Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis (CF)

A Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis Less Than 12 Months of Age

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06506773

Enrollment

Registered

2024-07-17

Start date

2024-07-09

Completion date

2025-11-27

Last updated

2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * 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 criteria

* 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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
FE-1 level Over Time	From Enrollment up to the Infant turning 12 Months of Age

Countries

Australia, Canada, Czechia, Germany, Italy, New Zealand, Poland, Spain, Switzerland, United Kingdom, United States

Outcome results