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    Clinical Trial Results:
    Training in intralymphatically injection technique. A realistic learning study

    Summary
    EudraCT number
    		 2014-004031-40
    Trial protocol
    		 DK  
    Global end of trial date
    29 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2020
    First version publication date
    16 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Version3.22.11.2014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    ILIT Læringsstudie, Department of Respiratory Diseases, Aarhus University Hospital, 0045 7846 2106 , hans.jurgen.hoffmann@ki.au.dk
    Scientific contact
    ILIT Læringsstudie, Department of Respiratory Diseases, Aarhus University Hospital, 0045 7846 2106 , hans.jurgen.hoffmann@ki.au.dk
    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 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We would like to examine how the new treatment with intralymphatically injections can be learned by doctors with no previous experience in the treatment.
    Protection of trial subjects
    Followed Danish regulations
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 175
    Worldwide total number of subjects
    175
    EEA total number of subjects
    175
    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)
    175
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Allergic rhinoconjunctivits.

    Pre-assignment period milestones
    Number of subjects started
    		 175
    Number of subjects completed
    		 175

    Period 1
    Period 1 title
    Pre-ILIT grass pollen season
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Intervention
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alk 225. Phleum Pratense
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    1000squ. Intralymphatic administration

    Number of subjects in period 1
    		Intervention
    Started
    175
    Completed
    175
    Period 2
    Period 2 title
    Post-ILIT grass pollen season
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Intervention
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alk 225. Phleum Pratense
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    1000squ. Intralymphatic administration

    Number of subjects in period 2
    		Intervention
    Started
    175
    Completed
    175
    Period 3
    Period 3 title
    First injection
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Intervention
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alk 225. Phleum Pratense
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    1000squ. Intralymphatic administration

    Number of subjects in period 3
    		Intervention
    Started
    175
    Completed
    160
    Not completed
    15
         Lost to follow-up
    15
    Period 4
    Period 4 title
    Second injection
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Intervention
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alk 225. Phleum Pratense
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    1000squ. Intralymphatic administration

    Number of subjects in period 4
    		Intervention
    Started
    160
    Completed
    159
    Not completed
    1
         Lost to follow-up
    1
    Period 5
    Period 5 title
    Third Injection
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Intervention
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alk 225. Phleum Pratense
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    1000squ. Intralymphatic administration

    Number of subjects in period 5
    		Intervention
    Started
    159
    Completed
    154
    Not completed
    5
         Lost to follow-up
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pre-ILIT grass pollen season
    Reporting group description
    		 -

    Reporting group values
    		 Pre-ILIT grass pollen season Total
    Number of subjects
    		 175 175
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 175 175
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.2 ± 7.5 -
    Gender categorical
    Units: Subjects
        Female
    		 63 63
        Male
    		 112 112

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -
    Reporting group title
    Intervention
    Reporting group description
    		 -
    Reporting group title
    Intervention
    Reporting group description
    		 -
    Reporting group title
    Intervention
    Reporting group description
    		 -
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Primary: Injection score

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    End point title
    		 Injection score
    End point description
    End point type
    Primary
    End point timeframe
    First, second and third injection.
    End point values
    		 Intervention Intervention Intervention
    Number of subjects analysed
    160
    159
    154
    Units: 1
        arithmetic mean (standard deviation)
    3.3 ± 0.7
    3.2 ± 0.8
    3.3 ± 0.6
    Statistical analysis title
    		 Injection score
    Comparison groups
    Intervention v Intervention v Intervention
    Number of subjects included in analysis
    473
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.12 [1]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Variability estimate
    Standard deviation
    Dispersion value
    1
    Notes
    [1] - Anova p value 0.12. Parameter estimates not calculated and reported below are fictive numbers.

    Secondary: cSMS

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    End point title
    		 cSMS
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-ILIT to post-ILIT
    End point values
    		 Intervention Intervention
    Number of subjects analysed
    157
    157
    Units: 1
    arithmetic mean (confidence interval 95%)
        csms
    1.56 (1.53 to 1.77)
    1.00 (0.89 to 1.12)
    Statistical analysis title
    		 pre-post cSMS
    Comparison groups
    Intervention v Intervention
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 0.76
    Variability estimate
    Standard deviation
    Dispersion value
    0.67

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Serious adverse events
    		 Intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 175 (0.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 175 (48.57%)
    Immune system disorders
    Local reaction
         subjects affected / exposed
    85 / 175 (48.57%)
         occurrences all number
    125

    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/33099797
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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
    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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