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NCT03729362 · ClinicalTrials.gov registry record · Phase 3

A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease

A Phase 3 study, sponsored by Amicus Therapeutics.

Completed
Registry status
Phase 3
Development phase
125
Enrollment target

NCT03729362 is a Phase 3 study that has completed, run by Amicus Therapeutics. The registered enrollment target is 125 participants.

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The verdict

NCT03729362, a Phase 3 study, has completed, sponsored by Amicus Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
125 participants
Enrollment target

Study Summary

This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.

Interventions

  • DRUG Placebo
  • DRUG Miglustat
  • BIOLOGICAL Cipaglucosidase Alfa
  • BIOLOGICAL Alglucosidase Alfa

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2018-12-04
Est. Completion 2021-01-15
Phase Phase 3

Sponsor

Amicus Therapeutics

34 total trials

What the Registry Record Tells You About NCT03729362

The ClinicalTrials.gov registry entry for NCT03729362 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 125 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 4 interventions - of which Placebo is the first listed.

NCT03729362 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03729362 about?

NCT03729362 is a clinical study titled "A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease". This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.

What is the current status of trial NCT03729362?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2018-12-04. Estimated completion is 2021-01-15.

What interventions are being tested in trial NCT03729362?

The interventions under investigation include: Placebo (DRUG), Miglustat (DRUG), Cipaglucosidase Alfa (BIOLOGICAL), Alglucosidase Alfa (BIOLOGICAL).

Who is sponsoring clinical trial NCT03729362?

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.