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Clinical Trials in the UK / NCT06214507
Recruiting Observational

Danon Disease Natural History Study

NCT06214507 · tracked via the Priya Life Science UK tracker
Sponsor
Rocket Pharmaceuticals Inc.
Phase
Observational
Started
2023-12-20
Last updated
2026-07-28

Condition(s) studied

Danon Disease

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention

Study summary

The goal of this international observational study is to learn about the natural history of Danon disease in male patients (≥8 years of age) and female patients (8 to 50 years of age).

Eligibility

Sex
ALL
Min age
8 Years
Max age
Healthy volunteers
No
Prospective Cohort: 1. Documentation of a pathogenic or likely pathogenic variant of the LAMP2 gene by a CLIA-certified genetic testing laboratory 2. Patient or parent/legal guardian are capable and willing to provide signed informed consent 3. Age ≥ 8 years at enrollment Female Prospective Cohort: 4. Evidence of left ventricular hypertrophy in the 12 months prior to or at enrollment. Retrospective (only) Cohort: 5. Documentation of a pathogenic or likely pathogenic variant of the LAMP2 gene by a CLIA-certified genetic testing laboratory 6. Patient or parent/legal guardian are capable and willing to provide signed informed consent, as required by local regulations 7. Age ≥ 8 years at enrollment 8. Prior cardiac transplantation or prior mechanical circulatory support 9. At least 30 days of retrospective medical records available prior to cardiac transplantation or mechanical circulatory support Female Retrospective (only) Cohort: 10. Prior evidence of left ventricular hypertrophy. Key Exclusion Criteria: All Cohorts: 1. Concurrent enrollment in any other clinical investigation involving use of an investigational agent for any condition at time of enrollment to this study that could confound interpretation of this study 2. Previous treatment with a gene therapy Prospective Cohort: 3. Prior mechanical circulatory support at time of enrollment to this study 4. Prior cardiac transplantation at time of enrollment to this study Female patients: 5. Age \>51 years at enrollment

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Phoenix Children's Hospital Phoenix Arizona Recruiting
University of California, San Diego La Jolla California Recruiting
Children's Hospital Colorado Aurora Colorado Recruiting
University of Florida College of Medicine Gainesville Florida Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Washington University St Louis Missouri Recruiting
Columbia University Medical Center/New York Presbyterian New York New York Recruiting
University of Texas, Southwestern Dallas Texas Recruiting
Texas Children's Hospital Houston Texas Recruiting
German Heart Center Munich München Germany Recruiting
Sheba Medical Center Ramat Gan Israel Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy Recruiting
Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Madrid Recruiting
Sant Joan de Déu Hospital Barcelona Spain Recruiting
University College London - Great Ormond Street Institute of Child Health London United Kingdom Recruiting

More Rocket Pharmaceuticals Inc. trials in the UK

Other trials for the same condition

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 NCT06214507 on ClinicalTrials.gov ↗ ← All trials in the UK