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NCT00376168 · ClinicalTrials.gov registry record · Phase 3
A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease
A Phase 3 study of Gaucher Disease, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
- 11
- Study locations
NCT00376168: Completed Phase 3 study of Gaucher Disease, sponsored by Pfizer.
NCT00376168 is a Phase 3 study of Gaucher Disease that has completed, run by Pfizer. The registered enrollment target is 32 participants, below the 1,056-participant average among 13 other Gaucher Disease trials with a reported enrollment target (97% lower). The trial reports 11 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00376168, a Phase 3 study of Gaucher Disease, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
- 11
- Study locations
Study Summary
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system. This is the second trial to utilize a recombinant active form of lysosomal enzyme, glucocerebrosidase, (human prGCD) which is expressed and purified in a bioreactor system from transformed carrot plant root cell line.
Primary Outcome
Calculated as percent change in spleen volume from Baseline to 9 months
Conditions Studied
Interventions
- DRUG Plant cell expressed recombinant glucocerebrosidase (prGCD)
Study Locations (11)
Other
- Pontificia Universidad Catolica de Chile - Santiago
- Rambam Medical Center - Haifa
- Shaare Zedek Medical Center - Jerusalem
- Universita "La Sapienza" - Rome
- Morningside Medi-Clinic - Morningside
- Hospital Universitario Miguel Servet - Zaragoza
- Royal Free Hospital - London
Florida
- University Research Foundation for Lysosomal Storage Diseases - Coral Springs
Georgia
- Division of Medical Genetics, Emory University School of Medicine - Decatur
New York
- New York University Medical Center - New York
Ontario
- Mount Sinai Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00376168 record still lists
NCT00376168 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,056-participant average among 13 other Gaucher Disease trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Gaucher Disease appearing as the primary indexed condition, and to 1 intervention - of which Plant cell expressed recombinant glucocerebrosidase (prGCD) is the first listed.
NCT00376168 lists 11 locations in 5 states (Other, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT00376168 about?
NCT00376168 is a clinical study titled "A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease". Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte...
What is the current status of trial NCT00376168?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2007-08. Estimated completion is 2009-10.
What conditions does trial NCT00376168 study?
This clinical trial studies the following conditions: Gaucher Disease.
What interventions are being tested in trial NCT00376168?
The interventions under investigation include: Plant cell expressed recombinant glucocerebrosidase (prGCD) (DRUG).
Who is sponsoring clinical trial NCT00376168?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00376168 being conducted?
This trial has 11 study locations across Florida, Georgia, New York, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00376168's enrollment target sits among peer trials
32 6th of 13 higher than 8 of 13 other Gaucher Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gaucher 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.
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