drugset / Trial / NCT06324396
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
Phase 1
Recruiting
15 enrolled
Children's Mercy Hospital Kansas City
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabIndiana Clinical and Translational Sciences Institute · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-03-01
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pravastatin | Small molecule | 20 mg | Oral |
| Subject | Pravastatin | Small molecule | 40 mg | Oral |
| Subject | Sildenafil | Unknown | 10 mg | Oral |
| Subject | Sildenafil | Unknown | 20 mg | Oral |