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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.

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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

FieldValue
Enrollment Target 160 participants
Start Date 2009-09
Est. Completion 2015-06
Phase Phase 3

Sponsor

Genzyme, a Sanofi Company

196 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.