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    Clinical Trial Results:
    Association between variations in CYP pheno- and genotypes and plasma concentration of chlordiazepoxide in the treatment of alcohol withdrawal symptoms

    Summary
    EudraCT number
    		 2021-002188-23
    Trial protocol
    		 DK  
    Global end of trial date
    11 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2024
    First version publication date
    26 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KLOPOXID2021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg and Frederiksberg Hospital
    Sponsor organisation address
    Bispebjerg Bakke 23, opgang 20c st. th., København NV, Denmark, 2400
    Public contact
    Christian Sylvest Meyhoff, Bispebjerg and Frederiksberg Hospital, +45 24910542, christian.sylvest.meyhoff@regionh.dk
    Scientific contact
    Christian Sylvest Meyhoff, Bispebjerg and Frederiksberg Hospital, +45 24910542, christian.sylvest.meyhoff@regionh.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
    21 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to elucidate if CYP phenotypes, variations in CYP genotypes and dose of chlordiazepoxide are correlated to the concentration of chlordiazepoxide in patients admitted to ICU or Intermediate Care Department (ICD) for respiratory insufficiency and/or agitation in relation to alcohol withdrawal symptoms.
    Protection of trial subjects
    No specific measure were taken to protect trial subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2021
    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
    Denmark: 27
    Worldwide total number of subjects
    27
    EEA total number of subjects
    27
    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)
    18
    From 65 to 84 years
    8
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients aged more than 18 years who had been treated with at least 200 mg of chlordizapoxide for alcohol withdrawal symptoms and were admitted to either ICU or HDU due to somnolence respiratory insufficiency or agitation were elligible for inclusion. Patients were included no later than 12 hours after ICU or HDU admittance.

    Pre-assignment
    Screening details
    		 Patients aged more than 18 years who had been treated with at least 200 mg of chlordizapoxide for alcohol withdrawal symptoms and were admitted to either ICU or HDU due to somnolence respiratory insufficiency or agitation were screened for inclusion.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Patients were not blinded.

    Arms
    Arm title
    		 Included
    Arm description
    		 treatment with chlordizapoxide preceeded inclusion. No intervention was performed during the study period.
    Arm type
    		 No Intervention

    Investigational medicinal product name
    No Product
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Chlordizepoxide was administered before inclusion in the study.

    Number of subjects in period 1
    		Included
    Started
    27
    Completed
    26
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 27 27
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 18 18
        From 65-84 years
    		 8 8
        85 years and over
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61 ( 12 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 21 21
        Not Recorded
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Included
    Reporting group description
    		 treatment with chlordizapoxide preceeded inclusion. No intervention was performed during the study period.

    Primary: plasma concentration of chlordiazepoxide

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    End point title
    		 plasma concentration of chlordiazepoxide [1]
    End point description
    End point type
    Primary
    End point timeframe
    At inclusion and 12 h after inclusion.
    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: In this study there were no comparisons between arms. All patients were included after having recieved Chlordizepoxide. The study population was divided into two groups according to phenotypes. Phenotypes were analyzed after inclusion. Results are presented in tables under "Charts".
    End point values
    		 Included
    Number of subjects analysed
    26
    Units: µg/mL
    number (not applicable)
        CYP3A4 Normal/ CYP2C19 Slow
    8
        CYP3A4 Normal/ CYP2C19 Normal
    9
        CYP3A4 Normal/ CYP2C19 Fast
    7
        CYP3A4 Fast/ CYP2C19 Fast
    2
    Attachments
    		 Pheno- and genotypes associated to plasma conc.
    Table 2. Association between CYP phenotypes and p-
    Table 3. Association between treatment with invasi
    No statistical analyses for this end point

    Secondary: Cumulative dose of chlordiazepoxide before admission to ICU/ICD

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    End point title
    		 Cumulative dose of chlordiazepoxide before admission to ICU/ICD
    End point description
    End point type
    Secondary
    End point timeframe
    February 2023-june 2023
    End point values
    		 Included
    Number of subjects analysed
    26 [2]
    Units: mg
        Cumulative dose of chlordizapoxide before ICU/HDU
    825
    Notes
    [2] - 825 [200 - 2100] median [5-95 Percentile]
    No statistical analyses for this end point

    Secondary: ICU length of stay (LOS)

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    End point title
    		 ICU length of stay (LOS)
    End point description
    End point type
    Secondary
    End point timeframe
    February 2023-june 2023
    End point values
    		 Included
    Number of subjects analysed
    26 [3]
    Units: Days
        Median LOS in ICU
    7
        Median LOS in ICU/HDU
    3
    Notes
    [3] - ICU: 6.5 [1.8 - 17] ICU/HDU: 3.2 [1.5 - 18.4] median [5 - 95 percentile]
    No statistical analyses for this end point

    Secondary: Need for Invasive mechanical ventilation

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    End point title
    		 Need for Invasive mechanical ventilation
    End point description
    End point type
    Secondary
    End point timeframe
    February 2023-june 2023
    End point values
    		 Included
    Number of subjects analysed
    26
    Units: yes/no
        yes
    8
        No
    18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From inclusion until 12 h after inclusion
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Meriam-Webster
    Dictionary version
    2024
    Reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 26 patients were included in the overall study.

    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: Non serious adverse events were not recorded. Chlordiazepoxide was administered before inclusion in the study and was not administered during the 12 h study period.
    Serious adverse events
    		 Overall study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 26 (7.69%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Vasopressive therapy
    Additional description: One patient was sedated in association with mechanical ventilation and needed norepinephrine due to hypotension induced by sedation. Need for vasopressive therapy is unlikely associated to blood sampling or the study pharmacological probes.
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Mechanical ventilation
    Additional description: Mechanical ventilation was used in treatment of severe pneumonia and lung embolus during the 12 h study period. Both conditions are often treated with mechanical ventilation, and therefore expected, and unlikely associated to the study.
         subjects affected / exposed
    2 / 26 (7.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)

    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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