Long-term Follow-up Study of Gene Therapy for Arrhythmogenic Cardiomyopathy Due to a Plakophilin-2 Pathogenic Variant
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- Lexeo Therapeutics
- Study ID
- NCT07050160
- Status
- Enrolling By Invitation
Conditions
- Arrhythmogenic Cardiomyopathy
- PKP2-ACM
- PKP2-ARVC
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 67 Years
- Healthy Volunteers
- Not accepted
Study Details
The primary objective of this Phase 1/2 long-term follow-up (LTFU) study is to assess the long-term safety and tolerability of LX2020 for the treatment of arrhythmogenic cardiomyopathy (ACM) due to a plakophilin-2 gene (PKP2) pathogenic variant (PKP2-ACM).
Key Dates
- First listed
- Jul 3, 2025
- Start date
- Aug 29, 2025
- Status verified
- Nov 2025
- Primary completion
- Aug 31, 2030
- Completion
- Aug 31, 2030
Study Design
- Enrollment
- 10 participants (estimated)
Arms
- Arm: LX2020 treated participantsParticipants who received LX2020 in Study LX2020-01
Primary Outcome Measure
Percentage of subjects who experienced at least 1 treatment emergent adverse event (TEAE) and/or 1 treatment emergent serious adverse event (TESAE). [ Time Frame: 4 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | - |
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