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NCT00553631 · ClinicalTrials.gov registry record · Phase 3
Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 34
- Enrollment target
NCT00553631: Completed Phase 3 study, sponsored by Shire.
NCT00553631 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 34 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00553631, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 34 participants
- Enrollment target
Study Summary
Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. The purpose of this non-inferiority study is to evaluate the efficacy and safety of GA-GCB (velaglucerase alfa) administered every other week in comparison to imiglucerase in treatment naive patients with type 1 Gaucher disease.
Interventions
- BIOLOGICAL velaglucerase alfa
- BIOLOGICAL imiglucerase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2008-01-29 |
| Est. Completion | 2009-05-05 |
| Phase | Phase 3 |
What the finished NCT00553631 record still lists
NCT00553631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which velaglucerase alfa is the first listed.
NCT00553631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00553631 about?
NCT00553631 is a clinical study titled "Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease". Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. The purpose of t...
What is the current status of trial NCT00553631?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2008-01-29. Estimated completion is 2009-05-05.
What interventions are being tested in trial NCT00553631?
The interventions under investigation include: velaglucerase alfa (BIOLOGICAL), imiglucerase (BIOLOGICAL).
Who is sponsoring clinical trial NCT00553631?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00553631's enrollment target sits among peer trials
34 1905th of 2000 higher than 94 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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