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Clinical trials for Alpha Glucosidase

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    83 result(s) found for: Alpha Glucosidase. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2013-003321-28 Sponsor Protocol Number: LTS13769 Start Date*: 2014-05-12
    Sponsor Name:Genzyme Corporation
    Full Title: An Open-Label, Multicenter, Multinational Extension Study Of The Long-Term Safety And Pharmacokinetics Of Repeated Biweekly Infusions Of Avalglucosidase Alfa (NeoGAA, GZ402666) In Patients With Pom...
    Medical condition: Pompe disease (acid alpha-glucosidase deficiency)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10036143 Pompe's disease LLT
    20.1 10010331 - Congenital, familial and genetic disorders 10053185 Glycogen storage disease type II PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed) DK (Completed) DE (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2008-002302-18 Sponsor Protocol Number: POM-CL-201 Start Date*: 2009-02-16
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: An open-label, multicenter, study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of three dosing regimens of oral AT2220 in patients with Pompe disease
    Medical condition: Pompe Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036143 Pompe's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-000512-18 Sponsor Protocol Number: AGLU09411/EFC12720 Start Date*: 2015-03-02
    Sponsor Name:Genzyme Corporation Inc
    Full Title: A Phase 4 Open Label, Prospective Study in Patients With Pompe Disease to Evaluate The Efficacy and Safety of Alglucosidase Alfa Produced at the 4000L Scale
    Medical condition: Pompe disease (acid alpha-glucosidase deficiency)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10036143 Pompe's disease LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-008293-31 Sponsor Protocol Number: Pompe phys 03 Start Date*: 2009-02-10
    Sponsor Name:Erasmus MC Sophia
    Full Title: Early introduction in the Netherlands of alglucosidase alfa manufactured in a 4000 liter bioreactor
    Medical condition: Glycogen Storage Disease Type II (Pompe's Disease)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036143 Pompe's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002251-42 Sponsor Protocol Number: GZ-2016-11512. Start Date*: Information not available in EudraCT
    Sponsor Name:
    Full Title: An open-label, single-center study on the safety and efficacy of avalglucosidase alpha in late-onset Pompe patients ≥5 years
    Medical condition: Late onset Pompe disease
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004850 10036143 Pompe's disease LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-024647-32 Sponsor Protocol Number: MIGLU-3 Start Date*: 2011-03-18
    Sponsor Name:UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II
    Full Title: Combined enzyme enhancement therapy (EET) and enzyme replacement therapy (ERT) in patients with Pompe disease
    Medical condition: Patients with Pompe Disease (Type II Glycogenosis) on therapy with Enzyme Replacement Therapy (ERT) for at least 6 months
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10036143 Pompe's disease LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-002154-32 Sponsor Protocol Number: AT2220-010 Start Date*: 2011-12-07
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: AN OPEN-LABEL MULTI-CENTER, INTERNATIONAL STUDY TO INVESTIGATE DRUG-DRUG INTERACTIONS BETWEEN AT2220 AND ALGLUCOSIDASE ALFA IN PATIENTS WITH POMPE DISEASE
    Medical condition: Pompe Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10036143 Pompe's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-002158-38 Sponsor Protocol Number: 701-201 Start Date*: 2015-03-23
    Sponsor Name:BioMarin Pharmaceutical Inc
    Full Title: A Study of Respiratory Muscle Strength, including Effort-Independent Measures, in Subjects with Late-Onset Pompe Disease
    Medical condition: Pompe disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10036143 Pompe's disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000584-14 Sponsor Protocol Number: AGLU03807,MSC12862 Start Date*: 2015-04-15
    Sponsor Name:Genzyme Corporation Inc
    Full Title: An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-naïve CRIM(-) Patients with Infantile-Onset Pompe Disease
    Medical condition: Pompe disease (acid alpha-glucosidase deficiency)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10036143 Pompe's disease LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-003644-31 Sponsor Protocol Number: AGLU03206 Start Date*: 2007-01-18
    Sponsor Name:Genzyme Europe BV
    Full Title: An Open-Label Extension Study of Patients with Late-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU02704
    Medical condition: Glycogen Storage Disease type II (Pompe's disease)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-000583-34 Sponsor Protocol Number: AGLU03707_MSC12817 Start Date*: 2015-04-15
    Sponsor Name:Genzyme Corporation Inc
    Full Title: An Exploratory Study of the Safety and Efficacy of Immune Tolerance Induction (ITI) in Patients with Pompe Disease Who Have Previously Received Myozyme
    Medical condition: Pompe disease (acid alpha-glucosidase deficiency)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10036143 Pompe's disease LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-022231-11 Sponsor Protocol Number: AGLU07710 Start Date*: 2012-12-13
    Sponsor Name:Genzyme Corporation
    Full Title: A Phase 3/4 Prospective Study to Characterize the Pharmacokinetics of Alglucosidase Alfa in Patients Aged 8 Years of Age and Older
    Medical condition: Pompe disease (acid alpha-glucosidase deficiency)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10036143 Pompe's disease LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2021-004047-25 Sponsor Protocol Number: ALGMYL08718 Start Date*: 2021-07-27
    Sponsor Name:Sanofi(China) Investment Co Ltd, Shanghai Branch
    Full Title: A Single Arm, Prospective, Open-label, Multi-center Study to Evaluate Efficacy and Safety in Chinese Patients with Infantile-Onset Pompe Disease with One Year Alglucosidase Alfa Treatment
    Medical condition: Infantile-Onset Pompe Disease
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10053185 Glycogen storage disease type II PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-001768-48 Sponsor Protocol Number: 701-301 Start Date*: 2013-11-27
    Sponsor Name:BioMarin Pharmaceutical Inc
    Full Title: A Phase 3 Switchover Study of the Efficacy and Safety of BMN 701 (GILT-tagged Recombinant Human GAA) and Long-Term Study for Extended Treatment in rhGAA Exposed Subjects with Late-onset Pompe Disease
    Medical condition: Pompe disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10036143 Pompe's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) BE (Prematurely Ended) DE (Prematurely Ended) IT (Completed) PT (Prematurely Ended) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-005595-42 Sponsor Protocol Number: AGLU07510 Start Date*: 2013-04-17
    Sponsor Name:Genzyme Corporation, a Sanofi company
    Full Title: A Phase 3/4, Prospective, Multinational, Open-label, Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients with Infantile-Onset Pompe Di...
    Medical condition: Pompe disease (acid alpha-glucosidase deficiency)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10036143 Pompe's disease LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-020611-36 Sponsor Protocol Number: AGLU07310 Start Date*: 2011-10-12
    Sponsor Name:Genzyme Europe B.V.
    Full Title: A Phase 4 Prospective Exploratory Muscle Biopsy, Biomarker, and Imaging Assessment Study in Patients With Late-Onset Pompe Disease Treated With Alglucosidase Alfa
    Medical condition: Pompe disease (acid alpha-glucosidase deficiency)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10036143 Pompe's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2004-002168-59 Sponsor Protocol Number: AGLU017-02 Start Date*: 2004-10-14
    Sponsor Name:GENZYME
    Full Title: An Open-Label, Multicenter, Multinational, Study of the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Acid alpha- Glucosidase (rhGAA) Treatment in Patients > 6 and <...
    Medical condition: Treatment for Type II Glycogenosis
    Disease: Version SOC Term Classification Code Term Level
    6.1 10053185 PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-002759-42 Sponsor Protocol Number: AGLU02704 Start Date*: 2007-07-18
    Sponsor Name:Genzyme Europe BV
    Full Title: A Randomized, Double-Blind, Multicenter, Multinational, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Myozyme, Recombinant Human Acid alpha-Glucosidase (rhGAA), Treatmen...
    Medical condition: Glycogen Storage Disease type II (Pompe's disease)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036143 Pompe's disease LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-000942-77 Sponsor Protocol Number: EFC14028 Start Date*: 2016-07-15
    Sponsor Name:Genzyme Corporation
    Full Title: A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of Avalglucosidase Alfa (neoGAA, GZ402666) and Alglucosidase ...
    Medical condition: Pompe disease (acid alpha-glucosidase deficiency)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036143 Pompe's disease LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Prematurely Ended) SE (Prematurely Ended) NL (Completed) ES (Ongoing) CZ (Completed) DE (Completed) BE (Completed) AT (Completed) PL (Completed) IT (Completed) PT (Completed) BG (Completed) HU (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-001805-28 Sponsor Protocol Number: POM-002 Start Date*: 2012-07-03
    Sponsor Name:BioMarin Pharmaceutical Inc
    Full Title: A Long-Term Study for Extended BMN 701Treatment of Patients with Pompe Disease who have Participated in a BMN 701 Study
    Medical condition: Pompe disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10036143 Pompe's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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