RECRUITING

A Global Prospective Observational Registry of Patients With Pompe Disease

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a global, multicenter, prospective, observational registry of patients with Pompe disease, including those with late-onset pompe disease (LOPD) and infantile-onset pompe disease (IOPD). Both untreated patients and those being treated with an approved therapy for Pompe disease are eligible to participate. The objectives of the registry are: * To evaluate the long-term safety of Pompe disease treatments through collection of data that describe the frequency of adverse events (AEs)/serious adverse events (SAEs) occurring in Pompe disease patients * To evaluate the long-term real-world effectiveness of Pompe disease treatments * To evaluate the long-term real-world impact of Pompe disease treatments on quality of life (QOL) and patient-reported outcomes (PROs) * To describe the natural history of untreated Pompe disease

Official Title

A Global Prospective Observational Registry of Patients With Pompe Disease

Quick Facts

Study Start:2024-02-16
Study Completion:2034-12-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06121011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of LOPD or IOPD based on documented deficiency of GAA enzyme activity and/or GAA genotyping
  1. * Patients who are currently receiving investigational therapy for Pompe disease in a clinical trial, a compassionate use program, or an expanded access program (EAP)

Contacts and Locations

Study Contact

For Site
CONTACT
215-921-7600
PompeSiteInfo@amicusrx.com
For Patient
CONTACT
215-921-7600
patientadvocacy@amicusrx.com

Study Locations (Sites)

University of Arkansas Medical Science
Little Rock, Arkansas, 72205
United States
University of California Irvine
Irvine, California, 92697
United States
Wolfson Children's Hospital
Jacksonville, Florida, 32207
United States
Emory University
Atlanta, Georgia, 30322
United States
Indiana University, IU Health Physicians Neurology
Indianapolis, Indiana, 46202
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
NYU Neurogenetics, NYU Langone Medical Center
New York, New York, 10017
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
Lysosomal and Rare Disorders Research and Treatment Center, Inc.
Fairfax, Virginia, 22030
United States

Collaborators and Investigators

Sponsor: Amicus Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-16
Study Completion Date2034-12-20

Study Record Updates

Study Start Date2024-02-16
Study Completion Date2034-12-20

Terms related to this study

Additional Relevant MeSH Terms

  • Pompe Disease