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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR ELIGLUSTAT TARTRATE

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Clinical Trials for Eliglustat Tartrate

Trial ID Title Status Sponsor Phase Summary
NCT00358150 A Study of the Efficacy and Safety of Eliglustat Tartrate (Genz-112638) in Type 1 Gaucher Patients Completed Genzyme, a Sanofi Company Phase 2 Gaucher disease is a genetic disease that results in a deficiency of an enzyme acid beta-glucosidase, also known as glucocerebrosidase. This enzyme is needed to digest a substrate (lipid) called glucosylceramide and, to a lesser degree, glucosylsphingosine. In participants with Gaucher disease, the liver, spleen, bone marrow and brain show increases in lipid concentration, specifically in cells derived from the monocyte/macrophage system. Eliglustat tartrate (Genz-112638) is an oral drug that may regulate the Gaucher disease process by decreasing the synthesis of glucosylceramide. The primary objective of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of eliglustat tartrate, administered as an oral dose of either 50 milligram (mg) twice daily (BID) or 100 mg BID, to men and women with Gaucher disease Type 1 for 52 weeks.
NCT00891202 A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease (ENGAGE) Completed Genzyme, a Sanofi Company Phase 3 This Phase 3 study is designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease Type 1.
NCT00943111 A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE) Completed Genzyme, a Sanofi Company Phase 3 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).
NCT01074944 A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE) Completed Genzyme, a Sanofi Company Phase 3 The primary objective of this study was to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638). The secondary objective was to evaluate the pharmacokinetics (PK) of Genz-99067 when eliglustat tartrate (Genz-112638) was administered QD and BID in participants with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638).
NCT02536911 A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate Recruiting Genzyme, a Sanofi Company Phase 1 Primary Objective: To study the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of eliglustat. Secondary Objective: To assess the tolerability of eliglustat tartrate given as a single dose in subjects with mild and moderate hepatic impairment in comparison with matched subjects with normal hepatic function.
NCT02536937 A Study of the Effects of Renal Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate Recruiting Sanofi Phase 1 Primary Objective: To study the effect of mild, moderate, and severe renal impairment on the pharmacokinetics (PK) of eliglustat. Secondary Objective: To assess the tolerability of eliglustat tartrate given as a single dose in subjects with mild, moderate, and severe renal impairment in comparison with matched subjects with normal renal function.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Eliglustat Tartrate

Condition Name

Condition Name for Eliglustat Tartrate
Intervention Trials
Gaucher Disease, Type 1 3
Gaucher Disease 3
Gaucher Disease, Non-Neuronopathic Form 1
Cerebroside Lipidosis Syndrome 1
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Condition MeSH

Condition MeSH for Eliglustat Tartrate
Intervention Trials
Gaucher Disease 6
Renal Insufficiency 1
Lipidoses 1
Deficiency Diseases 1
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Clinical Trial Locations for Eliglustat Tartrate

Trials by Country

Trials by Country for Eliglustat Tartrate
Location Trials
United States 35
Russian Federation 4
Canada 3
Israel 2
Australia 2
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Trials by US State

Trials by US State for Eliglustat Tartrate
Location Trials
New York 4
Florida 3
Virginia 3
Georgia 3
Connecticut 3
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Clinical Trial Progress for Eliglustat Tartrate

Clinical Trial Phase

Clinical Trial Phase for Eliglustat Tartrate
Clinical Trial Phase Trials
Phase 3 3
Phase 2 1
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Eliglustat Tartrate
Clinical Trial Phase Trials
Completed 4
Recruiting 2
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Clinical Trial Sponsors for Eliglustat Tartrate

Sponsor Name

Sponsor Name for Eliglustat Tartrate
Sponsor Trials
Genzyme, a Sanofi Company 5
Sanofi 1
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Sponsor Type

Sponsor Type for Eliglustat Tartrate
Sponsor Trials
Industry 6
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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Julphar
Argus Health
Queensland Health
Johnson and Johnson
Farmers Insurance
Baxter
McKesson
Fuji

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