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NCT00526071 · ClinicalTrials.gov registry record · Phase 2
Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study
A Phase 2 study, sponsored by Amicus Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT00526071: Clinical Trial Phase 2 study, sponsored by Amicus Therapeutics.
NCT00526071 is a Phase 2 study that was terminated before completion, run by Amicus Therapeutics. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00526071, a Phase 2 study, was terminated before completion, sponsored by Amicus Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease
Primary Outcome
A TEAE was defined as any adverse event (AE) with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe AE was defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through End of Study (EOS) or follow-up (for participants who did not enroll in Study AT1001-041) are
Interventions
- DRUG migalastat HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2007-09-17 |
| Est. Completion | 2012-09-08 |
| Phase | Phase 2 |
Why NCT00526071 stopped before completion
NCT00526071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which migalastat HCl is the first listed.
NCT00526071 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00526071 about?
NCT00526071 is a clinical study titled "Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study". Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease
What is the current status of trial NCT00526071?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2007-09-17. Estimated completion is 2012-09-08.
What interventions are being tested in trial NCT00526071?
The interventions under investigation include: migalastat HCl (DRUG).
Who is sponsoring clinical trial NCT00526071?
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 NCT00526071's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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