A Global Prospective Observational Registry of Patients With Pompe Disease

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

Conditions

Pompe Disease

Study Overview

Study Details

Study overview

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

A Global Prospective Observational Registry of Patients With Pompe Disease

A Global Prospective Observational Registry of Patients With Pompe Disease

Condition
Pompe Disease
Intervention / Treatment

-

Contacts and Locations

Little Rock

University of Arkansas Medical Science, Little Rock, Arkansas, United States, 72205

Irvine

University of California Irvine, Irvine, California, United States, 92697

Jacksonville

Wolfson Children's Hospital, Jacksonville, Florida, United States, 32207

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Indianapolis

Indiana University, IU Health Physicians Neurology, Indianapolis, Indiana, United States, 46202

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

New York

NYU Neurogenetics, NYU Langone Medical Center, New York, New York, United States, 10017

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Cincinnati

University of Cincinnati Medical Center, Cincinnati, Ohio, United States, 45219

Cincinnati

Cincinnati Children's Hospital, Cincinnati, Ohio, United States, 45229

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of LOPD or IOPD based on documented deficiency of GAA enzyme activity and/or GAA genotyping
  • * Patients who are currently receiving investigational therapy for Pompe disease in a clinical trial, a compassionate use program, or an expanded access program (EAP)

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amicus Therapeutics,

Study Record Dates

2034-12-20