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NCT04138277 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With Late-Onset Pompe Disease (LOPD)
A Phase 3 study, sponsored by Amicus Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
NCT04138277: Completed Phase 3 study, sponsored by Amicus Therapeutics.
NCT04138277 is a Phase 3 study that has completed, run by Amicus Therapeutics. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04138277, a Phase 3 study, has completed, sponsored by Amicus Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
Study 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.
Primary Outcome
Number of subjects with TEAE, TESAE, and TEAE leading to discontinuation during this long-term extension study
Interventions
- DRUG AT2221
- BIOLOGICAL ATB200
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2019-12-18 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 3 |
What the finished NCT04138277 record still lists
NCT04138277 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which AT2221 is the first listed.
NCT04138277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04138277 about?
NCT04138277 is a clinical study titled "A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With Late-Onset Pompe Disease (LOPD)". 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.
What is the current status of trial NCT04138277?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2019-12-18. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT04138277?
The interventions under investigation include: AT2221 (DRUG), ATB200 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04138277?
This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04138277's enrollment target sits among peer trials
119 1640th of 2000 higher than 360 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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