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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 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 34 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00553631
The ClinicalTrials.gov registry entry for NCT00553631 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which velaglucerase alfa is the first listed.
NCT00553631 reports 0 study locations.
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.
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