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NCT00891202 · ClinicalTrials.gov registry record · Phase 3
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease (ENGAGE)
A Phase 3 study of Gaucher Disease, Type 1, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
- 18
- Study locations
NCT00891202: Completed Phase 3 study of Gaucher Disease, Type 1, sponsored by Genzyme, a Sanofi Company.
NCT00891202 is a Phase 3 study of Gaucher Disease, Type 1 that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 40 participants, below the 54-participant average among 8 other Gaucher Disease, Type 1 trials with a reported enrollment target (26% lower). The trial reports 18 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00891202, a Phase 3 study of Gaucher Disease, Type 1, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
- 18
- 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.
Primary Outcome
Percent change in spleen volume = (\[spleen volume at Week 39 minus spleen volume at baseline\] divided by \[spleen volume at baseline\]) multiplied by 100, where all volumes are in MN.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Eliglustat tartrate
Study Locations (18)
Other
- University hospital "Alexandrovska" Sofia - Sofia
- Sir Mortimer B. Davis - Jewish General Hospital - Montreal, Quebec
- Mount Sinai Hospital and the Samuel Lunenfeld Research Institute - Toronto Ontario
- Hospital de San Jose - Bogotá
- Christian Medical College Hospital - Vellore
- Rabin Medical Center, Beilinson Hospital - Petach Tikvah
- Hôtel-Dieu de France University Hospital - Beirut
- OCA Hospital - Monterrey, Nuevo Leon
- Hematology Research Center of Ministry of Healthcare of the Russian Federation - Moscow
- Institut za endokrinologiju - Belgrade
- Royal Free Hospital - London
New York
- New York University School of Medicine, Neurology Department - New York
- Mount Sinai School of Medicine - New York
California
- UCSF MS Center - San Francisco
Connecticut
- Yale University School of Medicine - New Haven
Georgia
- Emory University Medical Genetics - Decatur
Kansas
- University of Kansas Medical Center, Division of Hematology/Oncology, Dept. of Medicine - Westwood
TN
- Hopital La-Rabta - Tunis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-11 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT00891202 record still lists
NCT00891202 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 54-participant average among 8 other Gaucher Disease, Type 1 trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Gaucher Disease, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00891202 lists 18 locations in 7 states (Other, New York, California).
Frequently Asked Questions
What is clinical trial NCT00891202 about?
NCT00891202 is a clinical study titled "A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease (ENGAGE)". This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease Type 1.
What is the current status of trial NCT00891202?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2009-11. Estimated completion is 2016-01.
What conditions does trial NCT00891202 study?
This clinical trial studies the following conditions: Gaucher Disease, Type 1.
What interventions are being tested in trial NCT00891202?
The interventions under investigation include: Placebo (DRUG), Eliglustat tartrate (DRUG).
Who is sponsoring clinical trial NCT00891202?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00891202 being conducted?
This trial has 18 study locations across California, Connecticut, Georgia, Kansas, New York. 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 NCT00891202's enrollment target sits among peer trials
40 4th of 8 higher than 5 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
-
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
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-
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A Study of the Efficacy and Safety of Eliglustat Tartrate (Genz-112638) in Type 1 Gaucher Patients
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