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Clinical trials for Glucosidase II

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
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    The EU Clinical Trials Register currently displays   44344   clinical trials with a EudraCT protocol, of which   7373   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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    95 result(s) found for: Glucosidase II. Displaying page 2 of 5.
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    EudraCT Number: 2010-023561-22 Sponsor Protocol Number: POM-001 Start Date*: 2011-08-15
    Sponsor Name:BioMarin Pharmaceutical Inc
    Full Title: A Phase 1/2 Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic and Preliminary Efficacy of BMN 701 (GILT-tagged Recombinant human GAA) in Patients with Late-onset Pompe...
    Medical condition: Pompe disease
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10036143 Pompe's disease LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) 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 (Completed) 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: 2019-003595-38 Sponsor Protocol Number: AT845-01 Start Date*: 2020-11-20
    Sponsor Name:Audentes Therapeutics, Inc.
    Full Title: FORTIS: A Phase 1/2, Open-Label, Ascending-Dose Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT845, an AAV8-Delivered Gene Transfer Therapy in Patients with Late Onset Pompe Di...
    Medical condition: Late 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: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-003475-21 Sponsor Protocol Number: ACT14132 Start Date*: 2017-05-17
    Sponsor Name:Genzyme Corporation
    Full Title: An Open-label Ascending Dose Cohort Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of Avalglucosidase Alfa (NeoGAA, GZ402666) in Patients with Infantile-onset Pompe Disease ...
    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: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Ongoing) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-004686-39 Sponsor Protocol Number: EFC14462 Start Date*: Information not available in EudraCT
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: An Open-label, Multinational, Multicenter, Intravenous Infusion Study of the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of avalglucosidase alfa in Treatment naïve Pediatric Participan...
    Medical condition: Glycogen storage disease type II
    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: DE (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) Outside EU/EEA ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-002590-26 Sponsor Protocol Number: PTA17333 Start Date*: Information not available in EudraCT
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: A French multicenter Phase 4 open label extension study of long term safety and efficacy in patients with Pompe disease who previously participated in avalglucosidase development studies in France
    Medical condition: Glycogen storage disease type II
    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: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-000582-31 Sponsor Protocol Number: AGLU3306 Start Date*: 2015-04-15
    Sponsor Name:Genzyme Corporation Inc
    Full Title: An Exploratory, Open-Label Study of the Safety and Efficacy of High Dose or High Dosing Frequency Myozyme® (alglucosidase alfa) Treatment in Patients with Pompe Disease Who Do Not Have an Optimal R...
    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 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004798-34 Sponsor Protocol Number: ATB200-02 Start Date*: 2016-08-01
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: AN OPEN-LABEL, FIXED-SEQUENCE, ASCENDING-DOSE, FIRST-IN-HUMAN STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF INTRAVENOUS INFUSIONS OF ATB200 CO-ADMINI...
    Medical condition: Pompe Disease - acid maltase deficiency or glycogen storage disease type II.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036143 Pompe's disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001283-30 Sponsor Protocol Number: SPK-3006-101 Start Date*: 2020-06-16
    Sponsor Name:Spark Therapeutics
    Full Title: Phase 1/2, dose-escalation study to evaluate the safety, tolerability and efficacy of a single intravenous infusion of SPK-3006 in adults with late-onset Pompe disease
    Medical condition: Pompe Disease (also known as glycogen storage disease type II)
    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: Adults Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) DE (Trial now transitioned) NL (Ongoing) DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-001375-11 Sponsor Protocol Number: not applicable Start Date*: 2007-05-16
    Sponsor Name:
    Full Title: Effects and health economic aspects of enzyme therapy in children and adults with Pompe disease Long-term follow-up of patients receiving commercially available Myozyme
    Medical condition: Pompe disease (glycogen storage disease type II) is a genetic, lysosomal storage disorder with a frequency of 1 in 40.000 newborns. The disease is caused by deficiency of alpha-glucosidase, a lysos...
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-005825-12 Sponsor Protocol Number: PB-06-002 Start Date*: 2009-06-04
    Sponsor Name:Protalix Biotherapeutics
    Full Title: Ensayo clinico de fase 3, multicéntrico, en abierto y con cambio de tratamiento para evaluar la seguridad y eficacia de Glucocerebrosidasa Humana Recombinante expresada en células vegetales (prGCD)...
    Medical condition: Enfermedad de Gaucher Gaucher Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018048 Gaucher's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) IT (Completed) DE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-002829-31 Sponsor Protocol Number: AGLU02804, Amendment 1 Start Date*: 2005-08-31
    Sponsor Name:Genzyme Europe BV
    Full Title: Full title of the trial : A Single Centre, Open-Label, Bridging Study of the Safety, Pharmacokinetics and Efficacy of Recombinant Human Acid Alpha-Glucosidase (rhGAA) Treatment in Patients with Lat...
    Medical condition: Glycogen Storage Disease type II (Pompe´s disease)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000904-88 Sponsor Protocol Number: 1218.149 Start Date*: 2014-08-05
    Sponsor Name:Boehringer Ingelheim Ellas SA
    Full Title: A 24 week randomized, double-blind, placebo-controlled, parallel group, efficacy and safety trial of once daily linagliptin, 5 milligrams orally, as add on to basal insulin in elderly Type 2 Diabet...
    Medical condition: Type 2 Diabetes Mellitus
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GR (Completed) ES (Completed) DK (Completed) GB (Completed) FI (Completed) DE (Completed) BE (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2009-011399-31 Sponsor Protocol Number: NN1250-3718 Start Date*: 2009-12-21
    Sponsor Name:Novo Nordisk A/S
    Full Title: BEGIN™: EASY PM A trial comparing the efficacy and safety of NN1250 and insulin glargine in subjects with type 2 diabetes
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    12.0 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) HU (Completed) FR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2004-001461-18 Sponsor Protocol Number: NN304-1632 Start Date*: 2004-12-06
    Sponsor Name:NOVO NORDISK
    Full Title: A 20 week multi-national, open-labelled, randomised, three-group parallel trial comparing administration of insulin detemir morning, insulin detemir evening and NPH insulin evening as add-on to ora...
    Medical condition: Combined therapy in diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    6.1 10012601 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-005776-27 Sponsor Protocol Number: NN1250-3579 Start Date*: 2009-07-27
    Sponsor Name:Novo Nordisk A/S
    Full Title: A 52-week randomised, controlled, open label, multicentre, multinational treat-to-target trial comparing the efficacy and safety of SIBA and insulin glargine, both injected once daily in combinatio...
    Medical condition: Type 2 diabetes
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) FI (Completed) FR (Completed) AT (Completed) ES (Completed) DK (Completed) SI (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2006-006754-10 Sponsor Protocol Number: CL3-05702-014 Start Date*: 2007-03-14
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: Efficacy and safety of gliclazide MR (30 to 120 mg per day) associated or not to metformine or to an α-glucosidase inhibitor during the fast of the Ramadan in type 2 diabetic patients. A 5 to 8 mon...
    Medical condition: Diabetes mellitus non insulino dependant
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027433 Metabolism and nutrition disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2009-011106-42 Sponsor Protocol Number: 2008MZ09B Start Date*: 2009-06-25
    Sponsor Name:Institute for Clinical and Experimental Medicine
    Full Title: Aditive effects of omega-3 polyunsaturated fatty acids and pioglitazone in the treatment of type 2 diabetes mellitus
    Medical condition: The project deals with hummoral and metabolic aspects of insulin resistance (IR), which is assumed to be the basic metabolic disorder which leads to the development of type 2 diabetes mellitus (T2D...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-009889-13 Sponsor Protocol Number: CACZ885I2202 Start Date*: 2009-08-20
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration for the Treatment of Hyperglycemia in Metformin Monotherapy Treated Type 2 Diabetic Patients: a Randomized, Doub...
    Medical condition: Type II Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012601 Diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) HU (Prematurely Ended) DE (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2007-003430-42 Sponsor Protocol Number: MKC-253-002 Start Date*: 2008-01-15
    Sponsor Name:MannKind Corporation
    Full Title: A Phase 1, Repeated Single-Dose, Double Blind, Randomized Five Treatment Controlled Safety and Pharmacological Response Evaluation Trial of MKC253 Inhalation Powder in Adult Male and Postmenopausal...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
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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
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