Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL) (NCT06683092)
๐ฉบ 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
๐งช Interventions in This Study
- RETRIAL-Mental Health (OTHER)
- RETRIAL-Liver (OTHER)
- RETRIAL-Neuro (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ 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.
๐ฐ 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.
More studies in Cystic Fibrosis
- Genetic Modifiers of Cystic Fibrosis (CF) Liver Disease โ Chapel Hill, North Carolina
- Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age โ Orange, California
- Hyperpolarized Imaging for New Treatments โ Cincinnati, Ohio
- Monitoring Response to Orkambi in Cystic Fibrosis Lung Disease by Inhaled Xenon MRI โ Cincinnati, Ohio
- Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older โ Nedlands,
- Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis โ Cincinnati, Ohio
Explore by condition: All Cystic Fibrosis clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.