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Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness

NCT03430583 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-10-14

Study results available
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Summary

A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.

Conditions

  • Single Ventricle Heart Disease

Interventions

DRUG

Udenafil

Open-label extension with Udenafil 87.5 mg BID treatment for 52 weeks.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Mezzion Pharma Co. Ltd

    lead INDUSTRY

Principal Investigators

  • David J Goldberg, MD · Children's Hospital of Philadelphia

  • Kurt R Schumacher, MD · University of Michigan Congenital Heart Center/C.S. Mott Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-20
Primary Completion
2020-09-15
Completion
2020-09-16
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03430583 on ClinicalTrials.gov