Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL)
NCT ID: NCT06683092
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-05-01
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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RETRIAL-Mental Health
People with CF ages 6 and up with a history of new or worsening mental health symptoms (such as depression, anxiety, mood, sleep) while on elexacaftor/tezacaftor/ivacaftor (ETI) requiring discontinuation or change from standard dosing who start taking vanzacaftor/tezacaftor/deutivacaftor (VTD).
RETRIAL-Mental Health
Participants will complete: daily diaries for 6 weeks, from about 2 weeks prior to starting VTD to about 4 weeks after; biweekly surveys, from about 2 weeks prior to starting VTD to 6 months after, and 2 quarterly surveys (at 9mo and 12mo post-initiation of VTD).
RETRIAL-Neuro
People with CF from RETRIAL-Mental Health who experienced new/worsening neurocognitive symptoms (such as brain fog or memory problems) while taking elexacaftor/tezacaftor/ivacaftor (ETI).
RETRIAL-Neuro
Participants will complete a neurocognitive assessment prior to starting VTD and 28 days after.
RETRIAL-Liver
People with Cystic Fibrosis ages 6 and up with a history of drug-induced liver injury (such as elevated liver enzymes) attributed to elexacaftor/tezacaftor/ivacaftor (ETI) requiring dose modification or discontinuation who start taking vanzacaftor/tezacaftor/deutivacaftor (VTD).
RETRIAL-Liver
Participants may have a research liver function test done prior to starting VTD and 28 days after, if not done clinically.
Participants will complete surveys: before starting VTD, a month after, and quarterly (at about 3, 6, 9, and 12 months) following VTD initiation.
Interventions
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RETRIAL-Mental Health
Participants will complete: daily diaries for 6 weeks, from about 2 weeks prior to starting VTD to about 4 weeks after; biweekly surveys, from about 2 weeks prior to starting VTD to 6 months after, and 2 quarterly surveys (at 9mo and 12mo post-initiation of VTD).
RETRIAL-Liver
Participants may have a research liver function test done prior to starting VTD and 28 days after, if not done clinically.
Participants will complete surveys: before starting VTD, a month after, and quarterly (at about 3, 6, 9, and 12 months) following VTD initiation.
RETRIAL-Neuro
Participants will complete a neurocognitive assessment prior to starting VTD and 28 days after.
Eligibility Criteria
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Inclusion Criteria
* Eligible for VTD and intending to take it
* Experienced new or worsening mental health symptoms after initiating ETI, which led to one of the following changes in treatment to currently taking:
1. No modulators
2. A modulator other than ETI
3. A flipped dose of ETI
4. A reduced dose of ETI
* Willing to delay first VTD dose for short period of time to complete the Baseline assessments
* Has access to a smart device (phone, tablet, etc.) capable of receiving messages with survey links
* Is English-speaking.
RETRIAL-LIVER:
* A person with CF age 6 years and up
* Eligible for VTD and intending to take it
* Experienced drug-induced liver injury (as defined by local care team) after initiating ETI, which led to one of the following changes in treatment to currently taking:
1. no modulators; or
2. a modulator other than ETI; or
3. a reduced or altered dose of ETI;
* Willing to delay first VTD dose for short period of time to complete the Baseline assessments
* Has access to a smart device (phone, tablet, etc.) capable of receiving messages with survey links
* Is English-speaking.
* Is a primary, daily caregiver of a person with CF under the age of 12 enrolled in the study
* Has access to smart device (phone, tablet, etc.) capable of receiving messages with survey links
* Is able to read and complete surveys and Daily Diary in English.
Exclusion Criteria
* Cannot access VTD
* Currently, or prior history of, taking VTD
* Unable or unwilling to follow protocol
* If \<12 years old, having another \<12-year-old person in the same household consented into the study
* Is actively listed on any transplant list, or within 3 months post-transplant surgery
* Is currently pregnant (test not required)
* Anticipated change in CF Care Centers in the next 6 months
* Any situation that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
RETRIAL-LIVER:
* Cannot access VTD
* Currently, or prior history of, taking VTD
* Unable or unwilling to follow protocol
* If \<12 years old, having another \<12-year-old person in the same household consented into the study
* Any severe, decompensated liver disease (e.g. Child-Pugh, Class C)
* Is actively listed on any transplant list, or within 3 months post-transplant surgery (any organ), or history of liver transplant
* Is currently pregnant (test not required)
* Anticipated change in CF Care Centers in the next 6 months
* Any situation that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
Caregiver Participant:
\- Any situation that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
6 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
Johns Hopkins University
OTHER
Massachusetts General Hospital
OTHER
National Jewish Health
OTHER
Indiana University
OTHER
Children's Hospital Colorado
OTHER
University of Kansas Medical Center
OTHER
Washington University School of Medicine
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Gregory Sawicki
Co-Chair of Success with Therapies Research Consortium
Principal Investigators
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Anna Georgiopoulos, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
CJ Bathgate, PhD
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health
Janis Stoll, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University at St. Louis
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Children's Hospital Colorado
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Nemours Children's
Wilmington, Delaware, United States
Nemours Children's
Jacksonville, Florida, United States
Nemours Children's
Orlando, Florida, United States
Nemours Children's
Pensacola, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Bloomington, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University at St. Louis
St Louis, Missouri, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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James Fowler
Role: backup
Eric Hunter
Role: backup
Mary Heskett
Role: backup
Ruobin Wei
Role: primary
Jessica Carey
Role: backup
Stacy Postma
Role: primary
Other Identifiers
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IRB-P00050262
Identifier Type: -
Identifier Source: org_study_id
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