ๐ธSaint Petersburg, Florida, United States
St. Luke's Cystic Fibrosis Center of Idaho
๐บ๐ธBoise, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
๐บ๐ธChicago, Illinois, United States
Riley Hospital for Children at Indiana University Health
๐บ๐ธIndianapolis, Indiana, United States
Boston Childrens Hospital
๐บ๐ธBoston, Massachusetts, United States
Michigan Medicine
๐บ๐ธAnn Arbor, Michigan, United States
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
๐บ๐ธMinneapolis, Minnesota, United States
Billings Clinic
๐บ๐ธBillings, Montana, United States
Prisma Health Clinical Research Unit - Midlands
๐บ๐ธColumbia, South Carolina, United States
Children's Nebraska
๐บ๐ธOmaha, Nebraska, United States
Sanford Children's Speciality Clinic
๐บ๐ธSioux Falls, South Dakota, United States
British Columbia Children's Hospital
๐จ๐ฆVancouver, Canada
The University of Texas Health Science Center at Tyler
๐บ๐ธTyler, Texas, United States
Virginia Commonwealth University Hospital Systems, Children's Pavilion
๐บ๐ธRichmond, Virginia, United States
Providence Pediatric Pulmonary & Cystic Fibrosis Clinic
๐บ๐ธSpokane, Washington, United States
West Virginia University
๐บ๐ธMorgantown, West Virginia, United States
Medical College of Wisconsin
๐บ๐ธMilwaukee, Wisconsin, United States
The Kids Research Institute Australia
๐ฆ๐บNedlands, Australia
Women's and Children's Hospital
๐ฆ๐บNorth Adelaide, Australia
Queensland Children's Hospital
๐ฆ๐บSouth Brisbane, Australia
McGill University Health Centre, Glen Site, Montreal Children's Hospital
๐จ๐ฆMontreal, Canada
Centre Hospitalier de Quebec - Universite Laval
๐จ๐ฆQuebec City, Canada
The Hospital for Sick Children
๐จ๐ฆToronto, Canada
Canterbury District Health Board
๐ณ๐ฟChristchurch, New Zealand
Starship Children's Hospital
๐ณ๐ฟGrafton, New Zealand
Pediatric Hospital Polanki named of Maciej Pลaลผyลski
๐ต๐ฑGdaลsk, Poland
Hospital Universitario 12 de Octubre
๐ช๐ธMadrid, Spain
Hospital Universitario Ramon y Cajal
๐ช๐ธMadrid, Spain
Hospital Universitario Virgen del Rocio
๐ช๐ธSevilla, Spain
Kinderspital Zurich
๐จ๐ญZurich, Switzerland
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital for Children
๐ฌ๐งBristol, United Kingdom
Royal Hospital for Children
๐ฌ๐งGlasgow, United Kingdom
Leeds Regional Children's Cystic Fibrosis Centre
๐ฌ๐งLeeds, United Kingdom
Leicester Royal Infirmary, University of Leicester
๐ฌ๐งLeicester, United Kingdom
Great Ormond Street Hospital for Children
๐ฌ๐งLondon, United Kingdom
The Royal London Children's Hospital
๐ฌ๐งLondon, United Kingdom
Royal Manchester Children's Hospital
๐ฌ๐งManchester, United Kingdom
Nottingham University Hospitals NHS Trust, Children's Clinical Research Facility
๐ฌ๐งNottingham, United Kingdom
Royal Stoke University Hospital
๐ฌ๐งStoke on Trent, United Kingdom