Clinical Trial in Patients With Barth Syndrome- 4TAZPower
Recruiting
Phase 4
Interventional Study
Barth Syndrome
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 5 – 55
- Sex
- Male
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 48 (estimated)
- Sponsor
- Stealth BioTherapeutics Inc. · Industry
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About This Trial
Phase 3b/4, randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the efficacy, safety, and pharmacokinetics of a once daily SC injection of elamipretide in subjects with genetically confirmed BTHS for 72 weeks. The primary trial objective is to confirm the efficacy of elamipretide which is approved in the United States(FORZINITY™) under the accelerated approval b…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
1. Willing and able to provide signed informed consent form (ICF) prior to participation in any trial-related procedures. If applicable, informed consent in writing from parent(s) or legally-acceptable representative(s) and, informed assent from subject (if age appropriate a…
Contacts