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Clinical trials for Trisomy 13

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   44347   clinical trials with a EudraCT protocol, of which   7375   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    6 result(s) found for: Trisomy 13. Displaying page 1 of 1.
    EudraCT Number: 2006-003359-19 Sponsor Protocol Number: GALPED1001 Start Date*: 2007-08-07
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome
    Medical condition: Children with Down syndrom
    Disease: Version SOC Term Classification Code Term Level
    8.1 10013616 Down's syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001936-45 Sponsor Protocol Number: matab4 Start Date*: 2011-05-25
    Sponsor Name:
    Full Title: Pertussis vaccination in pregnancy
    Medical condition: The number of reported pertussis cases is rising, also in very young infants. Different strategies are possible to close the gap of susceptibility between the loss of maternal antibodies and prote...
    Disease:
    Population Age: In utero, Newborns, Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001476-22 Sponsor Protocol Number: 04-30 Start Date*: 2016-02-16
    Sponsor Name:Onconova Therapeutics, Inc.
    Full Title: A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician’s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent
    Medical condition: Myelodysplastic Syndrome
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (GB - no longer in EU/EEA) AT (Prematurely Ended) IE (Prematurely Ended) CZ (Prematurely Ended) FR (Prematurely Ended) HR (Completed) PL (Prematurely Ended) SE (Completed) BE (Prematurely Ended) NL (Prematurely Ended) HU (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004949-92 Sponsor Protocol Number: E2020-A001-336 Start Date*: 2017-03-09
    Sponsor Name:Eisai Inc.
    Full Title: A 10-Week, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride (Aricept) in the Treatment of the Cognitive Dysfunction Exhibited by Children with...
    Medical condition: Down Syndrome, Cognitive Dysfunction
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004948-11 Sponsor Protocol Number: E2020-A001-335 Start Date*: 2017-03-09
    Sponsor Name:Eisai Inc.
    Full Title: A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With D...
    Medical condition: Down Syndrome, Cognitive Dysfunction
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001573-89 Sponsor Protocol Number: D8220C00008 Start Date*: 2019-09-24
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukemia
    Medical condition: Chronic lymphocytic leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008976 Chronic lymphocytic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) GB (GB - no longer in EU/EEA) FI (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) DK (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned)
    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
    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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