Exocrine pancreatic insufficiency (EPI)
Conditions
Interventions
None listed
Sponsors
Vertex Pharmaceuticals
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1. Participant*s legally appointed and authorized representative (e.g., parent or legal guardian) will sign and date an informed consent form (ICF). 2. Male or female participants with CF
Exclusion criteria
Exclusion criteria: 1. History of any illness or any clinical condition that, in the opinion of the investigator, might either confound the results of the study or impact participant*s ability to participate. 2. Ongoing or any prior participation in an investigational drug study. Note: Ongoing participation in a noninterventional study (including observational studies) is permitted. 3. Participant whose mother took any CFTR modulator while pregnant with the participant, or who has any history of exposure to a CFTR modulator (e.g., through consumption of breast milk from a mother on a CFTR modulator or other means). 4. A close relative of the participant is the investigator or a subinvestigator, research assistant, study coordinator, or other staff directly involved with the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with FE-1 >=200 µg/g over time | — |
Secondary
| Measure | Time frame |
|---|---|
| FE-1 level over time | — |
Countries
Netherlands
Outcome results
None listed