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   43872   clinical trials with a EudraCT protocol, of which   7291   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:
    Determination of radiation dose for the bile acid tracer 11C-CSar in humans

    Summary
    EudraCT number
    		 2016-004031-20
    Trial protocol
    		 DK  
    Global end of trial date
    26 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Dec 2020
    First version publication date
    26 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    0090
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    senior lecturer, Aarhus University Hospital, 45 30939936, susakeid@clin.au.dk
    Scientific contact
    senior lecturer, Aarhus University Hospital, 45 30939936, susakeid@clin.au.dk
    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
    26 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Mar 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the trial is to define biodistribution of 11C-CSar in the human body in healthy subjects and patients with cholestatic liver disease and to estimate equivalent dose exposure.
    Protection of trial subjects
    This study conformed to the standards of conduct for clinical studies as set forth in the Declaration of Helsinki and the legal regulations in Denmark. International Conference on Harmonization (ICH) guidelines for good clinical practices (GCP) was followed. After written approval from the Independent Ethics Committee (IEC) and competent authority has been obtained, the Investigator obtained informed consent from the subject’s legally acceptable representative.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Dec 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 6 healthy subjects included were screened for no liver disease. 3 patients were included from out-patients clinic, two with primary biliary cholangitis and one with primary sclerosing cholangitis - under standard medical treatment.

    Pre-assignment period milestones
    Number of subjects started
    		 9
    Number of subjects completed
    		 8

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PET-scanning with bile acid tracer
    Arm description
    		 Subjects were examined by wholebody PET-scan with 11C-CSar bile acid tracer and a blood-sample to dertermine bile acid concentration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    11C-cholylsarcosine
    Investigational medicinal product code
    V09DX
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    60-143 MBq megabecquerel(s) Intravenous bolus use

    Number of subjects in period 1 [1]
    		PET-scanning with bile acid tracer
    Started
    8
    Completed
    8
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: There was one withdrawn participant.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 60 (34 to 73) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 4 4

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    PET-scanning with bile acid tracer
    Reporting group description
    		 Subjects were examined by wholebody PET-scan with 11C-CSar bile acid tracer and a blood-sample to dertermine bile acid concentration.

    Primary: Gender-averaged effective dose (healthy)

    		 Close Top of page
    End point title
    		 Gender-averaged effective dose (healthy) [1]
    End point description
    End point type
    Primary
    End point timeframe
    The endpoint analyzed within three days of the examination. Measurable unit were: microSv/MBq
    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: For statistical analysis, see linked publication
    End point values
    		 PET-scanning with bile acid tracer
    Number of subjects analysed
    6
    Units: sievert
        arithmetic mean (standard deviation)
    6.2 ( 1.4 )
    No statistical analyses for this end point

    Primary: Gender-averaged effective dose (healthy)

    		 Close Top of page
    End point title
    		 Gender-averaged effective dose (healthy) [2]
    End point description
    End point type
    Primary
    End point timeframe
    The endpoint analyzed within three days of the examination. Measurable unit were: microSv/MBq
    Notes
    [2] - 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: For statistical analysis, see linked publication
    End point values
    		 PET-scanning with bile acid tracer
    Number of subjects analysed
    2
    Units: sievert
        arithmetic mean (standard deviation)
    6.1 ( 1.2 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse Events were collected during the whole study. No adverse events were reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13
    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 adverse events (non-serious or serious) were reported.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31330413
    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-Mon May 06 14:27:36 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA