Danon Disease Natural History Study

NCT ID: NCT06214507

Last Updated: 2026-01-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-20

Study Completion Date

2030-03-31

Brief Summary

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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).

Detailed Description

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This is an international observational study with both retrospective and prospective data collection. The study is designed to describe the natural history of Danon disease, a rare X-linked genetic disorder, and one of the most severe and penetrant forms of inherited cardiomyopathy. This study will collect data about the clinical course of Danon disease, including signs and symptoms, key clinical events, and the impact of the disease on quality of life as managed with the current standard of care. A hybrid (retrospective and prospective data collection) approach is being used to generate robust and longitudinal data. A subset of patients will be used as an External Control Arm for comparison to RP-A501 Trial participants.

Conditions

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Danon Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective Cohort

No intervention

Intervention Type OTHER

No intervention

Retrospective Cohort

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rocket Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

University of California, San Diego

La Jolla, California, United States

Site Status RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

University of Florida College of Medicine

Gainesville, Florida, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Washington University

St Louis, Missouri, United States

Site Status RECRUITING

Columbia University Medical Center/New York Presbyterian

New York, New York, United States

Site Status RECRUITING

Texas Children's Hospital

Houston, Texas, United States

Site Status RECRUITING

German Heart Center Munich

München, , Germany

Site Status RECRUITING

Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Azienda Ospedaliero Universitaria

Florence, , Italy

Site Status RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Site Status RECRUITING

University College London - Great Ormond Street Institute of Child Health

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Germany Israel Italy Spain United Kingdom

Central Contacts

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Clinical Information

Role: CONTACT

646-627-0033

Facility Contacts

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Andrew Papez, MD

Role: primary

(602) 546-0512

Sanjana Khanna

Role: backup

6029334482

Kim Hong, MD

Role: primary

(858) 246-2996

Matthew Taylor, MD, PhD

Role: primary

(720) 848-1030

Mohammed M Ahmed, MD

Role: primary

(352) 273-7770

Supriya Shore

Role: primary

Charles Canter, MD

Role: primary

314-286-2404

Teresa Roberson

Role: backup

314-302-7209

Farhana Latif

Role: primary

(212) 305-3172

Jessica Idumonyi

Role: backup

Kyle Hope, MD

Role: primary

(832) 822-4280

David Garuba

Role: backup

8328265622

Cordula Wolf, MD

Role: primary

+498912182877

Yair Anikster, PhD

Role: primary

+97235305018

Iacopo Olivotto, PhD

Role: primary

+39557945138

Pavia Garcia

Role: primary

Juan Kaski, MD

Role: primary

+4402074059200

Other Identifiers

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RP-NI-A501-0223

Identifier Type: -

Identifier Source: org_study_id

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