๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-10-30

Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL) (NCT06683092)

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Boston Children's Hospital

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 6 Years

๐Ÿงช Interventions in This Study

  • RETRIAL-Mental Health (OTHER)
  • RETRIAL-Liver (OTHER)
  • RETRIAL-Neuro (OTHER)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (18 Sites)

  • University of Alabama at Birmingham โ€” Birmingham, Alabama
  • Children's Hospital Colorado โ€” Aurora, Colorado
  • National Jewish Health โ€” Denver, Colorado
  • Nemours Children's โ€” Wilmington, Delaware
  • Nemours Children's โ€” Jacksonville, Florida
  • Nemours Children's โ€” Orlando, Florida
  • Nemours Children's โ€” Pensacola, Florida
  • Emory University โ€” Atlanta, Georgia
  • Indiana University โ€” Bloomington, Indiana
  • Kansas University Medical Center โ€” Kansas City, Kansas
  • Johns Hopkins University โ€” Baltimore, Maryland
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Boston Children's Hospital โ€” Boston, Massachusetts
  • University of Michigan โ€” Ann Arbor, Michigan
  • Washington University at St. Louis โ€” St Louis, Missouri
  • University of Pittsburgh Medical Center โ€” Pittsburgh, Pennsylvania
  • University of Texas Southwestern Medical Center โ€” Dallas, Texas
  • Seattle Children's Hospital โ€” Seattle, Washington

๐Ÿ“ž Contact the Study Coordinator

Phone: (617) 919-6154

Email: evelyn.bord@childrens.harvard.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Cystic Fibrosis clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—