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    Clinical Trial Results:
    A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTICENTER CLINICAL TRIAL ON HOME PARENTERAL NUTRITION USING AN OMEGA-3 FATTY ACID ENRICHED MCT/LCT LIPID EMULSION

    Summary
    EudraCT number
    		 2015-000849-23
    Trial protocol
    		 NL   GB  
    Global end of trial date
    19 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Aug 2023
    First version publication date
    10 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HC-G-H-1403
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03282955
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    B. Braun Melsungen AG, Division Hospital Care
    Sponsor organisation address
    Carl-Braun-Straße 1, Melsungen, Germany, 34212
    Public contact
    Medical Scientific Affairs Hospital Care / Clinical Development, B. Braun Melsungen AG, studies@bbraun.com
    Scientific contact
    Medical Scientific Affairs Hospital Care / Clinical Development, B. Braun Melsungen AG, studies@bbraun.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
    07 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure (CIF) in need of long-term home parenteral nutrition (HPN). It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.
    Protection of trial subjects
    The study was performed in accordance with the ethical principles that have their origin in the “Declaration of Helsinki” and its amendments in force at the time of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jan 2018
    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
    Netherlands: 7
    Country: Number of subjects enrolled
    Poland: 38
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    France: 21
    Country: Number of subjects enrolled
    Italy: 5
    Worldwide total number of subjects
    74
    EEA total number of subjects
    71
    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)
    61
    From 65 to 84 years
    12
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient in: 08JAN2018 Last patient out: 24MAY2022 Decision to terminate the study early was taken on 19 July 2022 due to unsufficient recruitment. Eleven initiated sites in PL, IT, NL, UK and F, of which 9 sites successfully enrolled patients and contributed to the analyses.

    Pre-assignment
    Screening details
    		 A total of 74 patients were screened (All Patient Screened Set) and enrolled (Intention-to-treat Set, ITT). 2 patients were not exposed to IP and are therefore excluded from all patients treated set (APTS, safety set).

    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
    Blinded IP was provided to those investigational sites where the patient added lipid to the PN by him/herself. In those study sites where either the hospital pharmacy or a compounding unit (CU) prepared AIO PN-admixtures including the IP as the lipid part, unblinded IP was delivered to the pharmacy/ CU. The independent statistician provided randomization envelopes to the unblinded pharmacist for treatment allocation. The label of the AIO admixture did not show any unblinding information.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test group
    Arm description
    		 Omega-3 FA enriched LE Lipidem as lipid component of PN
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lipidem® 200 mg/ml
    Investigational medicinal product code
    Other name
    Lipoplus®
    Pharmaceutical forms
    Emulsion for infusion
    Routes of administration
    Infusion , Intravenous use
    Dosage and administration details
    The IPs were delivered as the lipid part of the PN. Besides the lipid, PN contained glucose, amino acids, electrolytes, trace elements and vitamins and were administered according to the individual patient’s normal prescription. To be eligible for the study, a patient’s prescription should have included a weekly lipid dose of at least 3.0 g lipid per kg (BW).

    Arm title
    		 Control group
    Arm description
    		 Lipofundin MCT as lipid component of PN
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lipofundin MCT
    Investigational medicinal product code
    Other name
    Medialipide
    Pharmaceutical forms
    Emulsion for infusion
    Routes of administration
    Infusion , Intravenous use
    Dosage and administration details
    The IPs were delivered as the lipid part of the PN. Besides the lipid, PN contained glucose, amino acids, electrolytes, trace elements and vitamins and were administered according to the individual patient’s normal prescription. To be eligible for the study, a patient’s prescription should have included a weekly lipid dose of at least 3.0 g lipid per kg (BW).

    Number of subjects in period 1 [1]
    		Test group Control group
    Started
    38
    34
    Completed
    36
    31
    Not completed
    2
    3
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    1
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 2 subjects had been enrolled, but they have not been treated and were therefore not included in the safety and efficacy analyses population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test group
    Reporting group description
    		 Omega-3 FA enriched LE Lipidem as lipid component of PN

    Reporting group title
    Control group
    Reporting group description
    		 Lipofundin MCT as lipid component of PN

    Reporting group values
    		 Test group Control group Total
    Number of subjects
    		 38 34 72
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 31 28 59
        From 65-84 years
    		 6 6 12
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.13 ± 15.82 52.44 ± 15.50 -
    Gender categorical
    Units: Subjects
        Female
    		 22 10 32
        Male
    		 16 24 40
    Pathological Classification of Intestinal failure
    Units: Subjects
        Short bowel syndrome
    		 26 24 50
        Intestinal dysmotility
    		 6 6 12
        Intestinal fistula
    		 3 3 6
        Mechanical obstruction
    		 2 0 2
        Extensive small bowel mucosal disease
    		 1 1 2
    Underlying Disease of chronic intestinal failure
    Units: Subjects
        Surgical complications
    		 8 6 14
        Mesenteric ischemia
    		 8 5 13
        Crohn´s disease
    		 7 5 12
        Primary chronic intestinal pseudo-obstruction
    		 3 3 6
        Secondary chronic intestinal pseudo-obstruction
    		 0 4 4
        Radiation enteritis
    		 1 3 4
        Adhesions
    		 2 1 3
        Volvulus
    		 0 2 2
        Other
    		 9 5 14
    Subject analysis sets

    Subject analysis set title
    All Patients Treated Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients enrolled in the study (irrespective of the compliance with the planned treatment regimen) identical to all patients of the ITT set who received at least one dose of the trial medication. This was used as Safety Set.

    Subject analysis sets values
    		 All Patients Treated Set
    Number of subjects
    72
    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)
    59
        From 65-84 years
    12
        85 years and over
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.22 ± 15.6
    Gender categorical
    Units: Subjects
        Female
    32
        Male
    40
    Pathological Classification of Intestinal failure
    Units: Subjects
        Short bowel syndrome
    50
        Intestinal dysmotility
    12
        Intestinal fistula
    6
        Mechanical obstruction
    2
        Extensive small bowel mucosal disease
    2
    Underlying Disease of chronic intestinal failure
    Units: Subjects
        Surgical complications
    14
        Mesenteric ischemia
    13
        Crohn´s disease
    12
        Primary chronic intestinal pseudo-obstruction
    6
        Secondary chronic intestinal pseudo-obstruction
    4
        Radiation enteritis
    4
        Adhesions
    3
        Volvulus
    2
        Other
    14

    End points

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    End points reporting groups
    Reporting group title
    Test group
    Reporting group description
    		 Omega-3 FA enriched LE Lipidem as lipid component of PN

    Reporting group title
    Control group
    Reporting group description
    		 Lipofundin MCT as lipid component of PN

    Subject analysis set title
    All Patients Treated Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients enrolled in the study (irrespective of the compliance with the planned treatment regimen) identical to all patients of the ITT set who received at least one dose of the trial medication. This was used as Safety Set.

    Primary: Change of liver function parameters defined as the sum of the N(0,1)-transformed differences in bilirubin (BILI), alanine transaminase (ALT) and aspartate transaminase (AST) from Baseline (BL) to V2

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    End point title
    		 Change of liver function parameters defined as the sum of the N(0,1)-transformed differences in bilirubin (BILI), alanine transaminase (ALT) and aspartate transaminase (AST) from Baseline (BL) to V2
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks on average upt to 12 weeks (from BL to V2)
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    30
    Units: unknown
        arithmetic mean (standard deviation)
    0.0223 ± 3.0816
    -0.0260 ± 1.8287
    Statistical analysis title
    		 Non-inferiority test for the primary outcome
    Statistical analysis description
    Non-inferiority Test for the Primary Outcome - Sum of Changes of Three Liver Function Parameters in the VCAS
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.9404
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2353
         upper limit
    		 1.3318
    Variability estimate
    Standard deviation
    Dispersion value
    2.5815
    Notes
    [1] - The test procedure to show non-inferiority was a one-sided two-sample t-test (α-level: 0.025) for mean differences assuming equal variances and normality. The non-inferiority margin was defined as 1.151. The 2-sided confidence intervall was chosen to provide an upper and lower limit for the point estimate.

    Secondary: Total BILI, change from BL to V2

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    End point title
    		 Total BILI, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    30
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    0.15 ± 3.14
    0.04 ± 3.32
    No statistical analyses for this end point

    Secondary: ALT, change from BL to V2

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    End point title
    		 ALT, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Change form Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    30
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    0.01 ± 0.53
    -0.01 ± 0.23
    No statistical analyses for this end point

    Secondary: AST, change from BL to V2

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    End point title
    		 AST, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    30
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    -0.03 ± 0.38
    -0.02 ± 0.19
    No statistical analyses for this end point

    Secondary: Conjugated Bilirubin, change from BL to V2

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    End point title
    		 Conjugated Bilirubin, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    31
    29
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    0.72 ± 3.10
    -0.04 ± 1.57
    No statistical analyses for this end point

    Secondary: AST/ALT, change from BL to V2

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    End point title
    		 AST/ALT, change from BL to V2
    End point description
    De Ritis quotient
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    31
    Units: quotient
        arithmetic mean (standard deviation)
    0.53 ± 1.00
    0.89 ± 2.52
    No statistical analyses for this end point

    Secondary: ALP, change from BL to V2

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    End point title
    		 ALP, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    30
    Units: microkat/litre
        arithmetic mean (standard deviation)
    0.13 ± 0.66
    -0.15 ± 1.46
    No statistical analyses for this end point

    Secondary: GGT, change from BL to V2

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    End point title
    		 GGT, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    30
    Units: microkat/litre
        arithmetic mean (standard deviation)
    0.02 ± 0.38
    -0.11 ± 1.64
    No statistical analyses for this end point

    Secondary: WBC, change from BL to V2

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    End point title
    		 WBC, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    31
    Units: 10^9/litre
        arithmetic mean (standard deviation)
    0.45 ± 1.42
    0.19 ± 1.39
    No statistical analyses for this end point

    Secondary: RBC, change from BL to V2

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    End point title
    		 RBC, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    31
    Units: 10^12/litre
        arithmetic mean (standard deviation)
    -0.02 ± 0.28
    -0.10 ± 0.28
    No statistical analyses for this end point

    Secondary: Haemoglobin, change from BL to V2

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    End point title
    		 Haemoglobin, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    31
    Units: gram(s)/litre
        arithmetic mean (standard deviation)
    0.52 ± 8.82
    -1.75 ± 8.22
    No statistical analyses for this end point

    Secondary: Haematocrit, change from BL to V2

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    End point title
    		 Haematocrit, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    31
    Units: Litre/litre
        arithmetic mean (standard deviation)
    -0.00 ± 0.03
    -0.01 ± 0.03
    No statistical analyses for this end point

    Secondary: Platelets, change from BL to V2

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    End point title
    		 Platelets, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    31
    Units: 10^9/litre
        arithmetic mean (standard deviation)
    3.06 ± 41.11
    6.9 ± 50.33
    No statistical analyses for this end point

    Secondary: INR, change from BL to V2

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    End point title
    		 INR, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    27
    25
    Units: ratio
        arithmetic mean (standard deviation)
    -0.01 ± 0.25
    -0.16 ± 0.71
    No statistical analyses for this end point

    Secondary: Prothrombin Time, change from BL to V2

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    End point title
    		 Prothrombin Time, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    6
    3
    Units: second
        arithmetic mean (standard deviation)
    -0.80 ± 1.15
    1.27 ± 5.16
    No statistical analyses for this end point

    Secondary: Activated partial thromboplastine time (ratio), change from BL to V2

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    End point title
    		 Activated partial thromboplastine time (ratio), change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    9
    9
    Units: Ratio
        arithmetic mean (standard deviation)
    -0.02 ± 0.12
    -0.04 ± 0.16
    No statistical analyses for this end point

    Secondary: Activated partial thromboplastin time (s), change from BL to V2

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    End point title
    		 Activated partial thromboplastin time (s), change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    25
    19
    Units: second
        arithmetic mean (standard deviation)
    0.02 ± 3.85
    0.97 ± 7.69
    No statistical analyses for this end point

    Secondary: Triene:tetraene ratio (plasma), change from BL to V2

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    End point title
    		 Triene:tetraene ratio (plasma), change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    27
    Units: Ratio
        arithmetic mean (standard deviation)
    -0.011 ± 0.024
    -0.008 ± 0.028
    No statistical analyses for this end point

    Secondary: Triene:tetraene ratio (RBC), change from BL to V2

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    End point title
    		 Triene:tetraene ratio (RBC), change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    27
    Units: Ratio
        arithmetic mean (standard deviation)
    0.000 ± 0.004
    -0.001 ± 0.004
    No statistical analyses for this end point

    Secondary: Eicosapentaenoic acid, change from BL to V2

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    End point title
    		 Eicosapentaenoic acid, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    27
    Units: percent
        median (inter-quartile range (Q1-Q3))
    1.60 (0.53 to 2.38)
    0.02 (-0.12 to 0.12)
    No statistical analyses for this end point

    Secondary: Docosahexaenoic acid, change from BL to V2

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    End point title
    		 Docosahexaenoic acid, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    27
    Units: percent
        median (inter-quartile range (Q1-Q3))
    1.47 (0.51 to 2.08)
    -0.02 (-0.35 to 0.10)
    No statistical analyses for this end point

    Secondary: BMI, change from BL to V2

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    End point title
    		 BMI, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    36
    31
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    0.4 ± 0.7
    0.2 ± 0.7
    No statistical analyses for this end point

    Secondary: EQ-5D-5L Health State Score, change from BL to V2

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    End point title
    		 EQ-5D-5L Health State Score, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    36
    34
    Units: points
        arithmetic mean (standard deviation)
    -0.00 ± 0.14
    0.01 ± 0.11
    No statistical analyses for this end point

    Secondary: EQ-VAS, change from BL to V2

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    End point title
    		 EQ-VAS, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    36
    31
    Units: score
        arithmetic mean (standard deviation)
    4.28 ± 14.21
    2.29 ± 13.19
    No statistical analyses for this end point

    Secondary: Blood glucose, change from BL to V2

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    End point title
    		 Blood glucose, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    32
    31
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    0.43 ± 0.94
    -0.14 ± 1.33
    No statistical analyses for this end point

    Secondary: Sodium, change from BL to V2

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    End point title
    		 Sodium, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    31
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    0.18 ± 2.67
    -0.58 ± 2.74
    No statistical analyses for this end point

    Secondary: Chloride, change from BL to V2

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    End point title
    		 Chloride, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    31
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    -0.19 ± 3.33
    -0.15 ± 4.08
    No statistical analyses for this end point

    Secondary: Potassium, change from BL to V2

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    End point title
    		 Potassium, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    31
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    0.06 ± 0.37
    0.01 ± 0.46
    No statistical analyses for this end point

    Secondary: Calcium, change from BL to V2

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    End point title
    		 Calcium, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    31
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    -0.01 ± 0.15
    -0.01 ± 0.10
    No statistical analyses for this end point

    Secondary: Magnesium, change from BL to V2

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    End point title
    		 Magnesium, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    30
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    0.00 ± 0.09
    -0.00 ± 0.06
    No statistical analyses for this end point

    Secondary: Phosphate, change from BL to V2

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    End point title
    		 Phosphate, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    34
    30
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    -0.02 ± 0.18
    -0.00 ± 0.16
    No statistical analyses for this end point

    Secondary: Serum creatinine, change from BL to V2

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    End point title
    		 Serum creatinine, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    31
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    3.87 ± 32.42
    0.43 ± 9.23
    No statistical analyses for this end point

    Secondary: Triglyceride, change from BL to V2

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    End point title
    		 Triglyceride, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    36
    30
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    0.10 ± 0.55
    0.19 ± 0.68
    No statistical analyses for this end point

    Secondary: Cholesterol, change from BL to V2

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    End point title
    		 Cholesterol, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    36
    30
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    0.01 ± 0.39
    0.02 ± 0.71
    No statistical analyses for this end point

    Secondary: High-density lipoprotein, change from BL to V2

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    End point title
    		 High-density lipoprotein, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    36
    30
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    -0.12 ± 0.19
    0.03 ± 0.23
    No statistical analyses for this end point

    Secondary: Low-density lipoprotein, change from BL to V2

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    End point title
    		 Low-density lipoprotein, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    36
    30
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    0.07 ± 0.33
    -0.08 ± 0.76
    No statistical analyses for this end point

    Secondary: C-reactive protein, change from BL to V2

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    End point title
    		 C-reactive protein, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    35
    30
    Units: nanomole(s)/litre
        arithmetic mean (standard deviation)
    37.16 ± 160.03
    -24.65 ± 209.18
    No statistical analyses for this end point

    Secondary: alpha-Tocopherol, change from BL to V2

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    End point title
    		 alpha-Tocopherol, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    4
    5
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    -3.00 ± 6.60
    -1.94 ± 10.99
    No statistical analyses for this end point

    Secondary: Vitamin E, change from BL to V2

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    End point title
    		 Vitamin E, change from BL to V2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Visit 2
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    10
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    2.30 ± 4.97
    3.81 ± 7.18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    08-Jan-2018 - 19-Jul-2022
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Lipidem
    Reporting group description
    		 Test Group

    Reporting group title
    Lipofundin MCT
    Reporting group description
    		 Control Group

    Serious adverse events
    		 Lipidem Lipofundin MCT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 38 (13.16%)
    3 / 34 (8.82%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 34 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermo-hypodermitis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site infection
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device breakage
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         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
    		 Lipidem Lipofundin MCT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 38 (39.47%)
    12 / 34 (35.29%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Product issues
    Device infusion issue
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 38 (7.89%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    Paraesthesia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 38 (7.89%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    Abdominal pain
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Intestinal pseudo-obstruction
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Breast abscess
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Laryngitis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Lymphangitis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Tracheitis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jul 2017
    Substantial amendment 1.0: The exclusion criterion No. 4 was amended to harmonize the information about the contraindication between SmPC and Study Protocol, i.e., exclusion of patients with hypersensitivity for peanut. The exclusion criterion No. 16 was added to fulfil the requirements of the French Independent Ethics Committee concerning exclusion of persons of legal age who are the subject of a legal protection measure or who are unable to express their consent.
    06 Nov 2019
    Substantial amendment 4.0: Change of inclusion criterion “Patients with chronic intestinal failure receiving HPN including lipids in whom the parenteral macronutrients have not been changed by more than 10% for at least 3 months” in order to facilitate patient 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.
    The study remains underpowered due to insufficient recruitment.
    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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