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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 is a Phase 3 study that has completed, run by Amicus Therapeutics. The registered enrollment target is 119 participants.

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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.

Interventions

  • DRUG AT2221
  • BIOLOGICAL ATB200

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2019-12-18
Est. Completion 2024-12-31
Phase Phase 3

Sponsor

Amicus Therapeutics

34 total trials

What the Registry Record Tells You About NCT04138277

The ClinicalTrials.gov registry entry for NCT04138277 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amicus Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which AT2221 is the first listed.

NCT04138277 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.