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    Clinical Trial Results:
    Biological standardization of Chenopodium album allergen extract to determine the biological activity in HEP units.

    Summary
    EudraCT number
    		 2012-001937-15
    Trial protocol
    		 ES  
    Global end of trial date
    22 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2022
    First version publication date
    15 May 2022
    Other versions
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    6062-PR-PRI-195
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01675349
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratorios LETI S.L.U.
    Sponsor organisation address
    c/Sol nº 5, Madrid, Spain,
    Public contact
    Departamento Médico, Laboratorios Leti, S.L.U, +34 917711790, clinicalresearch@leti.com
    Scientific contact
    Departamento Médico, Laboratorios Leti, S.L.U, +34 917711790, clinicalresearch@leti.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
    18 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the concentration of Chenopodium album allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.
    Protection of trial subjects
    All subjects included consented to participate in the trial and signed the informed consent form. One copy was given to the patient and the original was kept on file at the research site.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Nov 2012
    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
    Spain: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    48
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Clinical history positive to inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) due to Chenopodium album

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Chenopodium album Prick test
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0,2; 2 y 20 mg/ml

    Investigational medicinal product name
    Histamine Diclorhidrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/ml

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for skin-prick test
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Not applicable

    Number of subjects in period 1
    		Experimental
    Started
    48
    Completed
    23
    Not completed
    25
         Screening failure
    16
         Protocol deviation
    9

    Baseline characteristics

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    End points

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

    Primary: Efficacy

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    End point title
    		 Efficacy [1]
    End point description
    End point type
    Primary
    End point timeframe
    The total duration of the study for a patient was approximately 30 minutes plus at least 30 minutes, under observation in the medical rooms, after the application of the Titrated Skin Prick test.
    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: Statistical analyses is not relevant for published purpose
    End point values
    		 Experimental
    Number of subjects analysed
    23
    Units: mm2
    23
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the clinical trial, adverse events could be spontaneously reported or elicited during open- ended questioning, examination, or evaluation of the patient
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    NK
    Reporting groups
    Reporting group title
    Adverse Events
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse Events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 48 (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
    		 Adverse Events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 48 (2.08%)
    Immune system disorders
    Local reaction
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1

    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
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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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