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Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL)

NCT06683092 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-11-03

No results posted yet for this 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.

Conditions

Interventions

OTHER

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).

OTHER

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.

OTHER

RETRIAL-Neuro

Participants will complete a neurocognitive assessment prior to starting VTD and 28 days after.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • National Jewish Health

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • Children's Hospital Colorado

    collaborator OTHER

  • University of Kansas Medical Center

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Boston Children's Hospital

    lead OTHER

Principal Investigators

  • Anna Georgiopoulos, MD · Massachusetts General Hospital

  • CJ Bathgate, PhD · National Jewish Health

  • Janis Stoll, MD · Washington University at St. Louis

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2028-03-31
Completion
2028-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06683092 on ClinicalTrials.gov