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 |
|
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.