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    Clinical Trial Results:
    Effects of long term albumin 20% administration on the cardiocirculatory and renal function, and hepatic hemodynamics in patients with advanced cirrhosis and ascites.

    Summary
    EudraCT number
    		 2008-003920-40
    Trial protocol
    		 ES  
    Global end of trial date
    02 Apr 2014

    Results information
    Results version number
    		 v1
    This version publication date
    17 Oct 2019
    First version publication date
    17 Oct 2019
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    IG0802
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00968695
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Instituto Grifols, S.A.
    Sponsor organisation address
    Can Guasch 2, Parets del Valles, Barcelona, Spain, 08150
    Public contact
    Mireia Torres, MSc, Instituto Grifols, S.A., mireia.torres@grifols.com
    Scientific contact
    Mireia Torres, MSc, Instituto Grifols, S.A., mireia.torres@grifols.com
    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
    27 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Pharmacodynamics and pathophysiological study to assess the effects of prolonged administration of human albumin on cardiocirculatory and renal function and hepatic hemodynamics in subjects with advanced cirrhosis and ascites.
    Protection of trial subjects
    Standards for Good Clinical Practice were adhered to for all procedures in this clinical study. The investigators ensured that the clinical study was conducted in full conformance with appropriate local laws and regulations and the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Sep 2009
    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: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    20
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Thirty-one subjects of both sexes, aged within 18 to 80 years of age with advance liver cirrhosis and ascites who gave their consent for participation, were included in this study.

    Pre-assignment
    Screening details
    		 Subjects of both sexes, aged 18 to 80 years, with advanced cirrhosis and ascites who gave their written informed consent to participate after being fully informed by the investigator were included in the trial. Subjects met all inclusion criteria and none of the exclusion criteria.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study; therefore no blinding techniques were applicable.

    Arms
    Arm title
    		 ITT Population
    Arm description
    		 The Intention to Treat (ITT) Population was defined as the subset of subjects who received at least one dose of the study medication. The ITT Population was used for all efficacy and safety analyses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Albumin (Human Albumin Grifols 20% solution for infusion)
    Investigational medicinal product code
    B05AA01
    Other name
    Albutein 20%
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pre-interim analysis: The pattern of administration of 20% human albumin was 1g/kg every 2 weeks with a dose minimum of 60g and a maximum of 100g in subjects weighing less than 60kg and more than 100kg, respectively. Post-interim analysis: The pattern of administration of 20% human albumin is 1.5g/kg every week with a minimum of 90g and a maximum of 150g in patients weighing less than 60kg and more than 100kg, respectively. Treatment duration is 12 weeks, which includes 13 administrations of albumin.

    Number of subjects in period 1
    		ITT Population
    Started
    31
    Completed
    13
    Not completed
    18
         Eligibility criteria
    5
         Incorrect number of infusions
    13

    Baseline characteristics

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

    Reporting group values
    		 Overall Study (overall period) Total
    Number of subjects
    		 31 31
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 11 11
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.4 ( 9.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 21 21

    End points

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    End points reporting groups
    Reporting group title
    ITT Population
    Reporting group description
    		 The Intention to Treat (ITT) Population was defined as the subset of subjects who received at least one dose of the study medication. The ITT Population was used for all efficacy and safety analyses.

    Primary: Hemodynamic Parameters

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    End point title
    		 Hemodynamic Parameters [1]
    End point description
    Change in hemodynamic parameters from Baseline to Week 14 are described.
    End point type
    Primary
    End point timeframe
    Baseline to Week 14
    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: As this was not a controlled study and contained only 1 treatment arm, no statistical analyses were required to compare treatment arms.
    End point values
    		 ITT Population
    Number of subjects analysed
    31
    Units: change from baseline
    least squares mean (standard error)
        Systolic blood pressure (mmHg)
    -6.2 ( 3.0 )
        Diastolic blood pressure (mmHg)
    -0.1 ( 2.3 )
        Mean arterial pressure (mmHg)
    0.3 ( 2.2 )
        Right auricular pressure (mmHg)
    -0.2 ( 0.9 )
        Pulmonary arterial pressure (mmHg)
    -1.2 ( 1.4 )
        Pulmonary capillary pressure (mmHg)
    -1.4 ( 1.0 )
        Heart rate (bpm)
    -0.8 ( 2.9 )
        Cardiac output (L/min)
    -1.1 ( 0.4 )
        Cardiac index (L.min-1.m-2)
    -0.6 ( 0.2 )
        Systolic volume (mL)
    -19.2 ( 9.9 )
        Systolic volume index (mL.m-2)
    -14.1 ( 7.5 )
        Systemic vascular resistance (dyn.s.cm-5)
    78.0 ( 61.2 )
        Systemic vascular resistance index(dyn.s.cm-5.m-2)
    180.9 ( 72.4 )
        Left ventricular cardiac work index (g.m/m2)
    267.7 ( 391.7 )
        Free suprahepatic pressure (mmHg)
    2.1 ( 1.2 )
        Suprahepatic pressure locked (mmHg)
    1.5 ( 1.4 )
        Hepatic venous pressure gradient (mmHg)
    -0.6 ( 0.7 )
        Hepatic blood flow (L/min-1)
    -164 ( 238.1 )
    No statistical analyses for this end point

    Primary: Echocardiography Parameters

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    End point title
    		 Echocardiography Parameters [2]
    End point description
    Change in echocardiography parameters from Baseline to Week 14 and Week 20 are described.
    End point type
    Primary
    End point timeframe
    Baseline to Week 14 and Week 20
    Notes
    [2] - 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: As this was not a controlled study and contained only 1 treatment arm, no statistical analyses were required to compare treatment arms.
    End point values
    		 ITT Population
    Number of subjects analysed
    31
    Units: change from baseline
    least squares mean (standard error)
        LV telediastolic diameter (cm) to Week 14
    0.0 ( 0.1 )
        LV telediastolic diameter (cm) to Week 20
    -0.1 ( 0.2 )
        LV telesystolic diameter (cm) to Week 14
    -0.1 ( 0.1 )
        LV telesystolic diameter (cm) to Week 20
    0.0 ( 0.1 )
        Interventricular septum thickness (cm) to Week 14
    0.0 ( 0.0 )
        Interventricular septum thickness (cm) to Week 20
    0.0 ( 0.0 )
        LV posterior wall thickness (cm) to Week 14
    0.0 ( 0.0 )
        LV posterior wall thickness (cm) to Week 20
    0.0 ( 0.0 )
        LV telediastolic volume (mL) to Week 14
    6.1 ( 8.0 )
        LV telediastolic volume (mL) to Week 20
    9.3 ( 10.7 )
        LV telesystolic volume (mL) to Week 14
    -1.8 ( 3.3 )
        LV telesystolic volume (mL) to Week 20
    3.7 ( 4.6 )
        LV ejection fraction (%) to Week 14
    2.9 ( 1.6 )
        LV ejection fraction (%) to Week 20
    1.1 ( 2.0 )
        Wall motion score index to Week 14
    11.9 ( 4.4 )
        Wall motion score index to Week 20
    2.0 ( 5.7 )
        Left ventricular mass (g) to Week 14
    -5.1 ( 13.2 )
        Left ventricular mass (g) to Week 20
    14.2 ( 17.8 )
        Anteroposterior diameter left-atrium (cm) Week 14
    -0.4 ( 0.2 )
        Anteroposterior diameter left-atrium (cm) Week 20
    -0.5 ( 0.3 )
        Early LV filling velocity (cm/s) to Week 14
    -6.8 ( 4.8 )
        Early LV filling velocity (cm/s) to Week 20
    -1.8 ( 6.2 )
        Late LV filling velocity (cm/s) to Week 14
    -3.6 ( 3.8 )
        Late LV filling velocity (cm/s) to Week 20
    2.1 ( 4.8 )
        Early diastolic mitral annular velocity (cm/s) W14
    5.2 ( 4.3 )
        Early diastolic mitral annular velocity (cm/s) W20
    4.6 ( 4.6 )
        Late diastolic mitral annular velocity (cm/s) W14
    0.7 ( 1.0 )
        Late diastolic mitral annular velocity (cm/s) W20
    0.9 ( 1.2 )
        Propagation velocity of flow-LV cavity Week 14
    0.6 ( 8.4 )
        Propagation velocity of flow-LV cavity Week 20
    -11.9 ( 8.7 )
        Systolic pulmonary venous flow velocity (cm/s) W14
    1.0 ( 4.8 )
        Systolic pulmonary venous flow velocity (cm/s) W20
    10.3 ( 6.5 )
        Diastolic pulmonary venous flow velocity(cm/s) W14
    7.2 ( 5.4 )
        Diastolic pulmonary venous flow velocity(cm/s) W20
    9.5 ( 6.6 )
    No statistical analyses for this end point

    Primary: Hormonal Parameters

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    End point title
    		 Hormonal Parameters [3]
    End point description
    Change in hormonal parameters from Baseline to Week 14 and to Week 20 are described.
    End point type
    Primary
    End point timeframe
    Baseline to Week 14 and Week 20
    Notes
    [3] - 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: As this was not a controlled study and contained only 1 treatment arm, no statistical analyses were required to compare treatment arms.
    End point values
    		 ITT Population
    Number of subjects analysed
    31
    Units: change from baseline
    least squares mean (standard error)
        Plasma rennin activity (ng/mL/h) to Week 14
    -1.3 ( 2.0 )
        Plasma rennin activity (ng/mL/h) to Week 20
    -1.6 ( 2.1 )
        Noradrenaline (pg/mL) to Week 14
    21.7 ( 113.9 )
        Noradrenaline (pg/mL) to Week 20
    71.9 ( 116.1 )
    No statistical analyses for this end point

    Primary: Isotopic Parameters

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    End point title
    		 Isotopic Parameters [4]
    End point description
    Change in isotopic parameters from Baseline to Week 14 are described.
    End point type
    Primary
    End point timeframe
    Baseline to Week 14
    Notes
    [4] - 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: As this was not a controlled study and contained only 1 treatment arm, no statistical analyses were required to compare treatment arms.
    End point values
    		 ITT Population
    Number of subjects analysed
    31
    Units: change from baseline
    least squares mean (standard error)
        Renal blood flow (mL/min/m2)
    11.2 ( 41.2 )
        Glomerular filtration rate (mL/min/m2)
    -2.1 ( 3.5 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Subjects were monitored from the time of the signature of the ICF to the end of the follow-up period (Week 20) for assessment of AEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    ITT Population
    Reporting group description
    		 The Intention to Treat (ITT) Population was defined as the subset of subjects who received at least one dose of the study medication. The ITT Population was used for all efficacy and safety analyses.

    Serious adverse events
    		 ITT Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 31 (54.84%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    5
    Injury, poisoning and procedural complications
    Osteoporotic fracture
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial tachycardia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spur cell anaemia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound secretion
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    6 / 31 (19.35%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 1
    Incarcerated umbilical hernia
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal incarcerated hernia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric disorder
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mesenteric vein thrombosis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic encephalopathy
         subjects affected / exposed
    9 / 31 (29.03%)
         occurrences causally related to treatment / all
    0 / 12
         deaths causally related to treatment / all
    0 / 2
    Ascites
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Acute on chronic liver failure
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hepatic failure
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Portal hypertensive gastropathy
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pleural effusion
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
    Additional description: renal failure renal impairment
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    Acute kidney injury
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Renal impairment
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Bacteraemia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Peritonitis bacterial
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Sepsis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 ITT Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 31 (54.84%)
    Vascular disorders
    Ecchymosis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    General disorders and administration site conditions
    Drug intolerance
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Infusion site extravasation
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Metrorrhagia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    2
    Respiratory tract infection
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Limb injury
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Presyncope
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Vertigo
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences all number
    9
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Haematemesis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Oesophageal haemorrhage
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic encephalopathy
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    3
    Ascites
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Minimal hepatic encephalopathy
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    Prurigo
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Humerus fracture
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Sciatica
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Infections and infestations
    Cellulitis staphylococcal
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2009
    To allow the inclusion of subjects who were being treated with beta-blocking drugs. The reason was that most subjects in the study population were being treated with these drugs. Therefore, allowing the inclusion of these subjects increases the number of subjects available for the study and it was possible that the sample was more similar to the study population, which was taken into account for the eventual design of Phase III. Plan to carry out an intermediate analysis when half of the expected sample (15 subjects) was recruited. If the efficacy results were positive for the product under study, it would follow the established plan. On the other hand, if the efficacy results were not positive and no serious safety problems were detected, the dose of albumin would be increased to 1.5g/kg every 2 weeks (with a minimum of 90g and a maximum of 150g per administration).
    16 Mar 2010
    The amount of blood drawn for each determination was increased from 5 ml to 10 ml. The reason was that it was observed in subjects already included in the clinical trial that a volume of 5 ml was insufficient to accurately determine the hormonal parameters. The extraction route was modified with Medicut® of 18 or 20 F, the 22F pathways are excessively small and do not allow the extraction of blood by vacuum which could contribute to the sample hemolysis. The paragraph of "prohibited treatments" and Annex 6 "Data Collection Notebook" was modified.
    27 Sep 2011
    In the intermediate analysis carried out by the investigators on the variable "plasma renin activity" the expected decrease was not observed but a slight increase (although not statistically significant): 7.1ng/mL.h at the start compared to 11.5 ng/mL.h in week 14. Given that the original design of the study did not take into account that the pharmacokinetic parameters of albumin are altered in patients with cirrhosis due to the increase in the volume of distribution, it is proposed to increase the expected maximum frequency of administration of albumin from 1.5 g/kg every 2 weeks to 1.5 g/kg every week (with a minimum of 90g and a maximum of 150g per administration).
    14 Jun 2012
    Specify that the 30 subjects scheduled for inclusion should complete all infusions of albumin according to protocol.

    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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