Ireland
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Enrolling by invitation Observational

Long-term Follow-up Study of Gene Therapy for Arrhythmogenic Cardiomyopathy Due to a Plakophilin-2 Pathogenic Variant

NCT07050160 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2025-08-29
Last updated
2025-11-12

Condition(s) studied

Arrhythmogenic CardiomyopathyPKP2-ACMPKP2-ARVC

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
67 Years
Healthy volunteers
No
Inclusion Criteria: * Participants who received LX2020 in study LX2020-01 Exclusion Criteria: * Concurrent enrollment in any other clinical investigation involving use of an investigational agent.

Primary outcome measure(s)

  • Percentage of subjects who experienced at least 1 treatment emergent adverse event (TEAE) and/or 1 treatment emergent serious adverse event (TESAE). — 4 years
    Evaluation of Safety and Tolerability of LX2020

Trial sites (1)

FacilityCityRegionStatus
University of Michigan Ann Arbor Michigan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07050160 on ClinicalTrials.gov ↗ ← All trials in the USA