Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07531251 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Clinical Trial in Patients With Barth Syndrome- 4TAZPower

Study acronym: 4TAZPower
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: details revised at 1 of 7 entries
    • Site details revised at 2 of 3 sites
    • Eligibility criteria expanded, about 1 word
  2. Recruitment opened
    • Study sites: 2 to 3
    • Start date changed from estimate of Jun 30, 2026 to Jul 2, 2026
    v4
  3. Study title expanded, about 1 wordv3
  4. Study sites: 1 to 2
    • Secondary endpoints: 9 to 7
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint.
Trial Details
NCT Number NCT07531251
Lead Sponsor Stealth BioTherapeutics Inc.
Conditions
(from sponsor)		 Barth Syndrome
Related terms Barth Syndrome
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov