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Generated: November 20, 2018

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CLINICAL TRIALS PROFILE FOR CEREZYME

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Clinical Trials for CEREZYME

Trial ID Title Status Sponsor Phase Summary
NCT00364858 Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease Completed Genzyme, a Sanofi Company Phase 4 This is a multicenter, randomized trial to compare the safety and efficacy of two dosing frequencies of Cerezyme® in patients with Gaucher disease who are currently being treated with Cerezyme®. Approximately 90 patients will be randomized in a 2:1 (q4 : q2) ratio to one of two treatment arms at up to 26 study centers worldwide. Patients will continue to receive the same total 4-week dose that they were receiving prior to study enrollment, however, they will be randomized to receive either their total 4-week dose in two infusions, one infusion every 2 weeks or their total 4-week dose in one infusion every 4 weeks. The randomization scheme will ensure a 2:1 balance between the every 4-week versus every 2-week infusion groups, respectively.
NCT00365131 A Multicenter Study of the Efficacy of Cerezyme in Testing Skeletal Disease in Patients With Type I Gaucher Disease. Completed Genzyme, a Sanofi Company Phase 4 This is a multicenter, open-label, prospective study of the efficacy of Cerezyme in treating patients with skeletal manifestations secondary to Type I Gaucher disease. The study objective is to evaluate and quantify skeletal responses as compared to baseline in Type I gaucher disease patients receiving Cerezyme therapy for 48 months. Additional objectives were to assess the usefulness of various skeletal parameters, such as bone pain, bone crises, bone mineral density, and serum and urine bone markers, as indicative of treatment response and may be useful in dose management.
NCT00712348 Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase Completed Protalix Phase 3 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.
NCT01136304 Validating a New Severity Score System for Adults With Type 1 Gaucher Disease (GD1) Completed University of Pittsburgh N/A 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.
NCT01136304 Validating a New Severity Score System for Adults With Type 1 Gaucher Disease (GD1) Completed University Research Foundation for Lysosomal Storage Diseases, Inc. N/A 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.
NCT01161914 The Safety and Efficacy Study of ISU302 in Patient With Type I Gaucher Disease Withdrawn ISU Abxis Co., Ltd. Phase 3 The purpose of this study is to compare and evaluate the efficacy and safety of ISU302, an investigational product, and Cerezyme®, comparator, for Type 1 Gaucher Disease patients
NCT02843035 GZ/SAR402671 in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 Recruiting Genzyme, a Sanofi Company Phase 2 Primary Objective: Part 1: - Evaluate central nervous system (CNS) biomarkers in adult Gaucher disease (GD) type 3 (GD3) patients that distinguish GD3 from Gaucher disease type 1 (GD1). - Screen adult GD3 patients who qualify for treatment with GZ/SAR402671 in Part 2. Part 2: - Evaluate the safety and tolerability of GZ/SAR402671 in adult GD3 patients. - Evaluate the change in cerebrospinal fluid (CSF) central nervous system (CNS) biomarkers from adult GD3 patients receiving GZ/SAR402671. Secondary Objectives: - Evaluate the pharmacokinetics of GZ/SAR402671 in adult GD3 patients. - Explore the efficacy of GZ/SAR402671 in infiltrative lung disease (IDL) in adult GD3 patients. - Explore the efficacy of GZ/SAR402671 in systemic disease in adult GD3 patients. - Explore the efficacy of GZ/SAR402671 in neurological function and on exploratory CSF biomarkers in adult GD3 patients.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for CEREZYME

Condition Name

Condition Name for CEREZYME
Intervention Trials
Gaucher Disease 4
Cerebroside Lipidosis Syndrome 2
Gaucher Disease, Non-Neuronopathic Form 2
Glucosylceramide Beta-Glucosidase Deficiency Disease 2
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Condition MeSH

Condition MeSH for CEREZYME
Intervention Trials
Gaucher Disease 8
Deficiency Diseases 2
Lipidoses 2
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Clinical Trial Locations for CEREZYME

Trials by Country

Trials by Country for CEREZYME
Location Trials
United States 19
United Kingdom 3
Canada 3
Spain 2
Italy 2
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Trials by US State

Trials by US State for CEREZYME
Location Trials
Florida 4
New York 2
Georgia 2
Oregon 1
Ohio 1
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Clinical Trial Progress for CEREZYME

Clinical Trial Phase

Clinical Trial Phase for CEREZYME
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for CEREZYME
Clinical Trial Phase Trials
Completed 4
Recruiting 2
Withdrawn 1
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Clinical Trial Sponsors for CEREZYME

Sponsor Name

Sponsor Name for CEREZYME
Sponsor Trials
Genzyme, a Sanofi Company 3
Sanofi 2
Protalix 1
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Sponsor Type

Sponsor Type for CEREZYME
Sponsor Trials
Industry 7
Other 3
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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
QuintilesIMS
Colorcon
Teva
Daiichi Sankyo
US Army
Accenture
Fuji
Medtronic

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