A natural history study of exocrine pancreatic function in infants with CF less than 12 months of age
Details
- Therapeutic approach
- Observational
- Trial status
- Recruitment complete Participating Centres
- Trials Tracker ID
- TT014386
- Last updated
- 04/10/2024
Full title
A natural history study of exocrine pancreatic function in infants with CF less than 12 months of age who are not treated with a CFTR modulator like Kaftrio
Study detailsThis study is being done to learn more about the pancreas (an organ that helps digest food) and the intestines in infants with CF who are not treated with a Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulator. A CFTR modulator is a medication that works to correct the protein that is affected in CF.
Participants in the study will provide stool samples which will give information about how the infants' digestive system (including the pancreas) is working, and how that may change over time. This information may inform the design and interpretation of future studies of CFTR modulator treatment during the first year of life.
- Phase
- Not applicable
- Length of participation
- Up to 52 weeks
- Recruitment target
- 15
- CF sponsor
- Vertex
- CF sponsor type
- Commercial
Who can take part?
- Age range
- Up to 12 months
- Including people
- Infants with CF, less than 6 months of age at time of entry into the study
- Not receiving Kaftrio or any other cystic fibrosis transmembrane conductance regulator gene (CFTR) modulator
- Excluding people
- Participant whose mother took any CFTR modulator while pregnant with the participant, or who has any history of exposure to a CFTR modulator
- Remote participation
- Remote participation is possible for this trial