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RECRUITING
NCT06324396
PHASE1

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

Sponsor: Children's Mercy Hospital Kansas City

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

8 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2024-03-01

Completion Date

2026-12-31

Last Updated

2026-01-02

Healthy Volunteers

No

Interventions

DRUG

Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg)

A single oral dose of sildenafil will be administered to all study subjects.

DRUG

Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)

A single oral dose of pravastatin will be administered to all study subjects.

Locations (1)

Children's Mercy Hospital

Kansas City, Missouri, United States