Phase 4 Cystic Fibrosis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You (or your child's legal guardian) must be willing and able to give written permission to take part in the study.
• You must be willing to attend all scheduled study visits and follow the study's requirements.
• The child must be between 6 and 8 years old at the time of the MRI visit (they may be enrolled up to 60 days before their 6th birthday).
• The child must have a confirmed diagnosis of cystic fibrosis (CF), shown either by a sweat test result of 60 or above, or by having two known CF gene changes.
• The child's doctor must be planning to prescribe a triple-combination CF medication.
• The child must be in a stable health condition with no current respiratory (breathing) infection at the time of joining the study.
• There must have been no changes to the child's regular ongoing medications in the 28 days before joining.
• The child must be able to stay still and cooperate during an MRI scan.

Who may not be able to join:

• Children who are currently taking ivacaftor-based treatments (such as Kalydeco, Orkambi, or Symdeko) and also have a specific type of CF gene change called a "gating mutation" (confirm with trial site).
• Children who have active breathing symptoms, such as wheezing, at the time of the MRI.
• Children who have had a breathing infection — shown by increased coughing, wheezing, or faster breathing — in the 28 days before joining.
• Children who have a chronic lung condition that is not caused by CF.
• Children who have a chronic liver condition that is not caused by CF.
• Children who are currently experiencing an episode of acute pancreatitis (a sudden, painful inflammation of the pancreas).
• Children who have a long-term pancreas condition that is not caused by CF.
• Children who have any physical findings that could affect their safety or the quality of the study results, as decided by the study doctor.
• Children who have any other condition that, in the study doctor's opinion, could make participation unsafe, affect the study results, or prevent proper consent from being given.

Important: Always verify eligibility with the trial site directly before applying.