Trials / Completed
CompletedNCT03430583
Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness
Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Mezzion Pharma Co. Ltd · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Udenafil | Open-label extension with Udenafil 87.5 mg BID treatment for 52 weeks. |
Timeline
- Start date
- 2018-02-20
- Primary completion
- 2020-09-15
- Completion
- 2020-09-16
- First posted
- 2018-02-13
- Last updated
- 2025-10-14
- Results posted
- 2025-09-18
Locations
17 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03430583. Inclusion in this directory is not an endorsement.