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Eliglustat tartrate

DRUG4 trials

Sponsors

Genzyme, a Sanofi Company

Conditions

Cerebroside Lipidosis SyndromeGaucher DiseaseGaucher Disease, Non-Neuronopathic FormGaucher Disease, Type 1Glucocerebrosidase Deficiency DiseaseGlucosylceramide Beta-Glucosidase Deficiency Disease

Phase 2

A Study of the Efficacy and Safety of Eliglustat Tartrate (Genz-112638) in Type 1 Gaucher Patients
CompletedNCT00358150
Genzyme, a Sanofi CompanyCerebroside Lipidosis Syndrome, Gaucher Disease, Non-Neuronopathic Form, Gaucher Disease, Type 1 +2
Start: 2006-06-30End: 2015-12-31Updated: 2017-02-15

Phase 3

A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease (ENGAGE)
CompletedNCT00891202
Genzyme, a Sanofi CompanyGaucher Disease, Type 1
Start: 2009-11-30End: 2016-01-31Updated: 2017-03-03
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
CompletedNCT00943111
Genzyme, a Sanofi CompanyGaucher Disease, Type 1
Start: 2009-09-30End: 2015-06-30Updated: 2016-11-25
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE)
CompletedNCT01074944
Genzyme, a Sanofi CompanyGaucher Disease
Start: 2010-06-30End: 2015-10-31Updated: 2017-02-06

Related Papers

Plasma glucosylsphingosine correlations with baseline disease burden and response to eliglustat in two clinical trials of previously untreated adults with Gaucher disease type 1
Molecular Genetics and Metabolism2023-01-256 citations
Biomarker Response to Oral Eliglustat in Adults with Gaucher Disease Type 1: Results from 4 Completed Clinical Trials
Blood2019-11-13
PF428 GLUCOSYLSPHINGOSINE (LYSO-GL-1), A BIOMARKER OF GAUCHER DISEASE, CORRELATES WITH DISEASE SEVERITY AND RESPONSE TO ELIGLUSTAT IN 2 CLINICAL TRIALS OF TREATMENT-NAÏVE ADULTS WITH GAUCHER DISEASE TYPE 1
HemaSphere2019-06-01
Long-Term Effects of Oral Eliglustat on Skeletal Manifestations of Gaucher Disease Type 1: Results from Four Completed Clinical Trials
Blood2018-11-29
The Long-Term Adverse Event Profile of Oral Eliglustat for the Treatment of Gaucher Disease Type 1: Pooled Analysis of Data from 393 Patients in 4 Completed Trials
Blood2018-11-29
Outcomes after 8 years of eliglustat therapy for Gaucher disease type 1: Final results from the Phase 2 trial
American Journal of Hematology2018-09-2874 citations
Once- versus twice-daily dosing of eliglustat in adults with Gaucher disease type 1: The Phase 3, randomized, double-blind EDGE trial
Molecular Genetics and Metabolism2018-01-0426 citations
Outcomes after 18 months of eliglustat therapy in treatment‐naïve adults with <scp>G</scp>aucher disease type 1: The phase 3 ENGAGE trial
American Journal of Hematology2017-08-0196 citations
Eliglustat maintains long-term clinical stability in patients with Gaucher disease type 1 stabilized on enzyme therapy
Blood2017-02-0790 citations
Stability is maintained in adults with Gaucher disease type 1 switched from velaglucerase alfa to eliglustat or imiglucerase: A sub-analysis of the eliglustat ENCORE trial
Molecular Genetics and Metabolism Reports2016-10-0218 citations
Long-Term Hematologic Response to Eliglustat in Patients with Gaucher Disease Type 1: Results from a Phase 2 and Two Phase 3 Trials
Blood2015-12-03
Eliglustat compared with imiglucerase in patients with Gaucher's disease type 1 stabilised on enzyme replacement therapy: a phase 3, randomised, open-label, non-inferiority trial.
2015-03-26109 citations
Effect of Oral Eliglustat on Splenomegaly in Patients With Gaucher Disease Type 1
JAMA2015-02-17153 citations
Engage - a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Investigate the Efficacy and Safety of Eliglustat in Adults with Gaucher Disease Type 1: Results after 18 Months
Blood2014-12-065 citations
Encore - a Randomized, Controlled, Open-Label Non-Inferiority Study Comparing Eliglustat to Imiglucerase in Gaucher Disease Type 1 Patients Stabilized on Enzyme Replacement Therapy: 24-Month Results
Blood2014-12-062 citations
Eliglustat, an investigational oral therapy for Gaucher disease type 1: Phase 2 trial results after 4 years of treatment
Blood Cells Molecules and Diseases2014-05-1483 citations
Skeletal improvement in patients with Gaucher disease type 1: a phase 2 trial of oral eliglustat.
2014-05-1044 citations
Encore: A Randomized, Controlled, Open-Label Non-Inferiority Study Comparing Eliglustat To Imiglucerase In Gaucher Disease Type 1 Patients On Enzyme Replacement Therapy Who Have Reached Therapeutic Goals
Blood2013-11-156 citations
Engage: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Study To Investigate The Efficacy and Safety Of Eliglustat In Adults With Gaucher Disease Type 1: 9 Month Results
Blood2013-11-151 citations
Improvement in hematological, visceral, and skeletal manifestations of Gaucher disease type 1 with oral eliglustat tartrate (Genz-112638) treatment: 2-year results of a phase 2 study.
2010-08-1699 citations