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NCT06683092 · ClinicalTrials.gov registry record
Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL)
A clinical trial of Cystic Fibrosis, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- 200
- Enrollment target
- 18
- Study locations
NCT06683092: Recruiting study of Cystic Fibrosis, sponsored by Boston Children's Hospital.
NCT06683092 is a study of Cystic Fibrosis that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 200 participants, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (12% higher). The trial reports 18 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06683092, a study of Cystic Fibrosis, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 18
- Study locations
Study Summary
RETRIAL is a multi-site observational study of people with Cystic Fibrosis (PWCF) ages 6 and up starting the new triple-therapy modulator (vanzacaftor/tezacaftor/deutivacaftor (VTD)), after having experienced neuropsychiatric events and/or liver injury while taking elexacaftor/tezacaftor/ivacaftor (ETI) that resulted in a modification or discontinuation of standard ETI dosing.
Primary Outcome
Discontinuation or change from VTD standard dosing due to mental health symptoms at any time during the one-year follow-up as reported in either: daily diaries, biweekly or quarterly surveys, or chart review.
Conditions Studied
Interventions
- OTHER RETRIAL-Mental Health
- OTHER RETRIAL-Liver
- OTHER RETRIAL-Neuro
Study Locations (18)
Florida
- Nemours Children's - Jacksonville
- Nemours Children's - Orlando
- Nemours Children's - Pensacola
Colorado
- Children's Hospital Colorado - Aurora
- National Jewish Health - Denver
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Children's Hospital - Boston
Alabama
- University of Alabama at Birmingham - Birmingham
Delaware
- Nemours Children's - Wilmington
Georgia
- Emory University - Atlanta
Indiana
- Indiana University - Bloomington
Kansas
- Kansas University Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-05-01 |
| Est. Completion | 2028-06 |
What NCT06683092 shows while recruiting
NCT06683092 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (12% higher).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 3 interventions - of which RETRIAL-Mental Health is the first listed.
NCT06683092 lists 18 locations in 14 states (Florida, Colorado, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06683092 about?
NCT06683092 is a clinical study titled "Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL)". RETRIAL is a multi-site observational study of people with Cystic Fibrosis (PWCF) ages 6 and up starting the new triple-therapy modulator (vanzacaftor/tezacaftor/deutivacaftor (VTD)), after having experienced neuropsychiatric events and/or liver injury while taking elexacaftor/tezacaftor/ivacaftor (...
What is the current status of trial NCT06683092?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2025-05-01. Estimated completion is 2028-06.
What conditions does trial NCT06683092 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT06683092?
The interventions under investigation include: RETRIAL-Mental Health (OTHER), RETRIAL-Liver (OTHER), RETRIAL-Neuro (OTHER).
Who is sponsoring clinical trial NCT06683092?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06683092 being conducted?
This trial has 18 study locations across Alabama, Colorado, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06683092's enrollment target sits among peer trials
200 36th of 169 higher than 134 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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