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Clinical trials for Agalsidase beta

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   44343   clinical trials with a EudraCT protocol, of which   7372   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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    13 result(s) found for: Agalsidase beta. Displaying page 1 of 1.
    EudraCT Number: 2019-000064-21 Sponsor Protocol Number: LPS15918 Start Date*: Information not available in EudraCT
    Sponsor Name:Sanofi Aventis Groupe (SAG)
    Full Title: A randomized, open-label, active comparator, 2-arm, prospective study to assess the glycosphingolipid clearance and clinical benefits of agalsidase beta (Fabrazyme®) in male patients with classic F...
    Medical condition: Fabry's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: NO (Prematurely Ended) CZ (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-000697-35 Sponsor Protocol Number: AGAL19412 Start Date*: 2015-04-24
    Sponsor Name:Genzyme, a Sanofi Company
    Full Title: Evaluation of Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta (The INFORM Study)
    Medical condition: Fabry Disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000378-38 Sponsor Protocol Number: PB-102-F20 Start Date*: 2016-09-07
    Sponsor Name:Protalix Ltd.
    Full Title: A Randomized, Double blind, Active Control Study of the Safety and Efficacy of PRX-102 compared to Agalsidase Beta on Renal Function in Patients with Fabry Disease Previously Treated With Agalsidas...
    Medical condition: Fabry disease (α-galactosidase A deficiency)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) ES (Completed) CZ (Completed) NO (Completed) BE (Completed) NL (Completed) SI (Completed) IT (Completed) FI (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-000065-20 Sponsor Protocol Number: LPS15919 Start Date*: 2020-02-05
    Sponsor Name:Sanofi Aventis Groupe (SAG)
    Full Title: A randomized, open-label, active comparator, 2-arm, prospective study to assess the glycosphingolipid clearance and clinical effects of switching to agalsidase beta (Fabrazyme®) versus continuing o...
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: NO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-022709-16 Sponsor Protocol Number: AT1001-013 Start Date*: 2011-09-12
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: AN OPEN-LABEL PHASE 2A STUDY TO INVESTIGATE DRUG-DRUG INTERACTIONS BETWEEN AT1001 (MIGALASTAT HYDROCHLORIDE) AND AGALSIDASE IN SUBJECTS WITH FABRY DISEASE
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults Gender: Male
    Trial protocol: BE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-001528-23 Sponsor Protocol Number: PB-102-F50 Start Date*: 2017-10-18
    Sponsor Name:Protalix Ltd.
    Full Title: A Phase 3, Open Label, Switch Over Study to Assess the Safety, Efficacy and Pharmacokinetics of pegunigalsidase alfa (PRX-102) 2 mg/kg Administered by Intravenous Infusion Every 4 Weeks for 52 week...
    Medical condition: Fabry disease (α-galactosidase A deficiency)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) ES (Completed) CZ (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000368-27 Sponsor Protocol Number: MAN-ALG-18-001 Start Date*: 2018-10-22
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: ND
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-001910-33 Sponsor Protocol Number: AGAL02603 Start Date*: 2007-12-05
    Sponsor Name:Genzyme Europe BV
    Full Title: A Multicenter, Multinational Study of the Effects of Fabrazyme® (agalsidase beta) Treatment on Lactation and Infants
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016016 Fabry's disease PT
    Population Age: In utero, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Ongoing)
    Trial results: View results
    EudraCT Number: 2023-000624-11 Sponsor Protocol Number: LPS16583 Start Date*: 2023-06-21
    Sponsor Name:Genzyme Europe B.V.
    Full Title: A Phase 4, open label, safety and efficacy study of Fabrazyme® (agalsidase beta) as enzyme replacement therapy in Chinese participants with Fabry Disease
    Medical condition: Fabry’s disease
    Disease: Version SOC Term Classification Code Term Level
    24.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-005668-28 Sponsor Protocol Number: AGAL06207 Start Date*: 2008-07-29
    Sponsor Name:Genzyme Europe BV
    Full Title: A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symp...
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (Completed) NL (Completed) PT (Prematurely Ended) DE (Prematurely Ended) CZ (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-002320-20 Sponsor Protocol Number: EFC16158 Start Date*: 2022-04-11
    Sponsor Name:sanofi-aventis recherche et développement
    Full Title: A randomized, open-label, parallel-group, 18-month Phase 3 study to evaluate the effect of venglustat compared with usual standard of care on left ventricular mass index in participants with Fabry ...
    Medical condition: Fabry’s disease
    Disease: Version SOC Term Classification Code Term Level
    24.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned) DK (Trial now transitioned) ES (Ongoing) GR (Trial now transitioned) AT (Trial now transitioned) PL (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-022636-37 Sponsor Protocol Number: AT1001-012 Start Date*: 2011-01-18
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOU...
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DK (Completed) AT (Completed) GR (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004689-32 Sponsor Protocol Number: SHP675-301 Start Date*: 2021-09-24
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: A Phase 3, Open-label Study to Evaluate the Efficacy and Safety of REPLAGAL® in Treatment-naïve Subjects with Fabry Disease
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    24.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Prematurely Ended) FI (Prematurely Ended) GR (Prematurely Ended) PL (Prematurely Ended)
    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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