Current Environment:

Summary

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

Conditions

Single Ventricle Heart Disease

Recruitment Status

Active, not recruiting

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: