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 Kalydeco™ (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 (≥) 200 microgram per gram (µg/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)
Johns Hopkins All Children's Hospital Outpatient Care Center
🇺🇸Saint 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
Scroll for more (40 remaining)Johns Hopkins All Children's Hospital Outpatient Care Center🇺🇸Saint Petersburg, Florida, United States