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NCT06324396 · ClinicalTrials.gov registry record · Phase 1
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
A Phase 1 study of Fontan Circulation, sponsored by Children's Mercy Hospital Kansas City.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06324396: Recruiting Phase 1 study of Fontan Circulation, sponsored by Children's Mercy Hospital Kansas City.
NCT06324396 is a Phase 1 study of Fontan Circulation that is actively recruiting participants, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06324396, a Phase 1 study of Fontan Circulation, is actively recruiting participants, sponsored by Children's Mercy Hospital Kansas City.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Area under the time-exposure curve (AUC 0-n) for sildenafil as determinants of the dose-exposure relationship.
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 |
What NCT06324396 shows while recruiting
NCT06324396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
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.
NCT06324396 reports a single indexed study location in Missouri.
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.
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).
Who is sponsoring clinical trial NCT06324396?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Fontan Circulation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06324396's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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