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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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
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, categorized as Phase 1. 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 184 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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