Trials / Recruiting
RecruitingNCT06324396
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Children's Mercy Hospital Kansas City · Academic / Other
- Sex
- All
- Age
- 8 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
| DRUG | 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. |
Timeline
- Start date
- 2024-03-01
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2024-03-22
- Last updated
- 2026-01-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06324396. Inclusion in this directory is not an endorsement.