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    Clinical Trial Results:
    Description of the evolution of plasma and urinary concentrations of iohexol in a cirrhotic patient population. "Pilot study on 9 patients"

    Summary
    EudraCT number
    		 2018-002778-35
    Trial protocol
    		 FR  
    Global end of trial date
    28 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jul 2021
    First version publication date
    04 Jul 2021
    Other versions
    Summary report(s)
    		 Statistical and safety analysis report
    Summuray of Final report

    Trial information

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    Trial identification
    Sponsor protocol code
    87RI18_0008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03769597
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Limoges University Hospital
    Sponsor organisation address
    2 Av Martin Luther King, Limoges, France, 87042
    Public contact
    Direction Research and Innovation, CHU de LIMOGES, +33 555058911, drc@chu-limoges.fr
    Scientific contact
    Direction Research and Innovation, Limoges University Hospital, +33 555058911, drc@chu-limoges.fr
    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
    11 Jun 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Describe the evolution of plasma and urinary concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics.
    Protection of trial subjects
    The trial was carried out in accordance with the regulation, the ICH and the Helsinki declaration. All patients have been informed and have given their consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Feb 2019
    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
    France: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    8
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Thirteen patients were included (out of 9 required) between 02/11/2019 and 08/17/2019 because four were replaced (one secondary exclusion and three withdrawals of consent). These patients were followed according to protocol.

    Pre-assignment
    Screening details
    		 Patients with advanced hepatic disease are recruited for consultation or hospitalization in the hepato-gastroenterology department by hepatologists. Recruitment takes place in the CHUs of Limoges over a period of 12 months.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Iohexol administration
    Arm description
    		 After injecting a loading dose of 5ml of Iohexol Inj 300 MG/ML bolus, blood samples will be taken at given times for 24 hours. The urinary samples will be taken at each urination, with measurement of the exact volume and times
    Arm type
    		 Experimental

    Investigational medicinal product name
    OMNIPAQUE
    Investigational medicinal product code
    SUB08228MIG
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Solution for injection , Intravenous use
    Dosage and administration details
    After injecting a loading dose of 5ml of Iohexol Inj 300 MG/ML bolus, blood samples will be taken at given times for 24 hours. The urinary samples will be taken at each urination, with measurement of the exact volume and times.

    Number of subjects in period 1
    		Iohexol administration
    Started
    13
    Completed
    10
    Not completed
    3
         Consent withdrawn by subject
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 5 5
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 13 13
    Subject analysis sets

    Subject analysis set title
    all patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A total of 9 patients were consecutively included in our study, exclusively men. It should be noted that during the inclusion period, 3 other patients were screened, signed their informed consent at the V0 visit, but secondarily withdrew their consent.

    Subject analysis sets values
    		 all patients
    Number of subjects
    10
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    6
        From 65-84 years
    4
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    10

    End points

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    End points reporting groups
    Reporting group title
    Iohexol administration
    Reporting group description
    		 After injecting a loading dose of 5ml of Iohexol Inj 300 MG/ML bolus, blood samples will be taken at given times for 24 hours. The urinary samples will be taken at each urination, with measurement of the exact volume and times

    Subject analysis set title
    all patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A total of 9 patients were consecutively included in our study, exclusively men. It should be noted that during the inclusion period, 3 other patients were screened, signed their informed consent at the V0 visit, but secondarily withdrew their consent.

    Primary: Description of the pharmacological curves of plasma and urinary concentrations of iohexol as a function of time

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    End point title
    		 Description of the pharmacological curves of plasma and urinary concentrations of iohexol as a function of time
    End point description
    End point type
    Primary
    End point timeframe
    0 minute, 15 minute, 30 minute, 1 hour, 90 minute, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
    End point values
    		 Iohexol administration all patients
    Number of subjects analysed
    10
    10
    Units: mg d'I/mL
        number (not applicable)
    0
    0
    Statistical analysis title
    		 Primary End point
    Comparison groups
    Iohexol administration v all patients
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1 [1]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [1] - no p-value defined

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    overall study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    all patients
    Reporting group description
    		 -

    Serious adverse events
    		 all patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Haemorrhagic ulcer
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute prostatitis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 all patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    General disorders and administration site conditions
    Extravasation blood
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1

    More information

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    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
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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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