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Last Updated: November 14, 2019

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CLINICAL TRIALS PROFILE FOR IMIGLUCERASE

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All Clinical Trials for Imiglucerase

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00712348 Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase Completed Protalix Phase 3 2008-12-01 This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy.
NCT00875160 A Study in Type 1 Gaucher Patients to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of AT2101 Terminated Amicus Therapeutics Phase 1 2009-04-01 This is an open-label study designed to assess if AT2101 is safe in patients with Gaucher disease and how AT2101 gets through the body after it is taken by mouth. The study is being offered to adult patients with type 1 Gaucher disease who are currently receiving a stable dose of enzyme replacement therapy (ERT) with imiglucerase. During the study, subjects will not be receiving ERT (up to 35 days). The study consists of a screening period (~14 days), a treatment period (12 days) and a follow-up period (7 days after last dose). At two points in the study, subjects will be housed in an in-patient treatment facility for 3 days/2 nights to accommodate all necessary blood draws.
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 2009-09-01 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).
NCT00954460 Treatment Protocol of Velaglucerase Alfa for Patients With Type 1 Gaucher Disease Approved for marketing Shire N/A 1969-12-31 Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. The purpose of this treatment protocol is to observe the safety of velaglucerase alfa in patients with type 1 Gaucher disease who are either treatment naive (newly diagnosed) or who are currently being treated with the Enzyme Replacement Therapy (ERT) imiglucerase.
NCT00962260 Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease No longer available Protalix N/A 1969-12-31 This is an open-label expanded access trial of prGCD in patients with Gaucher disease who require enzyme replacement therapy (ERT) and who have been treated with imiglucerase but for whom the dose has been reduced or discontinued due to shortage of the product.
NCT01136304 Validating a New Severity Score System for Adults With Type 1 Gaucher Disease (GD1) Completed University of Pittsburgh N/A 2010-04-01 With the participation of an international consortium of investigators, the investigators will evaluate the validity of a new severity score system called DS3 for adult patients with Gaucher disease. The investigators hypothesize that initial DS3 scores will be predictive of both disease progression and patterns of response including imiglucerase dose sensitivity and completeness and maintenance of response and that sequential DS3 scores will accurately portray either clinical progression of disease or improvement in response to treatment. The investigators will also collect DNA specimens that in future research will be used in conjunction with the DS3 scores to evaluate determinants of the clinical course and the response to treatments for Gaucher disease.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Imiglucerase

Condition Name

Condition Name for Imiglucerase
Intervention Trials
Gaucher Disease 7
Gaucher Disease, Type 1 3
Type 1 Gaucher Disease 1
Gaucher's Disease Type III 1
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Condition MeSH

Condition MeSH for Imiglucerase
Intervention Trials
Gaucher Disease 12
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Clinical Trial Locations for Imiglucerase

Trials by Country

Trials by Country for Imiglucerase
Location Trials
United States 51
United Kingdom 4
Canada 3
Israel 3
France 2
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Trials by US State

Trials by US State for Imiglucerase
Location Trials
Florida 6
New York 4
Georgia 4
California 4
Virginia 3
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Clinical Trial Progress for Imiglucerase

Clinical Trial Phase

Clinical Trial Phase for Imiglucerase
Clinical Trial Phase Trials
Phase 3 6
Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Imiglucerase
Clinical Trial Phase Trials
Completed 5
Recruiting 2
Approved for marketing 1
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Clinical Trial Sponsors for Imiglucerase

Sponsor Name

Sponsor Name for Imiglucerase
Sponsor Trials
Protalix 3
Genzyme, a Sanofi Company 2
ISU Abxis Co., Ltd. 2
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Sponsor Type

Sponsor Type for Imiglucerase
Sponsor Trials
Industry 10
Other 3
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