IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
NCT ID: NCT06324396
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2024-03-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Assessment Arm
Assessment group will receive a single dose of oral sildenafil and oral pravastatin.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Status Post Fontan Completion
* Ability to provide informed permission-assent (\<18 years) or consent (≥18 years)
* Fasting overnight (\~8 hours)
Exclusion Criteria
* 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
8 Years
ALL
No
Sponsors
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Indiana Clinical and Translational Sciences Institute
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Children's Mercy Hospital Kansas City
OTHER
Responsible Party
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Jon Wagner
Director, Division of Clinical Pharmacology, Toxicology, and Therapeutic Innovation
Principal Investigators
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Jonathan Wagner, DO
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy
Locations
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Children's Mercy Hospital
Kansas City, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Jonathan Wagner, DO
Role: primary
Other Identifiers
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STUDY00002974
Identifier Type: -
Identifier Source: org_study_id
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