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    Clinical Trial Results:
    Non-invasive parameters in the evaluation of portal hypertension in patients with liver cirrhosis and their significance for the evolution of cardial complications.

    Summary
    EudraCT number
    		 2011-001132-30
    Trial protocol
    		 CZ  
    Global end of trial date
    31 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 May 2021
    First version publication date
    05 May 2021
    Other versions
    Summary report(s)
    		 Article in SJG

    Trial information

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    Trial identification
    Sponsor protocol code
    DIL-2011/04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    General University Hospital in Prague / Všeobecná fakultní nemocnice v Praze
    Sponsor organisation address
    U Nemocnice 2, Prague, Czechia, 12808
    Public contact
    IV. interní klinika, Všeobecná fakultní nemocnice v Praze, 00420 224962580, bruha@cesnet.cz
    Scientific contact
    IV. interní klinika, Všeobecná fakultní nemocnice v Praze, 00420 224962580, bruha@cesnet.cz
    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
    31 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the relationship between the polymorphisms of beta-2 adrenergic receptors to the treatment response in patients with portal hypertension treated with carvedilol
    Protection of trial subjects
    Project was approved by Ethical committee of General University Hospital in Prague.
    Background therapy
    		 It was an observational study on patients treated by carvedilol as a standard of care.
    Evidence for comparator
    		 No comparator.
    Actual start date of recruitment
    01 Sep 2011
    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
    Czechia: 66
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    60
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Observational study - consecutive patients indicated for prophylactic treatment wit betablockers. Only patients in one centre in the Czech Republic.

    Pre-assignment
    Screening details
    		 Observational study - consecutive patients indicated for prophylactic treatment wit betablockers. Pre assigment as a part of routine clinical workup.

    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
    Observational study, no blinding was performed

    Arms
    Arm title
    		 All patients
    Arm description
    		 It was an observational study.
    Arm type
    		 All patients on SOC treatment

    Investigational medicinal product name
    Carvedilol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    12,5 mg twice a day

    Number of subjects in period 1
    		All patients
    Started
    66
    Completed
    66

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 It was an observational study. The study poppulation was patients with standard of care and laboratory parameters were studied

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 66 66
    Age categorical
    Units: Subjects
    Age continuous
    Consecutive patients indicated for the preventive treatment with betablockers (standard of care - observational study).
    Units: years
        arithmetic mean (standard deviation)
    		 57.2 ± 8.9 -
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 44 44
    Subject analysis sets

    Subject analysis set title
    Non-responders
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients not responding to SOC

    Subject analysis set title
    Responders
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients responding to SOC

    Subject analysis sets values
    		 Non-responders Responders
    Number of subjects
    35
    31
    Age categorical
    Units: Subjects
    Age continuous
    Consecutive patients indicated for the preventive treatment with betablockers (standard of care - observational study).
    Units: years
        arithmetic mean (standard deviation)
    54.6 ± 8.4
    59.4 ± 9.9
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 It was an observational study.

    Subject analysis set title
    Non-responders
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients not responding to SOC

    Subject analysis set title
    Responders
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients responding to SOC

    Primary: Response to carvedilol treatment (SOC)

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    End point title
    		 Response to carvedilol treatment (SOC)
    End point description
    End point type
    Primary
    End point timeframe
    The response to the SCO treatment measured as a decrease of HVPG (in mm Hg) after 1 month therapy.
    End point values
    		 Non-responders Responders
    Number of subjects analysed
    35
    31
    Units: mm Hg
        number (not applicable)
    35
    31
    Statistical analysis title
    		 Treatment response
    Statistical analysis description
    the relationship between the allele frequency and treatment response
    Comparison groups
    Responders v Non-responders
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    This was an obseravational stady on patients indicated for the SOC treatment - measurement and collecting the advserse events were performed 1 month after treatment initialisation.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SUKL (CZ)
    Dictionary version
    2011
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 All patients indicated for SOC treatment .

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 66 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 66 (9.09%)
    Cardiac disorders
    Bradycardia
    Additional description: Symptomatic bradycardia
         subjects affected / exposed
    6 / 66 (9.09%)
         occurrences all number
    6

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23452051
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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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