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

RecruitingPhase 1Ages 8 Years - anyAllChildren's Mercy Hospital Kansas City
NCT06324396 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • 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)
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Where

1 site
Children's Mercy Hospital
Kansas City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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