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    Clinical Trial Results:
    The effects of purified n-3 fatty acids on serum biomarkers and cardiovascular risk markers in a randomized placebo controlled trial in patients with non alcoholic fatty liver disease

    Summary
    EudraCT number
    		 2008-003766-26
    Trial protocol
    		 GB  
    Global end of trial date
    29 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jan 2019
    First version publication date
    24 Jan 2019
    Other versions
    Summary report(s)
    		 Effects of Purified Eicosapentaenoic and Docosahexaenoic Acids in the Nonalcoholic Fatty Liver Disease: Results form the WELCOME Study
    Design and rationale of the WELCOME trial: A randomised placebo controlled study to test the efficacy of purified long chain omega-3 fatty treatment in non-alcoholic fatty liver disease

    Trial information

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    Trial identification
    Sponsor protocol code
    25-12-59
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00760513
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Southampton NHS Foundation Trust
    Sponsor organisation address
    Tremona Road, Southampton, United Kingdom,
    Public contact
    Dr Mikayala King, University Hospital Southampton NHS Foundation Trust, mikayala.king@uhs.nhs.uk
    Scientific contact
    Lucinda England, University of Southampton , l.c.england@soton.ac.uk
    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
    29 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of our study is to phenotype 100 people with NAFLD, either biopsy-proven or confirmed by non-invasive imaging in a high-risk cohort (i.e. diabetic and/or features of the metabolic syndrome), and randomize subjects to treatment with purified n-3 fatty acids (OMACOR) 4 g / day or to placebo for 15-18 months. The primary end-points of the study are: a) to assess change in serum biomarkers with treatment b) to measure changes in liver fat and validate changes in biomarkers with changes in liver fat
    Protection of trial subjects
    Liver biopsy is not without hazard, with the main complication being bleeding which requires intervention in around 1:1000 cases. The study has therefore opted to recruit volunteers with biopsy-proven NAFLD who have already undergone liver biopsy for diagnostic purposes or fatty liver diagnosed through non-invasive imaging e.g. liver ultrasound/CT/MRI who also have either diabetes or features of metabolic syndrome.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jan 2010
    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
    United Kingdom: 103
    Worldwide total number of subjects
    103
    EEA total number of subjects
    103
    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)
    93
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First Patient Recruited took place on 12/01/2010, Last Patient Recruited was on 08/09/2011.Recruitment took place at University Hospital Southampton NHS FT as a single site. Other local collaborators responsible for the care of patients with NAFLD provided potential patients with patient information sheets however consent took place at UHS.

    Pre-assignment
    Screening details
    		 The study team identified a cohort of patients with non-alcoholic fatty liver disease diagnosed on either radiological or biopsy criteria for NAFLD with exclusion of other causes of chronic liver disease.

    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
    Blinding implementation details
    Volunteers were randomised via a computerised randomisation by a research Pharmacist at University Hospital NHS Foundation Trust

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active Comparator - OMACOR
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    OMACOR
    Investigational medicinal product code
    Other name
    Lovaza
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 grams per day for minimum 15 months and maximum 18 months

    Arm title
    		 Placebo comparator - Dummy pill
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 grams daily orally

    Number of subjects in period 1
    		Active Comparator - OMACOR Placebo comparator - Dummy pill
    Started
    51
    52
    Completed
    47
    48
    Not completed
    4
    4
         Consent withdrawn by subject
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active Comparator - OMACOR
    Reporting group description
    		 -

    Reporting group title
    Placebo comparator - Dummy pill
    Reporting group description
    		 -

    Reporting group values
    		 Active Comparator - OMACOR Placebo comparator - Dummy pill Total
    Number of subjects
    		 51 52 103
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 47 46 93
        From 65-84 years
    		 4 6 10
    Age continuous
    Units: years
        log mean (standard deviation)
    		 48.6 ( 11.1 ) 54 ( 9.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 26 17 43
        Male
    		 25 35 60
    Region of Enrollment
    Units: Subjects
        United Kingdom
    		 51 52 103

    End points

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    End points reporting groups
    Reporting group title
    Active Comparator - OMACOR
    Reporting group description
    		 -

    Reporting group title
    Placebo comparator - Dummy pill
    Reporting group description
    		 -

    Primary: Change of Liver Fat Percentage

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    End point title
    		 Change of Liver Fat Percentage
    End point description
    End point type
    Primary
    End point timeframe
    18 months
    End point values
    		 Active Comparator - OMACOR Placebo comparator - Dummy pill
    Number of subjects analysed
    46
    45
    Units: Percentage of Liver Fat
        log mean (standard deviation)
    -7.9 ( 17.4 )
    -4.6 ( 9.2 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Active Comparator - OMACOR v Placebo comparator - Dummy pill
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -3.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8
         upper limit
    		 0.8
    Variability estimate
    Standard deviation

    Primary: Change in Liver Fibrosis Score

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    End point title
    		 Change in Liver Fibrosis Score
    End point description
    End point type
    Primary
    End point timeframe
    18 months
    End point values
    		 Active Comparator - OMACOR Placebo comparator - Dummy pill
    Number of subjects analysed
    46
    45
    Units: Unit on Scale
        log mean (standard deviation)
    0.3 ( 0.6 )
    0.2 ( 0.6 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo comparator - Dummy pill v Active Comparator - OMACOR
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 0.33
    Variability estimate
    Standard deviation

    Primary: Change in NAFLD Fibrosis Score

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    End point title
    		 Change in NAFLD Fibrosis Score
    End point description
    End point type
    Primary
    End point timeframe
    18 months
    End point values
    		 Active Comparator - OMACOR Placebo comparator - Dummy pill
    Number of subjects analysed
    46
    45
    Units: Unit on Scale
        log mean (standard deviation)
    0.8 ( 0.9 )
    0.8 ( 0.7 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Active Comparator - OMACOR v Placebo comparator - Dummy pill
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.3
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    18 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Omega 3 Fatty Acid (OMACOR) Active Arm
    Reporting group description
    		 -

    Reporting group title
    Dummy Pill Placebo Arm
    Reporting group description
    		 -

    Serious adverse events
    		 Omega 3 Fatty Acid (OMACOR) Active Arm Dummy Pill Placebo Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 51 (7.84%)
    8 / 52 (15.38%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Chest Pain radiating to the neck with tingling to left arm
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Laparoscopy and appendectomy
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillectomy
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Elective Hysterectomy
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laparoscopic adhesiolysis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Removal of myxoma
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seminoma
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anaemia and disorientation
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Asthma Attack
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Severe Chest Pain
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Cellulitis on Right Lateral Melleolus
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Stabilisation of Diabetes
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Omega 3 Fatty Acid (OMACOR) Active Arm Dummy Pill Placebo Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 51 (96.08%)
    44 / 52 (84.62%)
    General disorders and administration site conditions
    Accidental Fall
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    2
    Achille's Heel and foot problems
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    2
    Anxiety and Depression
         subjects affected / exposed
    4 / 51 (7.84%)
    2 / 52 (3.85%)
         occurrences all number
    4
    2
    Dental Disorders
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    2
    Fall and fracture
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Fluid retention and oedema
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    2
    Headache and dizziness
         subjects affected / exposed
    6 / 51 (11.76%)
    6 / 52 (11.54%)
         occurrences all number
    6
    6
    Hypertension
         subjects affected / exposed
    5 / 51 (9.80%)
    1 / 52 (1.92%)
         occurrences all number
    5
    1
    Insomnia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Fertility problems
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Gynaecological Disorders
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 52 (1.92%)
         occurrences all number
    2
    1
    Pregnancy
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma and breathing
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 52 (0.00%)
         occurrences all number
    3
    0
    Flu, cough and sore throat
         subjects affected / exposed
    13 / 51 (25.49%)
    5 / 52 (9.62%)
         occurrences all number
    13
    5
    Product issues
    Other drug overdose
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Other drug reaction
         subjects affected / exposed
    5 / 51 (9.80%)
    0 / 52 (0.00%)
         occurrences all number
    5
    0
    Cardiac disorders
    Chest Pain and ECG alterations
         subjects affected / exposed
    5 / 51 (9.80%)
    5 / 52 (9.62%)
         occurrences all number
    5
    5
    Nervous system disorders
    Neurological Disorders
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Otolaryngological Disorders
         subjects affected / exposed
    10 / 51 (19.61%)
    3 / 52 (5.77%)
         occurrences all number
    10
    3
    Eye disorders
    Ophtalmological Disorders
         subjects affected / exposed
    0 / 51 (0.00%)
    6 / 52 (11.54%)
         occurrences all number
    0
    6
    Gastrointestinal disorders
    Nausea and Vomiting
         subjects affected / exposed
    3 / 51 (5.88%)
    4 / 52 (7.69%)
         occurrences all number
    3
    4
    Diarrhoea
         subjects affected / exposed
    4 / 51 (7.84%)
    6 / 52 (11.54%)
         occurrences all number
    4
    6
    Gastrointestinal disorder
         subjects affected / exposed
    6 / 51 (11.76%)
    5 / 52 (9.62%)
         occurrences all number
    6
    5
    Proctological Disorders
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 52 (5.77%)
         occurrences all number
    3
    3
    Hepatobiliary disorders
    Hepatological Disorder
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Liver Biopsy
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatological Disorders
         subjects affected / exposed
    8 / 51 (15.69%)
    9 / 52 (17.31%)
         occurrences all number
    8
    9
    Renal and urinary disorders
    Urological Disorders
         subjects affected / exposed
    5 / 51 (9.80%)
    11 / 52 (21.15%)
         occurrences all number
    5
    11
    Endocrine disorders
    Onset Diabetes
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 52 (1.92%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Back Pain and Sciatica
         subjects affected / exposed
    3 / 51 (5.88%)
    2 / 52 (3.85%)
         occurrences all number
    3
    2
    Carpal Disorders
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Fibromyalgia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    Joint pain
         subjects affected / exposed
    13 / 51 (25.49%)
    11 / 52 (21.15%)
         occurrences all number
    13
    11
    Knee Surgery
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Orthopedic Disorder
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    Infections and infestations
    Chest Infection
         subjects affected / exposed
    13 / 51 (25.49%)
    4 / 52 (7.69%)
         occurrences all number
    13
    4
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 52 (1.92%)
         occurrences all number
    1
    1
    Hyperglycaemia and hypoglycaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 52 (5.77%)
         occurrences all number
    1
    3

    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/25043514
    http://www.ncbi.nlm.nih.gov/pubmed/24556343
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