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    Clinical Trial Results:
    Albumin infusion effects in patients with cirrhosis hepatic encephalopathy

    Summary
    EudraCT number
    		 2014-004809-33
    Trial protocol
    		 ES  
    Global end of trial date
    08 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2021
    First version publication date
    06 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BETA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02401490
    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, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Inmaculada Fuentes, VHIR-Unitat de Suport a la Investigació Clínica (USIC), usic@vhir.org
    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
    Interim
    Date of interim/final analysis
    08 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether albumin administration after an episode of hepatic encephalopathy improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation).
    Protection of trial subjects
    The underlying HE cause was properly addressed according to guidelines. Moreover, laxative treatment was administered
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Mar 2015
    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: 82
    Worldwide total number of subjects
    82
    EEA total number of subjects
    82
    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)
    40
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 82
    Number of subjects completed
    		 82

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Albumin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Albumin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    The first dose was administered within the first 48 hours of admission with an HE grade ≥2 (1.5g/kg of albumin or the equivalent milliliter of saline solution). The second dose (1g/kg of albumin or the equivalent milliliters of saline solution) was administered 48 to 72 hours after the first administration. Both doses where adjusted according to ideal weight and infused at 5ml/hour.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    The first dose was administered within the first 48 hours of admission with an HE grade ≥2 ( the equivalent milliliter of saline solution to 1.5g/kg of albumin). The second dose (the equivalent milliliters of saline solution to 1g/kg of albumin) was administered 48 to 72 hours after the first administration. Both doses where adjusted according to ideal weight and infused at 5ml/hour.

    Number of subjects in period 1
    		Albumin Placebo
    Started
    41
    41
    Completed
    41
    40
    Not completed
    0
    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
    		 82 82
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 40 40
        From 65-84 years
    		 42 42
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 27 27
        Male
    		 55 55

    End points

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    End points reporting groups
    Reporting group title
    Albumin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Survival at 180 days

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    End point title
    		 Survival at 180 days
    End point description
    End point type
    Primary
    End point timeframe
    180 days
    End point values
    		 Albumin Placebo
    Number of subjects analysed
    40
    40
    Units: percent
        number (not applicable)
    78.7
    67.8
    Statistical analysis title
    		 Survival 180 days
    Comparison groups
    Placebo v Albumin
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.2413
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Survival at 90 days

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    End point title
    		 Survival at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Albumin Placebo
    Number of subjects analysed
    41
    40
    Units: percent
        number (not applicable)
    87.36
    80.49
    Statistical analysis title
    		 Survival 90 days
    Comparison groups
    Albumin v Placebo
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.38
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    End of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Albumin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Albumin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 40 (22.50%)
    26 / 40 (65.00%)
         number of deaths (all causes)
    14
    19
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 40 (7.50%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic encephalopathy
         subjects affected / exposed
    9 / 40 (22.50%)
    11 / 40 (27.50%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal syndrome
         subjects affected / exposed
    4 / 40 (10.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 40 (7.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Peritonitis bacterial
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 40 (0.00%)
    3 / 40 (7.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Albumin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 40 (85.00%)
    11 / 40 (27.50%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 40 (10.00%)
    5 / 40 (12.50%)
         occurrences all number
    4
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 40 (10.00%)
    1 / 40 (2.50%)
         occurrences all number
    4
    1
    Hepatobiliary disorders
    Hepatic encephalopathy
         subjects affected / exposed
    9 / 40 (22.50%)
    9 / 40 (22.50%)
         occurrences all number
    12
    12
    Ascites
         subjects affected / exposed
    13 / 40 (32.50%)
    4 / 40 (10.00%)
         occurrences all number
    13
    4
    Hepatocellular carcinoma
         subjects affected / exposed
    4 / 40 (10.00%)
    2 / 40 (5.00%)
         occurrences all number
    4
    2
    Hepatorenal syndrome
         subjects affected / exposed
    3 / 40 (7.50%)
    2 / 40 (5.00%)
         occurrences all number
    3
    2
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    6 / 40 (15.00%)
    2 / 40 (5.00%)
         occurrences all number
    6
    2
    Acute kidney injury
         subjects affected / exposed
    1 / 40 (2.50%)
    5 / 40 (12.50%)
         occurrences all number
    1
    5
    Urinary tract infection
         subjects affected / exposed
    3 / 40 (7.50%)
    3 / 40 (7.50%)
         occurrences all number
    3
    3
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    4 / 40 (10.00%)
    2 / 40 (5.00%)
         occurrences all number
    4
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2015
    Changes in the MELD score range from 15-25 to 14-30 was approved in order to increase recruitment.

    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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