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    Clinical Trial Results:
    A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency

    Summary
    EudraCT number
    2006-006745-13
    Trial protocol
    DE   GB   FR   ES   SE   IT   PL  
    Global end of trial date
    31 Aug 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ZLB06_001CR
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00542997
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    CSL Behring AG
    Sponsor organisation address
    Wankdorfstrasse 10, Bern 22, Switzerland, 3000
    Public contact
    Trial Registration Co-ordinator, CSL Behring, clinicaltrials@cslbehring.com
    Scientific contact
    Trial Registration Co-ordinator, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Oct 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy, tolerability, safety, and pharmacokinetics (PK) of IgPro20 in subjects with primary immunodeficiency (PID). As the primary objective, the IgPro20 dose should result in sustained immunoglobulin G (IgG) trough levels (Ctrough) comparable to the previous IgG treatment.
    Protection of trial subjects
    This study was conducted in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and standard operating procedures for clinical research and development at CSL Behring and the Clinical Research Organisations (CROs) involved. Compliance with these requirements also constitutes conformity with the ethical principles of the Declaration of Helsinki (version of 1996). The study was conducted under a protocol reviewed and approved by an IEC/IRB; the study was conducted by scientifically and medically qualified persons; the benefits of the study were in proportion to the risks; the rights and welfare of the subjects were respected; the physicians conducting the study did not find the hazards to outweigh the potential benefits; the results reported are accurate; and each subject or subject’s parent or legal guardian gave his or her written informed consent before any protocol driven tests or evaluations were performed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Sep 2007
    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
    Romania: 10
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 14
    Worldwide total number of subjects
    51
    EEA total number of subjects
    49
    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)
    18
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    26
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This multinational study enrolled subjects at 15 of the participating study centers in Europe.

    Pre-assignment
    Screening details
    Screening took place 1 to 4 weeks prior to the first IgPro20 infusion.

    Period 1
    Period 1 title
    Wash in / Wash out Period
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    IgPro20
    Arm description
    IgPro20 administered as a subcutaneous infusion at weekly intervals by the subject/parent/guardian.
    Arm type
    Experimental

    Investigational medicinal product name
    IgPro20
    Investigational medicinal product code
    Other name
    Human Normal Immunoglobulin for Subcutaneous Administration (IGSC), Hizentra, SCIG
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.

    Number of subjects in period 1
    IgPro20
    Started
    51
    Completed
    46
    Not completed
    5
         Adverse event, non-fatal
             3
         Consent withdrawn by subject
             2
    Period 2
    Period 2 title
    Efficacy Period
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    IgPro20
    Arm description
    IgPro20 administered as a subcutaneous infusion at weekly intervals by the subject/parent/guardian.
    Arm type
    Experimental

    Investigational medicinal product name
    IgPro20
    Investigational medicinal product code
    Other name
    Human Normal Immunoglobulin for Subcutaneous Administration (IGSC), Hizentra, SCIG
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.

    Number of subjects in period 2
    IgPro20
    Started
    46
    Completed
    43
    Not completed
    3
         Adverse event, non-fatal
             3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IgPro20
    Reporting group description
    IgPro20 administered as a subcutaneous infusion at weekly intervals by the subject/parent/guardian.

    Reporting group values
    IgPro20 Total
    Number of subjects
    51 51
    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)
    18 18
        Adolescents (12-17 years)
    7 7
        Adults (18-64 years)
    26 26
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    22.6 ± 16.02 -
    Gender categorical
    Units: Subjects
        Female
    16 16
        Male
    35 35
    Race
    Units: Subjects
        White
    51 51
    Type of Primary Immunodeficiency
    Units: Subjects
        Common variable immunodeficiency (CVID)
    30 30
        X-linked agammaglobulinemia (XLA)
    20 20
        Autosomal recessive agammaglobulinemia (ARAG)
    1 1

    End points

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    End points reporting groups
    Reporting group title
    IgPro20
    Reporting group description
    IgPro20 administered as a subcutaneous infusion at weekly intervals by the subject/parent/guardian.
    Reporting group title
    IgPro20
    Reporting group description
    IgPro20 administered as a subcutaneous infusion at weekly intervals by the subject/parent/guardian.

    Subject analysis set title
    IgPro20 (PK Substudy)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study.

    Primary: Total Serum IgG Trough Levels

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    End point title
    Total Serum IgG Trough Levels [1]
    End point description
    Total IgG trough levels for IgPro20 treatment at steady state were compared with documented trough level data for IgG treatment received prior to enrolling in the study (pre-study data are from enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment). For this purpose, 6 consecutive IgPro20 trough values (obtained prior to infusions 12 to 17) per subject were aggregated to the subject’s median value and then median values across subjects were summarised using descriptive statistics. The same procedure was applied to pre-study treatment using the 3 most recent IgG trough values ≥ 5 g/L obtained prior to the first IgPro20 infusion. The intention-to-treat (ITT) population included all subjects treated with IgPro20 during the efficacy period (starting with Week 12); pre-study treatment IgG trough levels were not available for 2 subjects.
    End point type
    Primary
    End point timeframe
    Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (Infusions 12 to 17)
    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: Variables were summarized using descriptive statistics.
    End point values
    IgPro20
    Number of subjects analysed
    46 [2]
    Units: g/L
    arithmetic mean (standard deviation)
        Pre-study, n = 44
    7.49 ± 1.57
        Infusions 12 to 17, n = 46
    8.1 ± 1.44
    Notes
    [2] - Intention-to-treat (ITT) population.
    No statistical analyses for this end point

    Secondary: Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)

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    End point title
    Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)
    End point description
    Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters. The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days. Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).
    End point type
    Secondary
    End point timeframe
    Efficacy period: week 12 to week 40 after study start or to the completion visit
    End point values
    IgPro20
    Number of subjects analysed
    46 [3]
    Units: SBIs/subject/year
    0
    Notes
    [3] - ITT population. Number of Subject Days Analyzed: 8745
    No statistical analyses for this end point

    Secondary: Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population)

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    End point title
    Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population)
    End point description
    Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters. The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the PPE population and adjusted to 365 days. Per Protocol Efficacy (PPE) population analysis. The PPE population included all subjects who completed the 28-week efficacy period according to protocol.
    End point type
    Secondary
    End point timeframe
    Efficacy period: week 12 to week 40 after study start or to the completion visit
    End point values
    IgPro20
    Number of subjects analysed
    34 [4]
    Units: SBIs/subject/year
    0
    Notes
    [4] - PPE population Number of Subject Days Analyzed: 6729
    No statistical analyses for this end point

    Secondary: Annual Rate of Infection Episodes

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    End point title
    Annual Rate of Infection Episodes
    End point description
    The annual rate of episodes was calculated based on the total number of any infection type and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days. Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).
    End point type
    Secondary
    End point timeframe
    Efficacy period: week 12 to week 40 after study start or to the completion visit
    End point values
    IgPro20
    Number of subjects analysed
    46 [5]
    Units: episodes/subject/year
        number (confidence interval 95%)
    5.18 (4.31 to 6.17)
    Notes
    [5] - ITT population Number of Subject Days Analyzed: 8745
    No statistical analyses for this end point

    Secondary: Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections

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    End point title
    Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections
    End point description
    The annual rate was calculated based on the total number of days out of work/school/kindergarten/day care or unable to perform normal activities due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days. Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).
    End point type
    Secondary
    End point timeframe
    Efficacy period: week 12 to week 40 after study start or to the completion visit
    End point values
    IgPro20
    Number of subjects analysed
    46 [6]
    Units: days/subject/year
        number (not applicable)
    8
    Notes
    [6] - ITT population Number of Subject Days Analyzed: 9033
    No statistical analyses for this end point

    Secondary: Annual Rate of the Number of Days of Hospitalization Due to Infections

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    End point title
    Annual Rate of the Number of Days of Hospitalization Due to Infections
    End point description
    The annual rate was calculated based on the total number of days of hospitalization due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days. Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).
    End point type
    Secondary
    End point timeframe
    Efficacy period: week 12 to week 40 after study start or to the completion visit
    End point values
    IgPro20
    Number of subjects analysed
    46 [7]
    Units: days/subject/year
        number (not applicable)
    3.48
    Notes
    [7] - ITT population Number of Subject Days Analyzed: 9033
    No statistical analyses for this end point

    Secondary: Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment

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    End point title
    Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment
    End point description
    The annual rate was calculated based on the total number of days of antibiotic use in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days. Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).
    End point type
    Secondary
    End point timeframe
    Efficacy period: week 12 to week 40 after study start or to the completion visit
    End point values
    IgPro20
    Number of subjects analysed
    46 [8]
    Units: days/subject/year
        number (not applicable)
    72.75
    Notes
    [8] - ITT population Number of Subject Days Analyzed: 8745
    No statistical analyses for this end point

    Other pre-specified: Maximum Concentration (Cmax) of Total Serum IgG

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    End point title
    Maximum Concentration (Cmax) of Total Serum IgG
    End point description
    Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.
    End point type
    Other pre-specified
    End point timeframe
    Week 28 (±1week)
    End point values
    IgPro20 (PK Substudy)
    Number of subjects analysed
    23
    Units: g/L
        arithmetic mean (standard deviation)
    8.26 ± 1.25
    No statistical analyses for this end point

    Other pre-specified: Timepoint of Maximum Concentration (Tmax) of Total Serum IgG

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    End point title
    Timepoint of Maximum Concentration (Tmax) of Total Serum IgG
    End point description
    Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.
    End point type
    Other pre-specified
    End point timeframe
    Week 28 (±1week)
    End point values
    IgPro20 (PK Substudy)
    Number of subjects analysed
    23
    Units: day
        median (full range (min-max))
    2.06 (0.94 to 6.92)
    No statistical analyses for this end point

    Other pre-specified: Area Under the Concentration-Time Curve (AUC_last) of Total Serum IgG

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    End point title
    Area Under the Concentration-Time Curve (AUC_last) of Total Serum IgG
    End point description
    AUC_last = Area under the concentration-time curve until last measured concentration. Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.
    End point type
    Other pre-specified
    End point timeframe
    Week 28 (±1week)
    End point values
    IgPro20 (PK Substudy)
    Number of subjects analysed
    23
    Units: day*g/L
        arithmetic mean (standard deviation)
    53.7 ± 9.16
    No statistical analyses for this end point

    Other pre-specified: Area Under the Concentration-Time Curve (AUCτ) of Total Serum IgG

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    End point title
    Area Under the Concentration-Time Curve (AUCτ) of Total Serum IgG
    End point description
    AUCτ = Area under the concentration-time curve during regular dosing interval. Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population. 7 subjects were missing data for AUCτ.
    End point type
    Other pre-specified
    End point timeframe
    Week 28 (±1week)
    End point values
    IgPro20 (PK Substudy)
    Number of subjects analysed
    16 [9]
    Units: day*g/L
        arithmetic mean (standard deviation)
    53.61 ± 9.98
    Notes
    [9] - 7 subjects were missing data for AUCτ.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to approximately 40 weeks) or extended when serious adverse events were reported.
    Adverse event reporting additional description
    A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    IgPro20 (All Treated)
    Reporting group description
    All subjects receiving at least 1 infusion of IgPro20

    Serious adverse events
    IgPro20 (All Treated)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 51 (9.80%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    IgPro20 (All Treated)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 51 (90.20%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    13 / 51 (25.49%)
         occurrences all number
    26
    Oropharyngeal pain
         subjects affected / exposed
    4 / 51 (7.84%)
         occurrences all number
    12
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 51 (25.49%)
         occurrences all number
    54
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    6
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    13 / 51 (25.49%)
         occurrences all number
    13
    Injection site reaction
         subjects affected / exposed
    9 / 51 (17.65%)
         occurrences all number
    16
    Injection site pain
         subjects affected / exposed
    6 / 51 (11.76%)
         occurrences all number
    8
    Infusion site pain
         subjects affected / exposed
    5 / 51 (9.80%)
         occurrences all number
    10
    Injection site pruritus
         subjects affected / exposed
    5 / 51 (9.80%)
         occurrences all number
    17
    Injection site swelling
         subjects affected / exposed
    4 / 51 (7.84%)
         occurrences all number
    6
    Fatigue
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    6
    Infusion site haematoma
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    3
    Injection site erythema
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 51 (17.65%)
         occurrences all number
    15
    Vomiting
         subjects affected / exposed
    4 / 51 (7.84%)
         occurrences all number
    5
    Abdominal pain upper
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    4
    Nausea
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 51 (9.80%)
         occurrences all number
    5
    Pruritus
         subjects affected / exposed
    4 / 51 (7.84%)
         occurrences all number
    14
    Erythema
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    3
    Arthritis
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    16 / 51 (31.37%)
         occurrences all number
    26
    Nasopharyngitis
         subjects affected / exposed
    12 / 51 (23.53%)
         occurrences all number
    20
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 51 (23.53%)
         occurrences all number
    17
    Sinusitis
         subjects affected / exposed
    7 / 51 (13.73%)
         occurrences all number
    11
    Respiratory tract infection
         subjects affected / exposed
    4 / 51 (7.84%)
         occurrences all number
    5
    Acute sinusitis
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    4
    Gastroenteritis
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    3
    Oral herpes
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    3 / 51 (5.88%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 May 2007
    A lower limit haemoglobin value of 10 g/dL was defined; subjects with haemoglobin values < 10 g/dL throughout the study were to be discontinued. The secondary objective of changes in viral safety markers was deleted because viral safety markers were only measured at screening. The inclusion criteria were changed to allow subjects with a diagnosis of ARAG to enter the study and minor changes to the schedule of assessments were incorporated. Furthermore, an additional HRQL instrument, the TSQM, was incorporated. This amendment was implemented before any subjects had received the first infusion of IgPro20.
    31 May 2007
    The lower age limit of subjects participating in the study was raised to 16 years of age for study sites in the UK to fulfil the requirement of the South West Research Ethics Committee. This amendment was implemented before any subjects had received the first infusion of IgPro20.
    30 Jan 2009
    Based on slow recruitment and to ensure sufficient data for children, the number of study sites was changed from approximately 12 study sites to 21 study sites in Europe, the number of subjects was changed from approximately 36 enrolled subjects to 51 enrolled subjects, and the recruitment period was extended from approximately 4 months to 15 months. The number of subgroup analyses as well as the lowest number of subjects in a subgroup was limited to provide meaningful results. Subgroup analyses were only to be done for the primary endpoint and the secondary endpoints number of infections and number of days out of work/school/kindergarten/day care or unable to perform normal activities due to infections. An additional subgroup analysis of treatment-emergent AEs was stipulated. This amendment was implemented after all subjects had received the first infusion of IgPro20 and after 38 subjects had completed the study or had discontinued from the study.

    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/21705277
    http://www.ncbi.nlm.nih.gov/pubmed/21674136
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