Summary
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
Conditions
Single Ventricle Heart Disease
Recruitment Status
Unknown status
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.
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
Intervention
Intervention Type
Intervention Name
Drug
MZ101
Gender
All
Min Age
12 Years
Max Age
N/A
Download Date
November 24, 2020
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: