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    Clinical Trial Results:
    Liposomal amphotericin B (Ambisome) pharmacokinetics given as a single intravenous dose to obese patients (ASPEN).

    Summary
    EudraCT number
    		 2014-003306-33
    Trial protocol
    		 NL  
    Global end of trial date
    03 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2020
    First version publication date
    26 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UMCN-AKF-14.04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
    Public contact
    Roger Brüggemann, Radboud university medical center, +31 243616405, roger.bruggemann@radboudumc.nl
    Scientific contact
    Roger Brüggemann, Radboud university medical center, +31 243616405, roger.bruggemann@radboudumc.nl
    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
    01 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To determine the pharmacokinetics of liposomal amphotericin B administered as a single, intravenous dose (2 mg/kg or 3 mg/kg) to obese patients with a BMI ≥ 40 kg/m2.
    Protection of trial subjects
    The risks for participating in this study are considered to be minimal. There are no direct benefits of this study for the study patients. The results of the study will provide insight into the pharmacokinetics of AmBisome in morbidly obese patients. The first group of patients will receive a lower dose of 1 mg/kg. An interim analysis of the safety profile of the first group will be performed by the study team before proceeding to the 2 mg/kg dose group. The dosages in our trial design (1 mg/kg and 2 mg/kg) are lower than the recommended dose by the manufacturer of 5 mg/kg (for treatment of invasive fungal infections caused by Aspergillus-species. Guidelines (ECIL, IDSA, SWAB) suggest 3 mg/kg for this indication) and 10 mg/kg used in Mucor species infections. Furthermore, the maximum tolerated dosage of AmBisome exceeds 15 mg/kg per day and was considered well tolerated.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Mar 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: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 morbidly obese but otherwise healthy adults with a body mass index (BMI >40 kg/m2) the day before they underwent bariatric surgery.

    Period 1
    Period 1 title
    screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    nap

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 1 mg/kg group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    AmBisome
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    no dose at screening

    Arm title
    		 2 mg/kg group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    AmBisome
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    no dose at screening

    Number of subjects in period 1
    		1 mg/kg group 2 mg/kg group
    Started
    8
    8
    Completed
    8
    8
    Period 2
    Period 2 title
    PK curve period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ambisome 1mg/kg
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    AmBisome
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1mg/kg ambisome IV single dose

    Arm title
    		 2 mg/kg ambisome
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    AmBisome
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2mg/kg ambisome IV single dose

    Number of subjects in period 2
    		ambisome 1mg/kg 2 mg/kg ambisome
    Started
    8
    8
    Completed
    8
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1 mg/kg group
    Reporting group description
    		 -

    Reporting group title
    2 mg/kg group
    Reporting group description
    		 -

    Reporting group values
    		 1 mg/kg group 2 mg/kg group Total
    Number of subjects
    		 8 8 16
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 34 (21 to 56) 39 (27 to 63) -
    Gender categorical
    Units: Subjects
        Female
    		 7 5 12
        Male
    		 1 3 4

    End points

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    End points reporting groups
    Reporting group title
    1 mg/kg group
    Reporting group description
    		 -

    Reporting group title
    2 mg/kg group
    Reporting group description
    		 -
    Reporting group title
    ambisome 1mg/kg
    Reporting group description
    		 -

    Reporting group title
    2 mg/kg ambisome
    Reporting group description
    		 -

    Primary: AUC

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    End point title
    		 AUC [1]
    End point description
    End point type
    Primary
    End point timeframe
    24h, no acutal AUCs were generated. PopPK model was generated. AUC values reported here are relative
    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: not done, the results of this study do not fit into the template for reporting
    End point values
    		 ambisome 1mg/kg 2 mg/kg ambisome
    Number of subjects analysed
    8
    8
    Units: mg*h/L
        geometric mean (geometric coefficient of variation)
    1 ( 37 )
    2 ( 37 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    entire study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    1
    Reporting groups
    Reporting group title
    all subjects
    Reporting group description
    		 -

    Serious adverse events
    		 all subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 all subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 16 (87.50%)
    General disorders and administration site conditions
    red, warm skin
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    ache
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    hypertensia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    hot flushes
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    muscle ache
         subjects affected / exposed
    13 / 16 (81.25%)
         occurrences all number
    14

    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/31588493
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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