Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness
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 Sex
- 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
- Phase 3
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Udenafil Continuation (U+) |
Subjects who were receiving Udenafil 87.5 mg BID in FUEL study prior to enrolling to this study (FALD). |
|
|
Experimental Udenafil Naive (U-) |
Subjects who were receiving Placebo BID in FUEL study prior to enrolling to this study (FALD). |
|
Recruiting Locations
More Details
- NCT ID
- NCT03430583
- Status
- Completed
- 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.