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NCT00635427 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease
A Phase 3 study of Gaucher Disease, Type 1, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT00635427: Completed Phase 3 study of Gaucher Disease, Type 1, sponsored by Shire.
NCT00635427 is a Phase 3 study of Gaucher Disease, Type 1 that has completed, run by Shire. The registered enrollment target is 95 participants, above the 47-participant average among 8 other Gaucher Disease, Type 1 trials with a reported enrollment target (102% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00635427, a Phase 3 study of Gaucher Disease, Type 1, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the long-term safety of every other week dosing of Gene-Activated® human glucocerebrosidase (GA-GCB, velaglucerase alfa) intravenously in patients with type 1 Gaucher disease.
Primary Outcome
Safety was evaluated by an analysis of adverse events (AEs), concomitant medication use, clinical laboratory tests, vital signs during the infusion of study drug, physical examination, and the development of anti-velaglucerase alfa. No formal comparisons or statistical tests were applied for the safety analyses, including for differences between the groups.
Conditions Studied
Interventions
- BIOLOGICAL VPRIV®
Study Locations (20)
Other
- Your Health S.A. - Buenos Aires
- All India Institute of Medical Sciences - New Delhi
- KEM Hospital - Pune
- Shaare Zedek Medical Center - Jerusalem
- Sociedad Espanola de Socorros Mutuos - Asunción
- Instytut "Pomnik-Centrum Zdrowia Dziecka" - Warsaw
- State Institution "Hematology Research Centre RAMS" - Moscow
- Hospital Universitario Miguel Servet - Zaragoza
California
- Los Angeles Medical Center - Los Angeles
- Children's Hospital Oakland - Oakland
Georgia
- Emory University School of Medicine - Atlanta
Illinois
- Children's Memorial Hospital - Chicago
Minnesota
- Children's Hospitals and Clinics of Minnesota - Minneapolis
Missouri
- Children's Mercy Hospitals & Clinics - Kansas City
New York
- NYU Medical Center - New York
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2008-03-13 |
| Est. Completion | 2012-12-28 |
| Phase | Phase 3 |
What the finished NCT00635427 record still lists
NCT00635427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 47-participant average among 8 other Gaucher Disease, Type 1 trials with a reported enrollment target (102% higher).
The record links to 1 condition, with Gaucher Disease, Type 1 appearing as the primary indexed condition, and to 1 intervention - of which VPRIV® is the first listed.
NCT00635427 names 20 study sites across 12 states, led by Other, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00635427 about?
NCT00635427 is a clinical study titled "An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease". The purpose of this study is to evaluate the long-term safety of every other week dosing of Gene-Activated® human glucocerebrosidase (GA-GCB, velaglucerase alfa) intravenously in patients with type 1 Gaucher disease.
What is the current status of trial NCT00635427?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2008-03-13. Estimated completion is 2012-12-28.
What conditions does trial NCT00635427 study?
This clinical trial studies the following conditions: Gaucher Disease, Type 1.
What interventions are being tested in trial NCT00635427?
The interventions under investigation include: VPRIV® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00635427?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00635427 being conducted?
This trial has 20 study locations across California, Georgia, Illinois, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gaucher Disease, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00635427's enrollment target sits among peer trials
95 2nd of 8 the highest of 8 other Gaucher Disease, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gaucher Disease, Type 1 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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