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    Clinical Trial Results:
    A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases

    Summary
    EudraCT number
    		 2013-002290-21
    Trial protocol
    		 GB   HU  
    Global end of trial date
    13 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Apr 2017
    First version publication date
    22 Apr 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GMX07
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01963143
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bio Products Laboratory Limited
    Sponsor organisation address
    Dagger Lane, Elstree, United Kingdom, WD6 3BX
    Public contact
    Head of Medical Affairs, Bio Products Laboratory Limited, 44 2089572200, medinfo@bpl.co.uk
    Scientific contact
    Head of Medical Affairs, Bio Products Laboratory Limited, 44 2089572200, medinfo@bpl.co.uk
    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
    13 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the bioequivalence of Gammaplex® 10 (Gammaplex® [10%] 10 g in 100 mL) intravenous immunoglobulin (IGIV) and Gammaplex® 5% (Gammaplex® [5%] 5 g in 100 mL) IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of adult subjects.
    Protection of trial subjects
    The number of PK samples was the minimum number required to provide an evaluable PK profile.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jan 2014
    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
    United Kingdom: 3
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    United States: 44
    Worldwide total number of subjects
    48
    EEA total number of subjects
    4
    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)
    9
    Adolescents (12-17 years)
    8
    Adults (18-64 years)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects underwent screening assessments within 30 days before first dose of Gammaplex 5% or Gammaplex 10%

    Period 1
    Period 1 title
    All subjects (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gammaplex 5% & Gammaplex 10% on a 21-day treatment schedule
    Arm description
    		 Adult subjects aged 16+ years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gammaplex 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All subjects were to receive a dose of 300 to 800 mg/kg/infusion. Subjects were to receive the same dose as per their prior IGIV. Infusions were administered on either a 21-day or 28-day treatment schedule, depending on the subject's cycle of infusions during prior IGIV treatment. Subjects were randomised to receive either 5 infusions of Gammaplex 5% followed by 5 infusions of Gammaplex 10%, or 5 infusions of Gammaplex 10% followed by 5 infusions of Gammaplex 5%.

    Investigational medicinal product name
    Gammaplex 10%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All subjects were to receive a dose of 300 to 800 mg/kg/infusion. Subjects were to receive the same dose as per their prior IGIV. Infusions were administered on either a 21-day or 28-day treatment schedule, depending on the subject's cycle of infusions during prior IGIV treatment. Subjects were randomised to receive either 5 infusions of Gammaplex 5% followed by 5 infusions of Gammaplex 10%, or 5 infusions of Gammaplex 10% followed by 5 infusions of Gammaplex 5%.

    Arm title
    		 Gammaplex 5% & Gammaplex 10% on a 28-day treatment schedule
    Arm description
    		 Adult subjects aged 16+ years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gammaplex 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All subjects were to receive a dose of 300 to 800 mg/kg/infusion. Subjects were to receive the same dose as per their prior IGIV. Infusions were administered on either a 21-day or 28-day treatment schedule, depending on the subject's cycle of infusions during prior IGIV treatment. Subjects were randomised to receive either 5 infusions of Gammaplex 5% followed by 5 infusions of Gammaplex 10%, or 5 infusions of Gammaplex 10% followed by 5 infusions of Gammaplex 5%.

    Investigational medicinal product name
    Gammaplex 10%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All subjects were to receive a dose of 300 to 800 mg/kg/infusion. Subjects were to receive the same dose as per their prior IGIV. Infusions were administered on either a 21-day or 28-day treatment schedule, depending on the subject's cycle of infusions during prior IGIV treatment. Subjects were randomised to receive either 5 infusions of Gammaplex 5% followed by 5 infusions of Gammaplex 10%, or 5 infusions of Gammaplex 10% followed by 5 infusions of Gammaplex 5%.

    Arm title
    		 Gammaplex 10% on a 21 or 28 day treatment schedule
    Arm description
    		 Paediatric subjects aged <16 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gammaplex 10%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All subjects were to receive a dose of 300 to 800 mg/kg/infusion. Subjects were to receive the same dose as per their prior IGIV. Infusions were administered on either a 21-day or 28-day treatment schedule, depending on the subject's cycle of infusions during prior IGIV treatment.

    Number of subjects in period 1
    		Gammaplex 5% & Gammaplex 10% on a 21-day treatment schedule Gammaplex 5% & Gammaplex 10% on a 28-day treatment schedule Gammaplex 10% on a 21 or 28 day treatment schedule
    Started
    14
    19
    15
    Completed
    14
    18
    14
    Not completed
    0
    1
    1
         Consent withdrawn by subject
    -
    1
    -
         Physician decision
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gammaplex 5% & Gammaplex 10% on a 21-day treatment schedule
    Reporting group description
    		 Adult subjects aged 16+ years

    Reporting group title
    Gammaplex 5% & Gammaplex 10% on a 28-day treatment schedule
    Reporting group description
    		 Adult subjects aged 16+ years

    Reporting group title
    Gammaplex 10% on a 21 or 28 day treatment schedule
    Reporting group description
    		 Paediatric subjects aged <16 years

    Reporting group values
    		 Gammaplex 5% & Gammaplex 10% on a 21-day treatment schedule Gammaplex 5% & Gammaplex 10% on a 28-day treatment schedule Gammaplex 10% on a 21 or 28 day treatment schedule Total
    Number of subjects
    		 14 19 15 48
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 9 9
        Adolescents (12-17 years)
    		 1 1 6 8
        Adults (18-64 years)
    		 13 18 0 31
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 12 9 7 28
        Male
    		 2 10 8 20

    End points

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    End points reporting groups
    Reporting group title
    Gammaplex 5% & Gammaplex 10% on a 21-day treatment schedule
    Reporting group description
    		 Adult subjects aged 16+ years

    Reporting group title
    Gammaplex 5% & Gammaplex 10% on a 28-day treatment schedule
    Reporting group description
    		 Adult subjects aged 16+ years

    Reporting group title
    Gammaplex 10% on a 21 or 28 day treatment schedule
    Reporting group description
    		 Paediatric subjects aged <16 years

    Primary: Area under the curve within a 28-day dosing interval (absolute values)

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    End point title
    		 Area under the curve within a 28-day dosing interval (absolute values) [1] [2]
    End point description
    Absolute AUC(0-t)
    End point type
    Primary
    End point timeframe
    After a minimum of 5 infusions of Gammaplex 5% and a minimum of 5 infusions of Gammaplex 10%
    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 analysis was not performed. This secondary analysis comprised a bioequivalence assessment on the PK parameters.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The primary endpoint was based on the bioequivalence of Gammaplex 10% and Gammaplex 5% at the 28 day dosing interval only.
    End point values
    		 Gammaplex 5% & Gammaplex 10% on a 28-day treatment schedule
    Number of subjects analysed
    16
    Units: ratio Gammaplex 10%/Gammaplex 5%
        number (confidence interval 90%)
    1.01 (0.98 to 1.03)
    No statistical analyses for this end point

    Primary: Area under the curve within a 28-day dosing interval (baseline-adjusted values)

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    End point title
    		 Area under the curve within a 28-day dosing interval (baseline-adjusted values) [3] [4]
    End point description
    Baseline-adjusted AUC(0-t)
    End point type
    Primary
    End point timeframe
    After a minimum of 5 infusions of Gammaplex 5% and a minimum of 5 infusions of Gammaplex 10%
    Notes
    [3] - 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 analysis was not performed. The primary analysis comprised a bioequivalence assessment on the PK parameters.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The primary endpoint was based on the bioequivalence of Gammaplex 10% and Gammaplex 5% at the 28 day dosing interval only.
    End point values
    		 Gammaplex 5% & Gammaplex 10% on a 28-day treatment schedule
    Number of subjects analysed
    16
    Units: ratio Gammaplex 10%/Gammaplex 5%
        number (confidence interval 90%)
    1.07 (0.93 to 1.23)
    No statistical analyses for this end point

    Secondary: Area under the curve within a 21-day dosing interval (absolute values)

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    End point title
    		 Area under the curve within a 21-day dosing interval (absolute values) [5]
    End point description
    End point type
    Secondary
    End point timeframe
    After a minimum of 5 infusions of Gammaplex 5% and a minimum of 5 infusions of Gammaplex 10%
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This secondary endpoint was based on the bioequivalence of Gammaplex 10% and Gammaplex 5% at the 21 day dosing interval only.
    End point values
    		 Gammaplex 5% & Gammaplex 10% on a 21-day treatment schedule
    Number of subjects analysed
    14
    Units: ratio Gammaplex 10%/Gammaplex 5%
        number (confidence interval 90%)
    0.99 (0.95 to 1.02)
    No statistical analyses for this end point

    Secondary: Area under the curve within a 21-day dosing interval (baseline-adjusted values)

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    End point title
    		 Area under the curve within a 21-day dosing interval (baseline-adjusted values) [6]
    End point description
    End point type
    Secondary
    End point timeframe
    After a minimum of 5 infusions of Gammaplex 5% and a minimum of 5 infusions of Gammaplex 10%
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This secondary endpoint was based on the bioequivalence of Gammaplex 10% and Gammaplex 5% at the 21 day dosing interval only.
    End point values
    		 Gammaplex 5% & Gammaplex 10% on a 21-day treatment schedule
    Number of subjects analysed
    14
    Units: ratio
        number (confidence interval 90%)
    1.1 (0.96 to 1.26)
    No statistical analyses for this end point

    Secondary: IgG trough levels for 28-day dosing interval

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    End point title
    		 IgG trough levels for 28-day dosing interval [7]
    End point description
    End point type
    Secondary
    End point timeframe
    After a minimum of 5 infusions of Gammaplex 5% and a minimum of 5 infusions of Gammaplex 10%
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This secondary endpoint was based on the bioequivalence of Gammaplex 10% and Gammaplex 5% at the 28 day dosing interval only.
    End point values
    		 Gammaplex 5% & Gammaplex 10% on a 28-day treatment schedule
    Number of subjects analysed
    16
    Units: ratio Gammaplex 10%/Gammaplex 5%
        number (confidence interval 90%)
    0.98 (0.94 to 1.02)
    No statistical analyses for this end point

    Secondary: IgG trough levels for 21-day dosing interval

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    End point title
    		 IgG trough levels for 21-day dosing interval [8]
    End point description
    End point type
    Secondary
    End point timeframe
    After a minimum of 5 infusions of Gammaplex 5% and a minimum of 5 infusions of Gammaplex 10%
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This secondary endpoint was based on the bioequivalence of Gammaplex 10% and Gammaplex 5% at the 28 day dosing interval only.
    End point values
    		 Gammaplex 5% & Gammaplex 10% on a 21-day treatment schedule
    Number of subjects analysed
    14
    Units: ratio Gammaplex 10%/Gammaplex 5%
        number (confidence interval 90%)
    0.95 (0.92 to 0.99)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signature of informed consent until 28 days following the last dose of Gammaplex 5% or Gammaplex 10%
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Gammaplex 5% - all subjects
    Reporting group description
    		 -

    Reporting group title
    Gammaplex 10% - all subjects
    Reporting group description
    		 -

    Serious adverse events
    		 Gammaplex 5% - all subjects Gammaplex 10% - all subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 47 (2.13%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    neuroendocrine tumour
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    IIIrd nerve paralysis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Gammaplex 5% - all subjects Gammaplex 10% - all subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 33 (69.70%)
    44 / 47 (93.62%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 33 (18.18%)
    11 / 47 (23.40%)
         occurrences all number
    16
    28
    Migraine
         subjects affected / exposed
    3 / 33 (9.09%)
    3 / 47 (6.38%)
         occurrences all number
    4
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 33 (9.09%)
    1 / 47 (2.13%)
         occurrences all number
    7
    5
    Pyrexia
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 33 (6.06%)
    2 / 47 (4.26%)
         occurrences all number
    2
    2
    Nausea
         subjects affected / exposed
    3 / 33 (9.09%)
    1 / 47 (2.13%)
         occurrences all number
    3
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 33 (6.06%)
    4 / 47 (8.51%)
         occurrences all number
    2
    4
    Oropharyngeal pain
         subjects affected / exposed
    3 / 33 (9.09%)
    2 / 47 (4.26%)
         occurrences all number
    3
    2
    Rales
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 33 (0.00%)
    5 / 47 (10.64%)
         occurrences all number
    0
    6
    Dermatitis
         subjects affected / exposed
    3 / 33 (9.09%)
    1 / 47 (2.13%)
         occurrences all number
    3
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 33 (9.09%)
    0 / 47 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 47 (6.38%)
         occurrences all number
    2
    4
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 33 (6.06%)
    8 / 47 (17.02%)
         occurrences all number
    2
    8
    Nasopharyngitis
         subjects affected / exposed
    1 / 33 (3.03%)
    5 / 47 (10.64%)
         occurrences all number
    2
    7
    Viral upper respiratory tract infection
         subjects affected / exposed
    4 / 33 (12.12%)
    4 / 47 (8.51%)
         occurrences all number
    5
    5
    Acute sinusitis
         subjects affected / exposed
    5 / 33 (15.15%)
    3 / 47 (6.38%)
         occurrences all number
    6
    3
    Chronic sinusitis
         subjects affected / exposed
    2 / 33 (6.06%)
    4 / 47 (8.51%)
         occurrences all number
    2
    4
    Sinusitis
         subjects affected / exposed
    1 / 33 (3.03%)
    7 / 47 (14.89%)
         occurrences all number
    1
    7
    Influenza
         subjects affected / exposed
    0 / 33 (0.00%)
    6 / 47 (12.77%)
         occurrences all number
    0
    6
    Bronchitis
         subjects affected / exposed
    3 / 33 (9.09%)
    0 / 47 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 May 2014
    Investigational New Drug number added Abbreviations updated Exclusion criterion 18: clarified fructose intolerance Exclusion criteria 13 and 14: defined ‘chronic’ added recommended frequency of monitoring vital signs PK sample collection windows expanded to allow for subject compliance guidance provided for recording medical history defined who could record TEE monitoring added that results of a chest x-ray or CT scan could be used at Screening instead of only chest x-ray clarified dosing calculation formula removed reference to Table 6, Appendix I (Summary of Investigator and Sponsor Reporting Responsibilities) DMC first meeting date modified correction of DMC abbreviation Table 6 (Schedule of Study Visit Assessments): footnote d amended to include CT scan Table 7 (Schedule of Pharmacokinetic Assessments): PK sample collection windows expanded to allow for subject compliance
    09 Oct 2014
    Added text to allow for additional infusions if subjects have dosing/scheduling issues and are not at steady state prior to the scheduled PK sampling Added text to mention the role of the Home Health Agency in PK sampling Removed the requirement for the infusion bag to be made of polyvinyl chloride
    16 Jul 2015
    Added measles antibody testing to the list of specific antibody tests (to be performed on the last available reserve blood sample taken after each treatment period) Updated Sponsor contact details

    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/28316003
    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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