A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome

Exclusion Criteria

• •Participated in another interventional clinical trial within 30 days of or is currently enrolled in a non-interventional clinical trial at the baseline visit potentially confounding with this trial
• •Prior or current medical condition that would prevent the subject from safely participating in the trial
• •Undergone any inpatient hospitalizations within 30 days of the baseline visit
• •Is undergoing an apparent pubertal growth spurt
• •Has uncontrolled hypertension
• •History of substance abused within the year before the baseline visit or is likely to be uncompliant
• •History of heart transplantation or current placement on the waiting list for a heart transplant
• •For subjects with an ICD: known occurrence of ICD discharge in the 3 months prior to the baseline visit
• •For subjects without an ICD: expected to undergo an implantation of an ICD during the conduct of the study
• •Currently receiving treatment with chemotherapeutic agents or immunosuppressant agents or has received prior radiation therapy to the chest
• •Recipient of stem cell or gene therapy or is currently being treated by a therapeutic investigational device