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Recruiting
NCT06324396
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
Conditions: Fontan Circulation
Sex: All
Ages: 8 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 15
Sponsor: Children's Mercy Hospital Kansas City
Location: Children's Mercy Hospital Kansas City Missouri
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.
Eligibility Criteria
Inclusion Criteria:
* \> 8 years
* Status Post Fontan Completion
* Ability to provide informed permission-assent (\5X the age-specific upper limit of normal for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total and conjugated bilirubin
* Diarrhea in the last 24 hours \*History of solid organ transplantation
Source: ClinicalTrials.gov (NCT06324396). StuddyBuddy aggregates publicly available trial information.