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NCT00943111 · ClinicalTrials.gov registry record · Phase 3
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
A Phase 3 study of Gaucher Disease, Type 1, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT00943111 is a Phase 3 study of Gaucher Disease, Type 1 that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 160 participants, above the 39-participant average among 8 other Gaucher Disease, Type 1 trials with a reported enrollment target (310% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT00943111, a Phase 3 study of Gaucher Disease, Type 1, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals with enzyme replacement therapy (ERT).
Conditions Studied
Interventions
- DRUG Eliglustat tartrate
- DRUG Imiglucerase
Study Locations (20)
New York
- Albany Medical Center - Albany
- North Shore University Medical Center - Manhasset
- Mount Sinai School of Medicine - New York
- New York University School of Medicine - New York
Other
- Hospital General de Agudos J.M Ramos Mejia - Buenos Aires
- Hospital General de Ninos Dr. Ricardo Gutierrez - Buenos Aires
- Royal Perth Hospital - Perth, WA
California
- Tower Hematology Oncology Medical Group - Beverly Hills
- UCSF MS Center - San Francisco
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Colorado
- University of Colorado Health Science Center - Aurora - Aurora
Connecticut
- Yale University School of Medicine - New Haven
Florida
- Northwest Oncology Hematology Associates PA - Coral Springs
Georgia
- Emory University Medical Genetics - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2009-09 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00943111
The ClinicalTrials.gov registry entry for NCT00943111 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 39-participant average among 8 other Gaucher Disease, Type 1 trials with a reported enrollment target (310% higher). The listed sponsor is Genzyme, a Sanofi Company, which has 196 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 2 interventions - of which Eliglustat tartrate is the first listed.
NCT00943111 reports 20 study locations spanning 13 distinct geographic areas - top geographies include New York, Other, California.
Frequently Asked Questions
What is clinical trial NCT00943111 about?
NCT00943111 is a clinical study titled "A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)". This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals with enzyme replacement therapy (ERT).
What is the current status of trial NCT00943111?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2009-09. Estimated completion is 2015-06.
What conditions does trial NCT00943111 study?
This clinical trial studies the following conditions: Gaucher Disease, Type 1.
What interventions are being tested in trial NCT00943111?
The interventions under investigation include: Eliglustat tartrate (DRUG), Imiglucerase (DRUG).
Who is sponsoring clinical trial NCT00943111?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00943111 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. 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.