clinical trial · NCT03430583
Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness
Mezzion Pharma Co. Ltd·phase3·completed·n = 88
Single Ventricle Heart DiseaseUdenafil
brief summary
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
started
Feb 20, 2018
primary completion
Sep 15, 2020
completion
Sep 16, 2020
last updated
Oct 14, 2025
detailed description
This is open-label, long-term prospective study in a cohort of Fontan subjects taking drug daily for one year. The study will determine the scope of hepatic stiffness in the cohort by ultrasound and magnetic resonance imaging elastography and evaluate MZ101 pharmacotherapy as a potentially efficacious treatment to reduce liver stiffness.
official title
Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol