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    Clinical Trial Results:
    A multicenter, randomized, placebo-controlled, double-blind proof of concept study to evaluate the efficacy and safety of the human normal immunoglobulin Intratect® 5% for intravenous use as adjuvant therapy in patients with Pemphigus Vulgaris

    Summary
    EudraCT number
    		 2013-000211-24
    Trial protocol
    		 DE  
    Global end of trial date
    10 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Mar 2020
    First version publication date
    14 Mar 2020
    Other versions
    Summary report(s)
    		 Statement IMAT-PV 2013-000211-24

    Trial information

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    Trial identification
    Sponsor protocol code
    IMAT-PV
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and Acting Business Director
    Sponsor organisation address
    Im Neuenheimer Feld 672, Heidelberg, Germany, 69120
    Public contact
    Department of Dermatology, University of Heidelberg, +49 6221 5637143, Eva.Hadaschik@med.uni-heidelberg.de
    Scientific contact
    Department of Dermatology, University of Heidelberg, +49 6221 5637143, Eva.Hadaschik@med.uni-heidelberg.de
    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
    10 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The proportion of patients suffering relapse (Relapse rate) during IVIG or placebo treatment within 12 months Relapse: The appearance of ≥ 3 new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions in a patient who has achieved disease control.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2013
    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
    Germany: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    0
    From 65 to 84 years
    99999
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.

    Pre-assignment
    Screening details
    		 N/A

    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
    N/A

    Arms
    Arm title
    		 Intratect
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Intratect 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    N/A

    Number of subjects in period 1
    		Intratect
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    End points

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

    Primary: The proportion of patients suffering relapse (Relapse rate) during IVIG or placebo treatment within 12 months

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    End point title
    		 The proportion of patients suffering relapse (Relapse rate) during IVIG or placebo treatment within 12 months [1]
    End point description
    End point type
    Primary
    End point timeframe
    N/A
    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: Justification: 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial. No statistical analyses for this end point.
    End point values
    		 Intratect
    Number of subjects analysed
    99999 [2]
    Units: N/A
    99999
    Notes
    [2] - No subjects were enrolled in the trial hence results are not available.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events occurring during the course of the clinical trial were to be collected.
    Adverse event reporting additional description
    N/A
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Intratect
    Reporting group description
    		 -

    Serious adverse events
    		 Intratect
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (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
    		 Intratect
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (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: No subjects were enrolled in the trial hence results are not available.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Oct 2013
    Clarifications and responses to subsequent demands of the Ethics Committee

    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.
    No subjects were enrolled in the Trial hence results are not available.
    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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