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Clinical trials for givinostat

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   44335   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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    9 result(s) found for: givinostat. Displaying page 1 of 1.
    EudraCT Number: 2017-001629-41 Sponsor Protocol Number: DSC/15/2357/53 Start Date*: 2018-11-15
    Sponsor Name:ITALFARMACO S.P.A.
    Full Title: A randomised, double-blind, placebo-controlled study to evaluate the micro-macroscopic effects on muscles, the safety and tolerability, and the efficacy of givinostat in patients with Becker Muscu...
    Medical condition: Distrofia Muscolare di Becker (DMB)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10059117 Becker's muscular dystrophy PT
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003499-37 Sponsor Protocol Number: DSC/11/2357/44 Start Date*: 2013-01-20
    Sponsor Name:ITALFARMACO
    Full Title: Long-term study evaluating the effect of Givinostat in patients with JAK2V617F positive chronic myeloproliferative neoplasms.
    Medical condition: Chronic myeloproliferative neoplasms (cMPN).
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004851 10028578 Myeloproliferative disorders (excl leukaemias) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) DE (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002566-12 Sponsor Protocol Number: DSC/11/2357/43 Start Date*: 2013-02-04
    Sponsor Name:ITALFARMACO
    Full Title: A Two-Part Study to Assess the Safety and Tolerability, Pharmacokinetics, and Effects on Histology and Different Clinical Parameters of Givinostat in Ambulant Children with Duchenne Muscular Dystrophy
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10028395 Musculoskeletal and connective tissue disorders SOC
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000397-10 Sponsor Protocol Number: DSC/14/2357/51 Start Date*: 2017-07-31
    Sponsor Name:ITALFARMACO S.p.A.
    Full Title: Studio in aperto a lungo termine volto a valutare la sicurezza, la tollerabilità e l'efficacia di GIVINOSTAT in pazienti affetti da distrofia muscolare di Duchenne che sono stati precedentemente tr...
    Medical condition: Distrofia Muscolare di Duchenne (DMD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: IT (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) GB (GB - no longer in EU/EEA) ES (Ongoing) FR (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000401-36 Sponsor Protocol Number: DSC/14/2357/48 Start Date*: 2017-03-07
    Sponsor Name:ITALFARMACO S.p.A.
    Full Title: Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy.
    Medical condition: Duchenne Muscular Dystrophy (DMD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) DE (Completed) NL (Completed) IT (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-000860-27 Sponsor Protocol Number: DSC/12/2357/45 Start Date*: 2013-06-20
    Sponsor Name:ITALFARMACO S.p.A
    Full Title: A two-part study to assess the safety and preliminary efficacy of Givinostat in patients with JAK2V617F positive Polycythemia Vera
    Medical condition: JAK2V617F positive Polycythemia Vera
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10036061 Polycythemia vera LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) FR (Completed) DE (Completed) GB (Completed) PL (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2009-010982-22 Sponsor Protocol Number: DSC/08/2357/38 Start Date*: 2009-04-20
    Sponsor Name:ITALFARMACO
    Full Title: Phase II study of the histone-deacetylase inhibitor GIVINOSTAT (ITF2357) in combination with hydroxyurea in patients with JAK2V617F positive Polycythemia Vera non-responder to hydroxyurea monotherapy
    Medical condition: Polycythemia Vera
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004851 10018847 Haematological disorders HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-019094-15 Sponsor Protocol Number: DSC/08/2357/36 Start Date*: 2010-07-01
    Sponsor Name:Italfarmaco S.p.A.
    Full Title: A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (...
    Medical condition: Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10059176 Juvenile idiopathic arthritis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) ES (Completed) IT (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2011-003341-18 Sponsor Protocol Number: DSC/11/2357/42 Start Date*: 2011-10-14
    Sponsor Name:Italfarmaco S.p.A.
    Full Title: An Open-Label Extension of the Dose Finding study (DSC/08/2357/36) in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
    Medical condition: Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10059176 Juvenile idiopathic arthritis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (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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