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    Clinical Trial Results:
    Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study

    Summary
    EudraCT number
    		 2016-001638-84
    Trial protocol
    		 NL  
    Global end of trial date
    01 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jan 2020
    First version publication date
    07 Jan 2020
    Other versions
    Summary report(s)
    		 Summary ThiLDA study (abstract) EudraCT

    Trial information

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    Trial identification
    Sponsor protocol code
    16-07
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Meander medical center
    Sponsor organisation address
    Maatweg 3, Amersfoort, Netherlands, 3813 TZ
    Public contact
    SF Chavoushi, Meander Medical Center, 0031 612928800, faraz.chavoushi@gmail.com
    Scientific contact
    SF Chavoushi, Meander Medical Center, 0031 612928800, faraz.chavoushi@gmail.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
    01 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigating whether 50 mg allopurinol is non-inferior to 100 mg in combination with azathioprine or mercaptopurine by measuring and comparing thiopurine metabolites
    Protection of trial subjects
    trial subjects were seen every few weeks (AND during 'regular clinical' follow-up visits)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2016
    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: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 study subjects were recruited by using existing the electronic records database. patients were called, informed and asked to participate (and, before participating, sign an informed consent form)

    Pre-assignment
    Screening details
    		 study subjects were recruited by using existing the electronic records database, and by using the inclusion and exclusion criteria

    Period 1
    Period 1 title
    control (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    none

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 one way crossover group
    Arm description
    		 one way crossover group (22 patients in total group, and in reality there was only ONE arm/group! We had to add two arms in EudraCT because of a million errors that we get due to a faulty website which does not let us proceed with only one arm...)
    Arm type
    		 single arm (one way crossover)

    Investigational medicinal product name
    Allopurinol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg and 50 mg: at start of the intervention (=switch from 100mg to 50 mg tablets) the 100 mg tablets will be splitted/divided in two pieces by using a pill splitter and the existing scoring ('dividing') line on the 100 mg tablet

    Arm title
    		 one way crossover (same group, total = 22)
    Arm description
    		 one way crossover group (22 patients in total group, and in reality there was only ONE arm/group! We had to add two arms in EudraCT because of a million errors that we get due to a faulty website which does not let us proceed with only one arm...)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allopurinol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg and 50 mg: at start of the intervention (=switch from 100mg to 50 mg tablets) the 100 mg tablets will be splitted/divided in two pieces by using a pill splitter and the existing scoring ('dividing') line on the 100 mg tablet

    Number of subjects in period 1
    		one way crossover group one way crossover (same group, total = 22)
    Started
    11
    11
    start
    11
    11
    used allopurinol 50 mg for at least 30d
    11
    11
    finished
    11
    11
    Completed
    11
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    control
    Reporting group description
    		 one-way crossover group

    Reporting group values
    		 control Total
    Number of subjects
    		 22 22
    Age categorical
    Units: Subjects
    Age continuous
    all subjects were >18 years of age
    Units: years
        arithmetic mean (standard deviation)
    		 38.3 ± 7 -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    one way crossover group
    Reporting group description
    		 one way crossover group (22 patients in total group, and in reality there was only ONE arm/group! We had to add two arms in EudraCT because of a million errors that we get due to a faulty website which does not let us proceed with only one arm...)

    Reporting group title
    one way crossover (same group, total = 22)
    Reporting group description
    		 one way crossover group (22 patients in total group, and in reality there was only ONE arm/group! We had to add two arms in EudraCT because of a million errors that we get due to a faulty website which does not let us proceed with only one arm...)

    Primary: thiopurine metabolite concentrations (6-TGN)

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    End point title
    		 thiopurine metabolite concentrations (6-TGN)
    End point description
    End point type
    Primary
    End point timeframe
    before/after intervention
    End point values
    		 one way crossover group one way crossover (same group, total = 22)
    Number of subjects analysed
    11
    11 [1]
    Units: pmol/8*108 RBC
    arithmetic mean (standard deviation)
        before intervention
    761 ± 0
    761 ± 0
        after intervention
    625 ± 0
    625 ± 0
    Notes
    [1] - 22 patients in total group, and in reality there was only ONE arm/group! (faulty EudraCT website!)
    Statistical analysis title
    		 metabolite conc statistical analysis
    Statistical analysis description
    paired t-test
    Comparison groups
    one way crossover group v one way crossover (same group, total = 22)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.005
    Method
    		 paired t-test
    Parameter type
    		 Mean difference (net)
    Point estimate
    -136
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -227.5
         upper limit
    		 -45.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Notes
    [2] - paired t-test

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    during trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 patient's doctor
    Dictionary version
    1
    Reporting groups
    Reporting group title
    one way crossover group
    Reporting group description
    		 one way crossover group

    Serious adverse events
    		 one way crossover group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 one way crossover group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: 13 patients experienced AEs after intervention. 3 of those subjects experienced fatigue (please see full paper for all reported AEs and further details). Also there were 22 patients in total group, and in reality there was only ONE arm/group! (could not proceed with just one single arm due to faulty EudraCT website!)

    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.
    n/a

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31587102
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