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Recruiting NCT06324396

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

Phase I Interventional Fontan Circulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg), Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years).
Who it may be relevant to
Registry conditions: Fontan Circulation. Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • Sildenafil concentration as measured by area under the curve (AUC) [Time frame: 2 years]
  • Pravastatin concentration as measured by area under the curve (AUC) [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • > 8 years
  • Status Post Fontan Completion
  • Ability to provide informed permission-assent (<18 years) or consent (≥18 years)
  • Fasting overnight (\~8 hours)

Exclusion criteria

  • Pregnancy
  • Non-fasting
  • Non-removable metal in body or where magnetic resonance imaging (MRI) is considered unsafe
  • Sildenafil and/or Pravastatin therapy within last 2 months
  • History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter Sildenafil and Pravastatin disposition (absorption, metabolism, distribution, or clearance)
  • Pharmacotherapy that interacts with Sildenafil (cytochrome P450 3A4 and P450 3A5 (CYP3A4/5) inducers/inhibitors) and/or Pravastatin (organic anion transporting polypeptide (OATP1B1) inducers/inhibitors)
  • Inability to swallow a tablet
  • >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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Children's Mercy Hospital — Kansas City

Identifiers

NCT: NCT06324396 · STUDY00002974 · 5T32HD069038

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗