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NCT01380743 · ClinicalTrials.gov registry record · Phase 2
Drug-drug Interaction Study
A Phase 2 study of Pompe Disease, sponsored by Amicus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 15
- Study locations
NCT01380743: Completed Phase 2 study of Pompe Disease, sponsored by Amicus Therapeutics.
NCT01380743 is a Phase 2 study of Pompe Disease that has completed, run by Amicus Therapeutics. The registered enrollment target is 25 participants, below the 231-participant average among 14 other Pompe Disease trials with a reported enrollment target (89% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01380743, a Phase 2 study of Pompe Disease, has completed, sponsored by Amicus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 15
- Study locations
Study Summary
This study evaluates drug-drug interactions between AT2220 (duvoglustat) and recombinant human alpha-glucosidase (rhGAA, also known as alglucosidase alfa) in participants with Pompe Disease.
Primary Outcome
A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of investigational medicinal product (IMP), or an AE with an onset date before the first dose date that worsened in severity after the first dose date. A severe AE was defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced 1 or more severe TEAEs after dosing on Day 1 up to Day 60 (includes end of study follow-up period) is reported. A summary
Conditions Studied
Interventions
- DRUG duvoglustat
- DRUG rhGAA
Study Locations (15)
Arizona
- - Phoenix
- - Scottsdale
Other
- - Paris
- - Salford
California
- - Orange
Florida
- - Gainesville
Georgia
- - Decatur
Kansas
- - Kansas City
Montana
- - Great Falls
North Carolina
- - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-10-31 |
| Est. Completion | 2013-01-04 |
| Phase | Phase 2 |
What the finished NCT01380743 record still lists
NCT01380743 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 231-participant average among 14 other Pompe Disease trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Pompe Disease appearing as the primary indexed condition, and to 2 interventions - of which duvoglustat is the first listed.
NCT01380743 lists 15 locations in 13 states (Arizona, Other, California).
Frequently Asked Questions
What is clinical trial NCT01380743 about?
NCT01380743 is a clinical study titled "Drug-drug Interaction Study". This study evaluates drug-drug interactions between AT2220 (duvoglustat) and recombinant human alpha-glucosidase (rhGAA, also known as alglucosidase alfa) in participants with Pompe Disease.
What is the current status of trial NCT01380743?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2011-10-31. Estimated completion is 2013-01-04.
What conditions does trial NCT01380743 study?
This clinical trial studies the following conditions: Pompe Disease.
What interventions are being tested in trial NCT01380743?
The interventions under investigation include: duvoglustat (DRUG), rhGAA (DRUG).
Who is sponsoring clinical trial NCT01380743?
This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01380743 being conducted?
This trial has 15 study locations across Arizona, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01380743's enrollment target sits among peer trials
25 8th of 14 higher than 7 of 14 other Pompe Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pompe Disease 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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