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Clinical trials for eliglustat and gaucher disease

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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    4 result(s) found for: eliglustat and gaucher disease. Displaying page 1 of 1.
    EudraCT Number: 2016-000301-37 Sponsor Protocol Number: EFC13738 Start Date*: 2018-10-09
    Sponsor Name:Genzyme Corporation
    Full Title: Open label, Two Cohort (with and without Imiglucerase), Multicenter Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Eliglustat in Pediatric Patients with Gaucher Disease Type 1 and Type 3
    Medical condition: Congenital, hereditary and neonatal diseases
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10075697 Gaucher's disease type I PT
    20.0 10010331 - Congenital, familial and genetic disorders 10075699 Gaucher's disease type III PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) IT (Trial now transitioned) NL (Ongoing) ES (Ongoing) Outside EU/EEA GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2009-015811-42 Sponsor Protocol Number: GZGD03109 Start Date*: 2010-12-20
    Sponsor Name:Genzyme Europe B.V.
    Full Title: A Phase 3, Randomized, Multi-Center, Multi-National, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once Daily versus Twice Daily Dosing of Genz-112638 in Patients wit...
    Medical condition: Gaucher Disease Type I
    Disease: Version SOC Term Classification Code Term Level
    16.0 10010331 - Congenital, familial and genetic disorders 10018048 Gaucher's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed) PT (Completed) AT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2008-005222-37 Sponsor Protocol Number: GZGD02507 Start Date*: 2009-11-04
    Sponsor Name:Genzyme Europe B.V.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Confirming the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1
    Medical condition: Gaucher Disease type I
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10018048 Gaucher's disease PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-005223-28 Sponsor Protocol Number: GZGD02607 Start Date*: 2009-11-04
    Sponsor Name:Genzyme Europe B.V.
    Full Title: A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1 who have Reached ...
    Medical condition: Gaucher Disease type I
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018048 Gaucher's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (Completed) FR (Completed) DE (Completed) ES (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
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    Query did not match any studies.
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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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