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Last Updated: December 14, 2019

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CLINICAL TRIALS PROFILE FOR ALGLUCOSIDASE ALFA

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All Clinical Trials for alglucosidase alfa

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00158600 A Placebo-Controlled Study of Safety and Effectiveness of Myozyme (Alglucosidase Alfa) in Patients With Late-Onset Pompe Disease Completed Genzyme, a Sanofi Company Phase 3 2005-09-01 Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective is to evaluate the safety, efficacy, and pharmacokinetics (PK) of alglucosidase alfa treatment in patients with late-onset Pompe disease as compared to placebo.
NCT00701129 An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-naive Cross-Reacting Immunologic Material (CRIM[-]) Patients With Infantile-Onset Pompe Disease Completed Genzyme, a Sanofi Company Phase 4 2009-10-01 The purpose of this study was to evaluate the efficacy, clinical benefits and safety of a prophylactic immunomodulatory regimen given prior to first treatment with alglucosidase alfa (Myozyme®) in patients with infantile-onset Pompe disease. The objectives were to assess the efficacy of a prophylactic immunomodulatory regimen given prior to first treatment with alglucosidase alfa, as assessed by anti-recombinant human acid alpha-glucosidase (anti-rhGAA) antibody titers, and antibodies that inhibit the activity and/or uptake of alglucosidase alfa; to evaluate the clinical benefit as measured by overall survival, ventilator-free survival, left ventricular mass index (LVMI), gross motor function and development, disability index and the incidence of adverse events (AEs), serious adverse events (SAEs), and clinical laboratory abnormalities.
NCT01380743 Drug-drug Interaction Study Completed Amicus Therapeutics Phase 2 2011-10-01 This study will look at Drug-Drug Interactions Between AT2220 (duvoglustat hydrochloride) and alglucosidase alfa (ERT) in Patients with Pompe Disease.
NCT01526785 A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease Terminated Genzyme, a Sanofi Company Phase 4 2012-03-01 The objective of this study was to evaluate the efficacy and safety of treatment with 4000 litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.
NCT01898364 Safety and Efficacy Evaluation of Repeat neoGAA Dosing in Late Onset Pompe Disease Patients. Completed Genzyme, a Sanofi Company Phase 1 2013-07-01 Primary Objective: To evaluate the safety and tolerability of neoGAA in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients. Secondary Objective: To evaluate the pharmacokinetics, pharmacodynamics of neoGAA in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients. To evaluate the effect of neoGAA on exploratory efficacy endpoints in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients.
NCT02782741 Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies neoGAA and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease Recruiting Sanofi Phase 3 2016-10-01 Primary Objective: To determine the effect of neoGAA (GZ402666) treatment on respiratory muscle strength measured by percent predicted forced vital capacity (% FVC) in the upright position, as compared to alglucosidase alfa. Secondary Objective: To determine the safety and effect of neoGAA treatment on functional endurance (6-minute walk test (6MWT), inspiratory muscle strength (maximum inspiratory pressure (MIP)), expiratory muscle strength (maximum expiratory pressure (MEP)), lower extremity muscle strength (hand-held dynamometry (HHD)), motor function (Quick Motor Function Test (QMFT)), and health-related quality of life (SF-12).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for alglucosidase alfa

Condition Name

Condition Name for alglucosidase alfa
Intervention Trials
Pompe Disease 5
Pompe Disease (Late-onset) 3
Glycogen Storage Disease Type II-Pompe's Disease 2
Glycogen Storage Disease Type II 2
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Condition MeSH

Condition MeSH for alglucosidase alfa
Intervention Trials
Glycogen Storage Disease Type II 11
Glycogen Storage Disease 6
Deficiency Diseases 1
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Clinical Trial Locations for alglucosidase alfa

Trials by Country

Trials by Country for alglucosidase alfa
Location Trials
United States 62
France 4
United Kingdom 4
Netherlands 3
Germany 2
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Trials by US State

Trials by US State for alglucosidase alfa
Location Trials
North Carolina 5
California 5
Arizona 4
Virginia 4
Ohio 3
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Clinical Trial Progress for alglucosidase alfa

Clinical Trial Phase

Clinical Trial Phase for alglucosidase alfa
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for alglucosidase alfa
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 4
Recruiting 2
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Clinical Trial Sponsors for alglucosidase alfa

Sponsor Name

Sponsor Name for alglucosidase alfa
Sponsor Trials
Genzyme, a Sanofi Company 7
Amicus Therapeutics 3
Sanofi 1
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Sponsor Type

Sponsor Type for alglucosidase alfa
Sponsor Trials
Industry 11
Other 1
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