Status:
COMPLETED
Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis (CF)
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
Up to 6 years
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.
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 27 2025
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT06506773
Start Date
July 9 2024
End Date
November 27 2025
Last Update
December 31 2025
Active Locations (50)
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1
Johns Hopkins All Children's Hospital Outpatient Care Center
St. Petersburg, Florida, United States, 33701
2
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States, 83702
3
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
4
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202