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IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
NCT06324396 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg)
- DRUG Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)
Study Locations (1)
Missouri
- Children's Mercy Hospital — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06324396
The ClinicalTrials.gov registry entry for NCT06324396 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Mercy Hospital Kansas City, which has 93 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Fontan Circulation appearing as the primary indexed condition, and to 2 interventions — of which Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06324396 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06324396 about?
NCT06324396 is a clinical study titled "IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease". 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.
What is the current status of trial NCT06324396?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-03-01. Estimated completion is 2026-12-31.
What conditions does trial NCT06324396 study?
This clinical trial studies the following conditions: Fontan Circulation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06324396?
The interventions under investigation include: Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg) (DRUG), Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06324396?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 93 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06324396 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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