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Clinical trials for Trisomy 8

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    15 result(s) found for: Trisomy 8. Displaying page 1 of 1.
    EudraCT Number: 2008-008342-20 Sponsor Protocol Number: RAA08-015 Start Date*: 2009-02-23
    Sponsor Name:King's College London
    Full Title: Genetically determined brain abnormalities in Down’s Syndrome.- towards a treatment: A randomised, single-blind, placebo-controlled trial of lithium carbonate in Down’s Syndrome (DownsLit).
    Medical condition: Down's Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10013616 Down's syndrome LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-000309-75 Sponsor Protocol Number: Start Date*: 2005-08-26
    Sponsor Name:Christian Geisler, Rigshospitalet, dept. Haematology 4042
    Full Title: HOVON 68 CLL: A randomized phase III study in prevously untreated patients with biological high risk CLL: Fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab.
    Medical condition: Chronic lymphocytic leukaemia (CLL) in biological high-risk group: Unmutated and/or with deletion 17p and/or deletion 11q and/or trisomy 12.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Ongoing) SE (Ongoing) FI (Completed) BE (Ongoing) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002988-25 Sponsor Protocol Number: ML-DS2018 Start Date*: Information not available in EudraCT
    Sponsor Name:Gesellschaft für Pädiatrische Onkologie & Hämatologie (GPOH gGmbH)
    Full Title: Phase III Clinical Trial for CPX-351 in Myeloid Leukemia in Children with Down Syndrome 2018
    Medical condition: Myeloid Leukemia in Children with Down Syndrome
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) NL (Ongoing) AT (Trial now transitioned)
    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 (Ongoing)
    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: 2006-001279-39 Sponsor Protocol Number: CA180-083 Start Date*: 2006-09-15
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase II Study of Dasatinib (BMS-354825) in Subjects with Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia who are Resistant...
    Medical condition: Subjects with Chronic or Advanced Phase Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) who are Resistant or Intolerant to Imatinib.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003426-89 Sponsor Protocol Number: E2020-J081-345 Start Date*: 2018-10-18
    Sponsor Name:Eisai Co., Ltd. (Japan)
    Full Title: A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disable...
    Medical condition: Down syndrome, regression symptoms and disabled activities of daily living
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004946-27 Sponsor Protocol Number: E2020-A001-219 Start Date*: 2017-05-18
    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: 2009-013651-29 Sponsor Protocol Number: AGMT_CLL8/A Start Date*: 2010-01-13
    Sponsor Name:AGMT
    Full Title: MABTENANCE: International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment versus Observation alone in Patients with Chronic Lymphocytic Leukemia
    Medical condition: Chronic Lymphocytic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10009310 CLL LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SK (Completed) CZ (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2006-001853-89 Sponsor Protocol Number: CLI-043 Start Date*: 2006-07-07
    Sponsor Name:Vion Pharmaceuticals, Inc
    Full Title: A phase II study of Cloretazine for elderly patients with de novo poor risk acute myelogenous leukemia.
    Medical condition: Acute Myelogenous Leukemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: (No results available)
    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: 2020-005996-11 Sponsor Protocol Number: MK-1654-007 Start Date*: 2021-08-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for S...
    Medical condition: Prevention of Respiratory syncytial virus (RSV) infection in infants and children at increased risk for severe RSV disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Trial now transitioned) FI (Trial now transitioned) Outside EU/EEA HU (Trial now transitioned) FR (Ongoing) NO (Trial now transitioned) GR (Trial now transitioned) CZ (Trial now transitioned) IT (Ongoing)
    Trial results: (No results available)
    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: 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 (Ongoing) GB (GB - no longer in EU/EEA) FI (Ongoing) ES (Ongoing) FR (Ongoing) DK (Ongoing) NL (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002714-23 Sponsor Protocol Number: LLC1114 Start Date*: 2015-01-07
    Sponsor Name:Fondazione G.I.M.EM.A. Onlus Gruppo Italiano Malattie Ematologiche dell'Adulto
    Full Title: A phase 2 multicenter study to assess the activity and the safety of front-line Ibrutinib plus Rituximab (IR) in unfit patients with Chronic Lymphocytic Leukemia (CLL).
    Medical condition: Chronic Lymphocytic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10024340 Leukemia lymphocytic chronic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    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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