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NCT00813865 · ClinicalTrials.gov registry record · Phase 2
A Long-Term Extension Study of AT2101 (Afegostat Tartrate) in Type 1 Gaucher Patients
A Phase 2 study, sponsored by Amicus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT00813865: Completed Phase 2 study, sponsored by Amicus Therapeutics.
NCT00813865 is a Phase 2 study that has completed, run by Amicus Therapeutics. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00813865, a Phase 2 study, has completed, sponsored by Amicus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study evaluated the long-term safety and efficacy of afegostat tartrate in participants with Gaucher disease who were enrolled in a previous Phase 2 study of afegostat tartrate.
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 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 through the end of follow-up is presented. A summary of serious and all other non-serious AEs regardless of
Interventions
- DRUG afegostat tartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2009-05-11 |
| Est. Completion | 2012-05-01 |
| Phase | Phase 2 |
What the finished NCT00813865 record still lists
NCT00813865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which afegostat tartrate is the first listed.
NCT00813865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00813865 about?
NCT00813865 is a clinical study titled "A Long-Term Extension Study of AT2101 (Afegostat Tartrate) in Type 1 Gaucher Patients". This study evaluated the long-term safety and efficacy of afegostat tartrate in participants with Gaucher disease who were enrolled in a previous Phase 2 study of afegostat tartrate.
What is the current status of trial NCT00813865?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2009-05-11. Estimated completion is 2012-05-01.
What interventions are being tested in trial NCT00813865?
The interventions under investigation include: afegostat tartrate (DRUG).
Who is sponsoring clinical trial NCT00813865?
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 NCT00813865's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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