Clinical Trial

IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease

Study acronym: IMPROVE-FALD
Recruiting Phase 1
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Summary
This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-03-20; most recent amendment 2025-12-31.
Trial Details
NCT Number NCT06324396
Lead Sponsor Children's Mercy Hospital Kansas City
Collaborators: Indiana Clinical and Translational Sciences Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Fontan Circulation
Enrollment 15 participants
Start Date 2024-03-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-02