Cystic Fibrosis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For the Mental Health arm of the trial (RETRIAL-Mental Health):
- People with cystic fibrosis (CF) aged 6 years and older (for children under 12, a caregiver will complete the daily diaries and surveys on their behalf)
- People whose doctor has determined they are eligible for the CF treatment called vanzacaftor/tezacaftor/deutivacaftor (VTD) and who are planning to take it
- People who developed new or worsening mental health symptoms after starting the CF treatment ETI, which led to a change — meaning they are currently taking no modulator treatment, a different modulator (not ETI), a "flipped" dose of ETI, or a reduced dose of ETI (confirm with trial site if unsure which category applies)
- People who are willing to wait a short time before taking their first VTD dose, in order to complete the starting assessments
- People who have access to a smartphone, tablet, or similar device that can receive messages with survey links
- People who speak and read English
For the Liver arm of the trial (RETRIAL-LIVER):
- People with CF aged 6 years and older
- People whose doctor has determined they are eligible for VTD and who are planning to take it
- People who experienced liver injury (as determined by their local care team) after starting ETI, which led to a change — meaning they are currently taking no modulator treatment, a different modulator (not ETI), or a reduced or altered dose of ETI
- People who are willing to wait a short time before taking their first VTD dose, in order to complete the starting assessments
- People who have access to a smartphone, tablet, or similar device that can receive messages with survey links
- People who speak and read English
For caregivers (children under 12 only):
- Someone who is the primary, daily caregiver of a child with CF under 12 who is enrolled in the study
- Someone who has access to a smartphone, tablet, or similar device that can receive messages with survey links
- Someone who is able to read and complete surveys and a daily diary in English
Who may not be able to join:
For the Mental Health arm (RETRIAL-Mental Health):
- People for whom VTD is not accessible through their care team
- People who are currently taking VTD or have taken it in the past
- People who are unable or unwilling to follow the study requirements
- Children under 12 where another child under 12 from the same household has already been enrolled in the study
- People who are currently on an active transplant waiting list, or who are within 3 months of having had a transplant
- People who are currently pregnant (no pregnancy test is required to confirm this)
- People who are expecting to change their CF care centre within the next 6 months
- People where the study doctor believes participation could affect their safety or the reliability of the study data
For the Liver arm (RETRIAL-LIVER):
- People for whom VTD is not accessible through their care team
- People who are currently taking VTD or have taken it in the past
- People who are unable or unwilling to follow the study requirements
- Children under 12 where another child under 12 from the same household has already been enrolled in the study
- People with severe, advanced liver disease (for example, Child-Pugh Class C — confirm with trial site)
- People who are currently on a transplant waiting list, within 3 months of any transplant surgery, or who have had a liver transplant in the past
- People who are currently pregnant (no pregnancy test is required to confirm this)
- People who are expecting to change their CF care centre within the next 6 months
- People where the study doctor believes participation could affect their safety or the reliability of the study data
For caregivers:
- People where the study doctor believes their involvement could affect the safety of the patient or the reliability of the study data
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Anna Georgiopoulos, MD, Massachusetts General Hospital
Phone: 617-919-6154
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
RETRIAL-Mental Health (1st objective - discontinuation): one-year incidence of discontinuation or change from VTD standard dosing due to new/worsening mental health symptoms.; RETRIAL-Mental Health (2nd objective - symptoms): proportion of participants that experience any worsening in mental health symptoms during the 6-month follow-up; RETRIAL-Mental Health (3rd objective - RETRIAL-Neuro): proportion of participants that have a worsening on the NIH Toolbox's Fluid Cognition Composite score at 1 month follow-up.; RETRIAL-Liver: one-year incidence of drug-induced liver injury (DILI) with VTD, d...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.