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Gene Therapy for Cardiomyopathy Associated With Friedreich's Ataxia

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv15
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 9 to confirmed 8
    • Study sites: 6 to 3
    v14
  3. Site details revised at 2 of 6 sitesv13
  4. Re-verified, no change to tracked fieldsv12
  5. Study sites: 5 to 6v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 4 to 5v10
  2. Enrollment target: 10 to 9v9 Show 4 more changesShow less
    • Interventions: High Dose LX2006 (Genetic), Low dose LX2006 (Genetic) to High Dose LX2006 (Genetic), Low dose LX2006 (Genetic), Mid Dose LX2006 (Genetic)
    • Eligibility criteria shortened, about 48 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 1 word
  3. Site details revised at 1 of 4 sitesv8
  4. Eligibility criteria shortened, about 20 wordsv7
  5. Site details revised at 1 of 4 sitesv6
  6. Start date changed from estimate of Aug 2022 to Aug 24, 2022v5
  7. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 4 of 4 sites
    v4
  8. Start date: Jul 2022 to Aug 2022v3
  9. Re-verified, no change to tracked fieldsv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase 1/2, open-label, dose-ascending, multicenter study of the safety and efficacy of LX2006 for participants who have Friedreich's Ataxia with evidence of cardiomyopathy. The study will evaluate up to three doses of single administration of LX2006 (AAVrh.10hFXN), an adeno-associated virus (AAV) gene therapy designed to intravenously deliver the human frataxin (hFXN) gene to cardiac cells over a 52-week period. Long-term safety and efficacy will be evaluated for an additional 4-years for a total of 5-years post LX2006 treatment.
Trial Details
NCT Number NCT05445323
Lead Sponsor Lexeo Therapeutics
Conditions
(from sponsor)		 Friedreich Ataxia, Cardiomyopathy, Secondary
Related terms Cardiomyopathies, Friedreich Ataxia
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov