Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
65 participants
OBSERVATIONAL
2025-09-30
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: Participants ≥16 years of age with FA-CM
Participants ≥16 years of age with FA-CM
No interventions assigned to this group
Cohort 2: Participants 6 to <16 years of age with FA-CM
Participants 6 to \<16 years of age with FA-CM
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of FA, based on clinical phenotype and genotype (GAA expansion on both alleles), with onset of FA occurring at ≤25 years of age
* Confirmed left ventricular hypertrophy (LVH)
* Left ventricular ejection fraction ≥40%
Exclusion Criteria
* Currently receiving intermittent or continuous intravenous (IV) inotrope infusion, presence of a ventricular assist device, or history of prior heart transplantation
* Contraindication to cMRI
* Prior organ transplantation
* Initiation of cardiac resynchronization therapy (CRT) within 6 months prior to screening.
* History of prior gene transfer or cell therapy.
* Poorly controlled diabetes (hemoglobin A1c ≥8%)
* Active hematologic or solid organ malignancy
6 Years
ALL
No
Sponsors
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Lexeo Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Lexeo Clinical Trials
Role: STUDY_DIRECTOR
Lexeo Therapeutics
Locations
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University of California San Diego
La Jolla, California, United States
University of South Florida
Tampa, Florida, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Centre Hospitalier de Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: backup
Role: primary
Role: primary
Role: primary
Role: backup
Role: primary
Other Identifiers
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LX2006-02
Identifier Type: -
Identifier Source: org_study_id