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

NCT06324396 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-02

No results posted yet for this study

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.

Conditions

  • Fontan Circulation

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.

Sponsors & Collaborators

  • Indiana Clinical and Translational Sciences Institute

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Jonathan Wagner, DO · Children's Mercy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06324396 on ClinicalTrials.gov