drugset / Trial / NCT00004828
Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
Phase 1
Completed
28 enrolled
FDA Office of Orphan Products Development
Children's Hospital and Health Center · collab
RandomizedTreatment
Summary
OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified Fontan procedure. II. Determine the liothyronine supplementation dose that counters the fall in serum liothyronine concentrations and provides the greatest potential myocardial benefit after the modified Fontan procedure. III. Evaluate the potential toxicity of exogenous liothyronine administered in children undergoing a modified Fontan procedure.
Timeline
- Start
- 1994-12
- Primary completion
- —
- Completion
- 1997-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Liothyronine | Small molecule | — | Other |