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    Clinical Trial Results:
    A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes.

    Summary
    EudraCT number
    		 2013-000620-34
    Trial protocol
    		 IT   HU   DE   GB  
    Global end of trial date
    14 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2016
    First version publication date
    18 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IGSC-1103
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LFB Biotechnologies
    Sponsor organisation address
    3 avenue des Tropiques - BP 40305 - LES ULIS, COUTABOEUF CEDEX, France, 91930
    Public contact
    Global Clinical Development Leader, LFB Biotechnologies, +33 169825656,
    Scientific contact
    Global Clinical Development Leader, LFB Biotechnologies, +33 169825656,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001290-PIP01-12
    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
    17 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Mar 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the efficacy of LFB-IgSC.
    Protection of trial subjects
    The following non-inclusion criteria were aimed to avoid or minimise some potentially serious adverse reactions that have been described with immunoglobulins: • Patients with known anti-IgA antibodies will be excluded. Patients with history of severe allergic reaction to any IVIg, SCIg or an excipient of LFB-IgSC should not be included. • Patients aged over 70 or with a history of cardiac ischemia, cerebral ischemia, stroke, thrombotic episodes or pulmonary embolism should not be included. • Patients with renal insufficiency (glomerular filtration rate < 80 ml/min/1.73m2) should not be included. A Data and Safety Monitoring Board was set-up to evaluate the safety data of the first 3 administrations in the first 5 adult patients and provide recommendations on whether to proceed with the inclusion of the following patients, including the paediatric population subset.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Oct 2013
    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
    France: 2
    Country: Number of subjects enrolled
    Hungary: 4
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    5
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 24 October 2013 and 5 November 2013, 6 adult patients signed an informed consent form at 3 investigational sites.

    Pre-assignment
    Screening details
    		 All the screened patients (i.e. 6 adult patients) have been included and have received the study drug.

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

    Arms
    Arm title
    		 Single arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    LFB-IGSC
    Investigational medicinal product code
    LFB-IGSC
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    LFB-IgSC is a solution of human normal immunoglobulin for subcutaneous infusion, concentrated at 250 mg/ml.

    Number of subjects in period 1
    		Single arm
    Started
    6
    Completed
    6
    Period 2
    Period 2 title
    Treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Single arm
    Arm description
    		 LFB-IgSC was administered once a week, at regular intervals of 7 days ± 1 day. The administered dose was be equivalent to the dose received by the patients before the study. In other words, the weekly dose of LFB-IgSC was calculated as follows: • Patients who previously received IVIg infusions every 4 weeks, received a quarter of their IV infusion dose • Patients who previously received IVIg infusions every 3 weeks, received a third of their IV infusion dose • Patients who previously received SCIg weekly, received the same dose of LFB-IgSC
    Arm type
    		 Experimental

    Investigational medicinal product name
    LFB-IGSC
    Investigational medicinal product code
    LFB-IGSC
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    LFB-IgSC is a solution of human normal immunoglobulin for subcutaneous infusion, concentrated at 250 mg/ml.

    Number of subjects in period 2
    		Single arm
    Started
    6
    Completed
    0
    Not completed
    6
         Adverse event, non-fatal
    2
         Study premature termination for safety reason
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        Adults 18-70 years
    		 6 6
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 46 (25 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 2 2
    Subject analysis sets

    Subject analysis set title
    Total treated set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Descriptive analysis

    Subject analysis sets values
    		 Total treated set
    Number of subjects
    6
    Age categorical
    Units: Subjects
        Adults 18-70 years
    6
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    46 (25 to 69)
    Gender categorical
    Units: Subjects
        Female
    4
        Male
    2

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 -
    Reporting group title
    Single arm
    Reporting group description
    		 LFB-IgSC was administered once a week, at regular intervals of 7 days ± 1 day. The administered dose was be equivalent to the dose received by the patients before the study. In other words, the weekly dose of LFB-IgSC was calculated as follows: • Patients who previously received IVIg infusions every 4 weeks, received a quarter of their IV infusion dose • Patients who previously received IVIg infusions every 3 weeks, received a third of their IV infusion dose • Patients who previously received SCIg weekly, received the same dose of LFB-IgSC

    Subject analysis set title
    Total treated set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Descriptive analysis

    Primary: number of serious bacterial infections (SBI)

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    End point title
    		 number of serious bacterial infections (SBI) [1]
    End point description
    No SBI was observed during the study. However, this result is of limited value due to the low number of included patients and the short duration of patient follow-up. The 98% confidence interval of the rate of SBI per patient and per year is [0.00 – 2.94].
    End point type
    Primary
    End point timeframe
    from November 2013 to March 2014
    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: Descriptive analyses
    End point values
    		 Total treated set
    Number of subjects analysed
    6
    Units: SBI per patient and per year
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From November 2013 to March 2014
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 -

    Serious adverse events
    		 Single arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    infusion site reaction
    Additional description: Ulcerated skin lesions at the infusion site
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Single arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    11
    General disorders and administration site conditions
    Infusion site reaction
    Additional description: Infusion site reactions were made of one or several signs/symptoms, including swelling, erythema, nodule, pruritus, pain, hematoma, papule, vesicle, ulcer, necrosis, discoloration.
         subjects affected / exposed
    6 / 6 (100.00%)
         occurrences all number
    155

    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? Yes
    Date
    Interruption
    Restart date
    14 Mar 2014
    In early March 2014, LFB made the decision to prematurely stop the study due to adverse local reactions. The last visit of the last patient was performed on 14 March 2014.
    -

    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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