Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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   43865   clinical trials with a EudraCT protocol, of which   7286   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children

    Summary
    EudraCT number
    		 2015-001776-21
    Trial protocol
    		 AT   NL  
    Global end of trial date
    31 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Oct 2023
    First version publication date
    08 Oct 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NCT00687882
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00687882
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Kids-DOTT: KidsDOTT
    Sponsors
    Sponsor organisation name
    Medizinische Universität Wien
    Sponsor organisation address
    Spitalgasse 23, Wien, Austria, 1090
    Public contact
    Univ. Prof. Dr. , M.Sc Christoph Male, Medizinische Universität Wien, Universitätsklinik für Kinder- und Jugendheilkunde, 0043 14040021100, christoph.male@meduniwien.ac.at
    Scientific contact
    Univ. Prof. Dr. , M.Sc Christoph Male, Medizinische Universität Wien, Universitätsklinik für Kinder- und Jugendheilkunde, 0043 14040021100, christoph.male@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of shortened-duration (6 weeks total) versus conventional-duration (3 months total) anticoagulation for first-episode, provoked, acute venous thrombosis among children in whom thrombus resolution/non-occlusion (i.e. established blood flow) is evident after the initial 6 weeks of anticoagulant therapy Hypothesis: Among children with first-episode, provoked, acute venous thrombosis in whom thrombosis is resolved or non-occlusive at six weeks follow-up, a shortened duration of anticoagulation (total six weeks; i.e. no further therapy) is non-inferior in efficacy to the conventional duration (total three months) of anticoagulation with respect to the risk of symptomatic recurrent VTE at 1 year, and is superior in safety with respect to the risk of clinically-relevant bleeding.(The hypothesis will also be tested in secondary analysis at 2 years, using the same efficacy and safety outcomes as for the 1 year primary analysis.)
    Protection of trial subjects
    yes
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    1
    Children (2-11 years)
    2
    Adolescents (12-17 years)
    3
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Children (birth to < 21a) with acute deep venous thrombosis in the past 30 days

    Pre-assignment
    Screening details
    		 children with provoked event (central venous line, infection,dehydration, surgery, trauma...)

    Period 1
    Period 1 title
    baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Duration of anticoagulant therapy
    Arm description
    		 duration (6 or 12 weeks total)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Marcoumar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    depending on patients INR value

    Investigational medicinal product name
    Lovenox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    depending on patients anti Xa value

    Number of subjects in period 1
    		Duration of anticoagulant therapy
    Started
    6
    Completed
    5
    Not completed
    1
         Adverse event, serious fatal
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Duration of anticoagulant therapy
    Reporting group description
    		 duration (6 or 12 weeks total)

    Reporting group values
    		 Duration of anticoagulant therapy Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 1 1
        Infants and toddlers (28 days-23 months)
    		 2 2
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 3 3
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 4 4
    Subject analysis sets

    Subject analysis set title
    Marcoumar
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    6 weeks duration of anticoagulant thearpy

    Subject analysis set title
    Marcoumar
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    12 weeks duration of anticoagulant therapy

    Subject analysis set title
    Lovenox
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    duration of anticoagulant therapy 6 weeks

    Subject analysis sets values
    		 Marcoumar Marcoumar Lovenox
    Number of subjects
    5
    3
    1
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    1
        Infants and toddlers (28 days-23 months)
    2
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    3
    3
    0
        Adults (18-64 years)
    0
    0
    0
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    2
    2
    0
        Male
    3
    1
    1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Duration of anticoagulant therapy
    Reporting group description
    		 duration (6 or 12 weeks total)

    Subject analysis set title
    Marcoumar
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    6 weeks duration of anticoagulant thearpy

    Subject analysis set title
    Marcoumar
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    12 weeks duration of anticoagulant therapy

    Subject analysis set title
    Lovenox
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    duration of anticoagulant therapy 6 weeks

    Primary: Occurrence of symptomatic recurrent VTE within 1 year

    		 Close Top of page
    End point title
    		 Occurrence of symptomatic recurrent VTE within 1 year [1]
    End point description
    End point type
    Primary
    End point timeframe
    1 year
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: statistical analyses were performed at John Hopkins All children`s Hospital (St. Petersburg, FL, USA)
    End point values
    		 Marcoumar Marcoumar Lovenox
    Number of subjects analysed
    5
    3
    1
    Units: thrombotic events
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    until follow up visit after 1 year
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No AEs occurred in relation with medication

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jul 2019
    changes to protocol, ICF,screening log, Manual of Operations and recruitment brochure

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun Apr 28 04:12:18 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA