Status:
COMPLETED
A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With LOPD
Lead Sponsor:
Amicus Therapeutics
Conditions:
Pompe Disease (Late-onset)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.
Detailed Description
This is an open label extension study for subjects who completed the ATB200-03 study. The subjects will stay in this study until regulatory approval or marketing authorization and/or commercialization...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 1\. Subject must have completed Study ATB200-03.
- Exclusion Criteria
- Subject plans to receive gene therapy or participate in another interventional study for Pompe disease.
- Subject, if female, is pregnant or breastfeeding.
- Subject, whether male or female, is planning to conceive a child during the study.
Exclusion
Key Trial Info
Start Date :
December 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT04138277
Start Date
December 18 2019
End Date
December 31 2024
Last Update
October 16 2025
Active Locations (60)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
University of California, Irvine
Irvine, California, United States, 92868
3
University of Florida Clinical Research Center
Gainesville, Florida, United States, 32610
4
Emory Clinic
Atlanta, Georgia, United States, 30322