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    Clinical Trial Results:
    Effects of rifaximin administration in patients with severe acute alcoholic hepatitis. Comparative pilot study.

    Summary
    EudraCT number
    2012-000515-80
    Trial protocol
    ES  
    Global end of trial date
    03 Nov 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Dec 2021
    First version publication date
    19 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RIFA-AAH
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02116556
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano , VHIR, +34 934894779, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Sponsor and coordinator, Juan Córdoba, +34 932746140, jcordoba@vhebron.net
    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
    03 Nov 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether the administration of rifaximin as an adjunct to corticosteroids decreases the number of bacterial infections in patients 90 days with acute alcoholic hepatitis.
    Protection of trial subjects
    At all time points and during follow-up visits, physical examination, laboratory measurements, presence of bacterial infections, and any liver-related complications were surveyed, including presence or worsening of ascites, gastrointestinal bleeding (GIB), and acute-on-chronic liver failure (ACLF)
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Jun 2012
    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
    Spain: 63
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    55
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study included 21 consecutive patients recruited from June 2013 to June 2015 who were admitted to four tertiary hospitals in Barcelona. Treated patients were compared with a carefully matched historical cohort of patients treated with standard therapy and paired by age and model for end-stage liver disease (MELD).

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    63
    Number of subjects completed
    63

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Prednisone
    Arm description
    Prednisone plus standard supportive care measurements
    Arm type
    Active comparator

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone PO 40mg/day for 30 days plus standard supportive care measurements

    Arm title
    Rifamixin
    Arm description
    Rifaximin PO 1200 mg/day for 90 days added to standard treatment
    Arm type
    Experimental

    Investigational medicinal product name
    Rifamixin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rifaximin PO 1200 mg/day for 90 days

    Number of subjects in period 1
    Prednisone Rifamixin
    Started
    42
    21
    Completed
    42
    21

    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
    63 63
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (inter-quartile range (Q1-Q3))
    54.5 (45 to 61) -
    Gender categorical
    Units: Subjects
        Female
    19 19
        Male
    44 44

    End points

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    End points reporting groups
    Reporting group title
    Prednisone
    Reporting group description
    Prednisone plus standard supportive care measurements

    Reporting group title
    Rifamixin
    Reporting group description
    Rifaximin PO 1200 mg/day for 90 days added to standard treatment

    Primary: Bacterial infections at 90 days

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    End point title
    Bacterial infections at 90 days
    End point description
    End point type
    Primary
    End point timeframe
    90 days
    End point values
    Prednisone Rifamixin
    Number of subjects analysed
    42
    21
    Units: Number
        number (not applicable)
    26
    6
    Statistical analysis title
    Infections at 90 days
    Comparison groups
    Prednisone v Rifamixin
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    > 0.05
    Method
    Chi-squared
    Confidence interval

    Secondary: De novo ACLF

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    End point title
    De novo ACLF
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    Prednisone Rifamixin
    Number of subjects analysed
    42
    21
    Units: Patients
        number (not applicable)
    9
    1
    Statistical analysis title
    ACLF de novo
    Comparison groups
    Prednisone v Rifamixin
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.81
    Method
    Chi-squared
    Confidence interval

    Secondary: Liver-related complication

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    End point title
    Liver-related complication
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    Prednisone Rifamixin
    Number of subjects analysed
    42
    21
    Units: Complications/patient
        number (not applicable)
    1.26
    0.43
    Statistical analysis title
    Liver complications/patient
    Comparison groups
    Prednisone v Rifamixin
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.01
    Method
    t-test, 1-sided
    Confidence interval

    Secondary: Infection-free survival time

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    End point title
    Infection-free survival time
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    Prednisone Rifamixin
    Number of subjects analysed
    42
    21
    Units: day
        number (not applicable)
    57.1
    70.6
    Statistical analysis title
    Infection-free survival time
    Comparison groups
    Prednisone v Rifamixin
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.12
    Method
    t-test, 2-sided
    Confidence interval

    Secondary: Total complications

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    End point title
    Total complications
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    Prednisone Rifamixin
    Number of subjects analysed
    42
    21
    Units: Number/patient
        number (not applicable)
    1.26
    0.43
    Statistical analysis title
    Total complications
    Comparison groups
    Prednisone v Rifamixin
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.01
    Method
    t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    90 days
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Rifamixin treated
    Reporting group description
    -

    Serious adverse events
    Rifamixin treated
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 21 (52.38%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cerebral vasculitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Right upper extremity paresis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Social circumstances
    Suicidal behaviour
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Rectal ulcer
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchoaspiration
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Pancreatitis acute
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Rifamixin treated
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 21 (57.14%)
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Mesogastrium pain
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Epidermoid cyst excision
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Hand burn
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 21 (4.76%)
         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.
    This was a pilot study, so it was underpowered by the sample size. Further studies with bigger populations should confirm these results.
    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.

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