Phase 3
Completed N=88
Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness
Source: ClinicalTrials.gov NCT03430583 ↗Enrolled (actual)
88
Serious AEs
—
Results posted
Sep 2025
Primary outcomePrimary: Effect of Udenafil 87.5 mg BID Treatment on Liver Stiffness in Udenafil Continuation and Naive Groups After 52 Weeks, as Determined by Ultrasound Shear Wave Elastography — 1.91; 2.02; 1.97; 1.86 meters per second
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Udenafil 87.5 mg BID Treatment on Liver Stiffness in Udenafil Continuation and Naive Groups After 52 Weeks, as Determined by Ultrasound Shear Wave Elastography |
1.91; 2.02; 1.97; 1.86; 1.96; 1.92 | — |
| PRIMARY Effect of Udenafil 87.5 mg BID Treatment on Liver Stiffness in Udenafil Continuation and Naive Groups After 52 Weeks, as Determined by Magnetic Resonance Elastography |
5.26; 5.26; 5.26; 4.95; 5.50; 5.20 | — |
| SECONDARY Effect of Udenafil 87.5 mg BID on Enhanced Liver Fibrosis (ELF) Score After 52 Weeks of Treatment |
10.58; 10.45; 10.50; 9.72; 9.79; 9.76 | — |
| SECONDARY Effect of Udenafil 87.5 mg BID on Brain Natriuretic Peptide After 52 Weeks of Treatment |
16.89; 17.20; 17.07; 20.31; 20.78; 20.59 | — |
Eligibility Criteria
Inclusion Criteria
- Enrollment in on-going Phase 3 Open-Label Safety Study
- Informed assent from subject, informed consent from parent/legal guardian as appropriate
Exclusion Criteria
- Non-enrollment in the on-going Phase 3 Open-Label Study
- Subjects with contra-indications for MRI (these subjects will be excluded from the MRI component of this study)
- Other exclusionary criteria will match those used for the Open-Label Safety Study
Data sourced from ClinicalTrials.gov (NCT03430583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.