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

Study acronym: IMPROVE-FALD
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v3
  2. Collaborators: 1 to 2
    • Eligibility criteria expanded, about 5 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Fontan Circulation
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov