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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00635427
The ClinicalTrials.gov registry entry for NCT00635427 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 47-participant average among 8 other Gaucher Disease, Type 1 trials with a reported enrollment target (102% higher). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.