Children's National

Evaluation of Fontan-Associated Liver Disease

Purpose

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

Condition

Single Ventricle Heart Disease

Eligibility

Eligible Ages: Over 12 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Enrollment in on-going Phase 3 Open-Label Safety Study 2. 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 2. Subjects with contra-indications for MRI (these subjects will be excluded from the MRI component of this study) 3. Other exclusionary criteria will match those used for the Open-Label Safety Study

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
MZ101	Dosing per treatment regimen	Drug: MZ101 Drug

Recruiting Locations

More Details

NCT ID: NCT03430583
Status: Unknown status
Sponsor: Mezzion Pharma Co. Ltd

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.