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    Clinical Trial Results:
    An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis.

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2011-000263-27
    Trial protocol
    		 PL   BG  
    Global end of trial date
    17 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jul 2016
    First version publication date
    24 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IgPro10_4001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01390649
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CSL Behring GmbH
    Sponsor organisation address
    Emil-von-Behring-Strasse 76, Marburg, Germany, 35041
    Public contact
    Clinical Trial Disclosure Manager, CSL Behring, clinicaltrials@cslbehring.com
    Scientific contact
    Clinical Trial Disclosure Manager, CSL Behring, clinicaltrials@cslbehring.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
    19 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study was requested as a post-marketing commitment study by the United States Food and Drug Administration (FDA). The primary objective was to investigate the specificity of in vivo antibody binding to red blood cells in 10 subjects with chronic Immune thrombocytopenic purpura (ITP) who showed signs of hemolysis and who experienced clinically significant intravascular hemolytic reactions following treatment with Privigen. The study was designed to explore potential mechanisms of hemolysis by analysis of the specificity of the antibodies possibly involved.
    Protection of trial subjects
    This study was carried out in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines, applicable international and national regulatory requirements, and standard operating procedures for clinical research and development at CSL Behring. The study protocol and all amendments were approved by the Independent Ethics Committee(s) / Institutional Review Board(s) of the participating centers. Before undergoing screening procedures for possible enrollment into the study, subjects were informed, in an understandable form, about the nature, scope, and possible consequences of the study. The investigator was responsible for obtaining a subject’s written informed consent to participate in the study. The investigator may have ceased study treatment and withdrawn the subject, or the subject may have withdrawn himself from participation in the study at any time. If a subject was withdrawn from the study or further participation was declined, the subject continued to have access to medical care and will be treated according to routine medical practice, but will no longer receive the investigational medicinal product.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2011
    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
    Bulgaria: 7
    Country: Number of subjects enrolled
    Romania: 31
    Country: Number of subjects enrolled
    Serbia: 19
    Worldwide total number of subjects
    57
    EEA total number of subjects
    38
    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)
    55
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening occurred within 6 days before treatment with IgPro10 (Privigen). Subjects who met all of the inclusion criteria and none of the exclusion criteria could be enrolled into the study. Of 58 eligible subjects, 1 withdrew consent before treatment and 57 subjects were treated with Privigen.

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

    Arms
    Arm title
    		 IgPro10
    Arm description
    		 Subjects treated with IgPro10
    Arm type
    		 Experimental

    Investigational medicinal product name
    Privigen®
    Investigational medicinal product code
    IgPro10
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.

    Number of subjects in period 1
    		IgPro10
    Started
    57
    Completed
    56
    Not completed
    1
         Physician decision
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 All subjects who received at least 1 IgPro10 infusion.

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 57 57
    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)
    		 55 55
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.5 ( 13.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 37
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    IgPro10
    Reporting group description
    		 Subjects treated with IgPro10

    Primary: Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis

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    End point title
    		 Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis [1]
    End point description
    The occurrence of clinically significant intravascular hemolysis was determined by an independent Adjudication Committee. No subject experienced clinically significant intravascular hemolysis; therefore, the primary safety endpoint could not be analyzed.
    End point type
    Primary
    End point timeframe
    Within 3 days of infusion
    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: No subject experienced clinically significant intravascular hemolysis; therefore, the primary safety endpoint could not be analyzed.
    End point values
    		 IgPro10
    Number of subjects analysed
    0 [2]
    Units: Antibodies to erythrocytes
    Notes
    [2] - No subject experienced clinically significant intravascular hemolysis; therefore, no analysis made.
    No statistical analyses for this end point

    Secondary: Responder Rate

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    End point title
    		 Responder Rate
    End point description
    The responder rate is the percentage of subjects who have a platelet response (defined as a platelet count increase at least once to ≥ 50 x 10^9/L after the first IgPro10 administration).
    End point type
    Secondary
    End point timeframe
    Within 6 days after the first infusion
    End point values
    		 IgPro10
    Number of subjects analysed
    57
    Units: Percent of subjects
        number (confidence interval 95%)
    74 (61 to 83)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For the duration of individual subject participation in the study, up to approximately 35 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    IgPro10
    Reporting group description
    		 IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.

    Serious adverse events
    		 IgPro10
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 57 (1.75%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Immune Thrombocytopenic Purpura
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IgPro10
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 57 (33.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 57 (29.82%)
         occurrences all number
    23
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Apr 2012
    The main changes to the protocol in this amendment were as follows: - Update of efficacy endpoints towards new EMA guideline from 2010: EMA/CHMP/BPWP/94033/2007 rev. 2 from 22 Jul 2010. Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg). - Updates to revise wording on risks for hemolysis. - Deletion of certain exclusion criteria. - Changes in permitted concomitant medications. - Allowance of re-screening.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    17 Sep 2014
    By September 2014, no case of clinically significant intravascular hemolysis was found, and the Food and Drug Administration (FDA) agreed to halt the study and analyze all hemolysis-relevant endpoints using FDA criteria for hemolysis in addition to analyses planned in the protocol. The study was not restarted.
    -

    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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