Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43844   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

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

    Summary
    EudraCT number
    		 2008-000830-30
    Trial protocol
    		 DE   ES   FR   SE   GB  
    Global end of trial date
    21 Dec 2011

    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

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ZLB07_002CR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00751621
    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
    10 Apr 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.
    Protection of trial subjects
    This study was carried out in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki (version of 1996), and standard operating procedures for clinical research and development at CSL Behring and the Clinical Research Organizations involved. 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
    13 Aug 2008
    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
    Poland: 7
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Romania: 10
    Worldwide total number of subjects
    40
    EEA total number of subjects
    39
    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)
    15
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    18
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects who had previously participated in the pivotal study ZLB06_001CR (NCT00542997) were enrolled in the extension study ZLB07_002CR.

    Pre-assignment
    Screening details
    		 The number of subjects and sites was dependent on the subjects’ and sites’ interest to continue the IgPro20 treatment following the pivotal study ZLB06_001CR.

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

    Arms
    Arm title
    		 IgPro20
    Arm description
    		 Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IgPro20
    Investigational medicinal product code
    Other name
    IgG with Proline (IgPro), Hizentra
    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. Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR.

    Number of subjects in period 1
    		IgPro20
    Started
    40
    Completed
    36
    Not completed
    4
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    1
         Subject moved to another country
    1
         Poor adherence to asthma treatment
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    IgPro20
    Reporting group description
    		 Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR.

    Reporting group values
    		 IgPro20 Total
    Number of subjects
    		 40 40
    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)
    		 15 15
        Adolescents (12-17 years)
    		 7 7
        Adults (18-64 years)
    		 18 18
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 21.6 ± 15.31 -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 28 28

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    IgPro20
    Reporting group description
    		 Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR.

    Subject analysis set title
    HRQL - At Baseline
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Baseline values for those subjects in the Full-Analysis health related quality of life (HRQL) data set (defined as all subjects entered into the study who complete a baseline and at least 1 follow-up HRQL assessment), who were at least 15 years of age.

    Subject analysis set title
    HRQL - At End of Study
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    End of study values for subjects in the Full-Analysis HRQL data set (defined as all subjects entered into the study who complete a baseline and at least 1 follow-up HRQL assessment), who were at least 15 years of age.

    Primary: Total Serum IgG Trough Levels

    		 Close Top of page
    End point title
    		 Total Serum IgG Trough Levels [1]
    End point description
    The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics. The full analysis/intent to treat (ITT) dataset comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
    End point type
    Primary
    End point timeframe
    Up to 42 months
    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
    40 [2]
    Units: g/L
        arithmetic mean (standard deviation)
    7.97 ± 1.171
    Notes
    [2] - ITT population
    No statistical analyses for this end point

    Secondary: Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)

    		 Close Top of page
    End point title
    		 Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)
    End point description
    The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by the Medical Monitor and Investigator to determine if the event fulfilled the predefined criteria for SBIs. The full analysis/ITT dataset comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
    End point type
    Secondary
    End point timeframe
    Up to 42 months
    End point values
    		 IgPro20
    Number of subjects analysed
    40 [3]
    Units: SBIs per subject year
        number (not applicable)
    0.048
    Notes
    [3] - Number of subject study days analyzed: 38208
    No statistical analyses for this end point

    Secondary: Annualized Rate of Infection Episodes

    		 Close Top of page
    End point title
    		 Annualized Rate of Infection Episodes
    End point description
    The annualized rate was based on the total number of infection episodes occurring during the study divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. The full analysis/ITT dataset comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
    End point type
    Secondary
    End point timeframe
    Up to 42 months
    End point values
    		 IgPro20
    Number of subjects analysed
    40 [4]
    Units: infection episodes per subject year
        number (confidence interval 95%)
    3.334 (2.993 to 3.703)
    Notes
    [4] - ITT population. Number of Subject Study Days Analyzed: 38208
    No statistical analyses for this end point

    Secondary: Number of Infection Episodes

    		 Close Top of page
    End point title
    		 Number of Infection Episodes
    End point description
    Total number of infections for the ITT population. The full analysis/ITT dataset comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
    End point type
    Secondary
    End point timeframe
    Up to 42 months
    End point values
    		 IgPro20
    Number of subjects analysed
    40 [5]
    Units: infection episodes
    349
    Notes
    [5] - ITT population
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections
    End point description
    The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject diary days for all subjects in the ITT population and adjusted to 365 days. The full analysis/ITT dataset comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
    End point type
    Secondary
    End point timeframe
    Up to 42 months
    End point values
    		 IgPro20
    Number of subjects analysed
    40 [6]
    Units: days per subject year
        number (not applicable)
    6.773
    Notes
    [6] - ITT population Number of Subject Diary Days Analyzed: 38045
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections
    End point description
    Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections. The full analysis/ITT dataset comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
    End point type
    Secondary
    End point timeframe
    Up to 42 months
    End point values
    		 IgPro20
    Number of subjects analysed
    40 [7]
    Units: days
    706
    Notes
    [7] - ITT population
    No statistical analyses for this end point

    Secondary: Annualized Rate of Hospitalization Due to Infections

    		 Close Top of page
    End point title
    		 Annualized Rate of Hospitalization Due to Infections
    End point description
    The annualized rate was based on the total number of days of hospitalization due to infections and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days. The full analysis/ITT dataset comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
    End point type
    Secondary
    End point timeframe
    up to 42 months
    End point values
    		 IgPro20
    Number of subjects analysed
    40 [8]
    Units: days per subject year
        number (not applicable)
    1.055
    Notes
    [8] - ITT population. Number of Subject Diary Days Analyzed: 38045
    No statistical analyses for this end point

    Secondary: Number of Days of Hospitalization Due to Infections

    		 Close Top of page
    End point title
    		 Number of Days of Hospitalization Due to Infections
    End point description
    Total number of days of hospitalization due to infections for the ITT population. The full analysis/ITT dataset comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
    End point type
    Secondary
    End point timeframe
    Up to 42 months
    End point values
    		 IgPro20
    Number of subjects analysed
    40 [9]
    Units: days
    110
    Notes
    [9] - ITT population
    No statistical analyses for this end point

    Secondary: Use of Antibiotics for Infection Prophylaxis and Treatment

    		 Close Top of page
    End point title
    		 Use of Antibiotics for Infection Prophylaxis and Treatment
    End point description
    Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the ITT population, and adjusted to 365 days. The full analysis/ITT dataset comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
    End point type
    Secondary
    End point timeframe
    up to 42 months
    End point values
    		 IgPro20
    Number of subjects analysed
    40 [10]
    Units: days per subject year
        number (not applicable)
    72.13
    Notes
    [10] - ITT population Number of Subject Study Days Analyzed: 38208
    No statistical analyses for this end point

    Secondary: Health Related Quality of Life (Short Form 36 Health Survey)

    		 Close Top of page
    End point title
    		 Health Related Quality of Life (Short Form 36 Health Survey)
    End point description
    The Short Form 36 Health Survey is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.
    End point type
    Secondary
    End point timeframe
    At baseline and at the last available post-baseline observation for each subject (up to 42 months)
    End point values
    		 HRQL - At Baseline HRQL - At End of Study
    Number of subjects analysed
    20
    20
    Units: units on a scale
    median (full range (min-max))
        Physical Functioning
    95 (75 to 100)
    100 (20 to 100)
        Role-physical
    100 (18.8 to 100)
    100 (37.5 to 100)
        Role-emotional
    100 (25 to 100)
    100 (25 to 100)
        Social Functioning
    100 (62.5 to 100)
    100 (37.5 to 100)
        Bodily Pain
    84 (22 to 100)
    84 (22 to 100)
        Mental Health
    85 (55 to 95)
    80 (35 to 95)
        Vitality
    65.6 (31.3 to 81.3)
    75 (18.8 to 100)
        General Health
    52 (15 to 82)
    54.5 (20 to 92)
    No statistical analyses for this end point

    Secondary: Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit

    		 Close Top of page
    End point title
    		 Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit
    End point description
    The total number of subjects with clinically relevant changes in vital signs from baseline to the completion visit. Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature. The 'All Treated' (AT) safety data set included all subjects treated with study drug.
    End point type
    Secondary
    End point timeframe
    At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months)
    End point values
    		 IgPro20
    Number of subjects analysed
    39 [11]
    Units: participants
    0
    Notes
    [11] - AT population, reporting subjects with data collected at both baseline and completion
    No statistical analyses for this end point

    Secondary: Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit

    		 Close Top of page
    End point title
    		 Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit
    End point description
    The total number of subjects with clinically significant abnormal changes in routine laboratory parameters between baseline and the completion visit. Routine laboratory parameters included haematology, serum chemistry and urinalysis. The AT safety data set included all subjects treated with study drug.
    End point type
    Secondary
    End point timeframe
    At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months)
    End point values
    		 IgPro20
    Number of subjects analysed
    40 [12]
    Units: participants
        Haematology
    3
        Serum Chemistry
    1
        Urinalysis
    0
    Notes
    [12] - AT population, reporting subjects with data collected at both baseline and completion
    No statistical analyses for this end point

    Secondary: Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion

    		 Close Top of page
    End point title
    		 Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion
    End point description
    The rate of AEs was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. The AT safety data set included all subjects treated with study drug.
    End point type
    Secondary
    End point timeframe
    Up to 42 months
    End point values
    		 IgPro20
    Number of subjects analysed
    40 [13]
    Units: AEs per infusion
    number (not applicable)
        Total AEs
    0.0936
        Mild AEs
    0.0685
        Moderate AEs
    0.0231
        Severe AEs
    0.002
        At least possibly related AEs
    0.0026
        Serious AEs
    0.0033
        At least possibly related and serious AEs
    0
    Notes
    [13] - AT population. Number of Infusions Analyzed: 5405
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected for the duration of the study, up to 42 months.
    Adverse event reporting additional description
    A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    IgPro20
    Reporting group description
    		 Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR.

    Serious adverse events
    		 IgPro20
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 40 (35.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal column injury
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fracture
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenic purpura
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Agranulocytosis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Face oedema
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coeliac disease
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    Pneumonia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 40 (2.50%)
         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
    		 IgPro20
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 40 (97.50%)
    Investigations
    Weight increased
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    5
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Ligament sprain
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Surgical and medical procedures
    Wisdom teeth removal
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    6
    Sciatica
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    6
    Chest pain
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    5
    Abdominal pain upper
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    9
    Aphthous stomatitis
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Gastritis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 40 (27.50%)
         occurrences all number
    34
    Bronchiectasis
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    4
    Productive cough
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    4
    Rhinorrhoea
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Skin lesion
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Urticaria
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    7
    Back pain
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    21 / 40 (52.50%)
         occurrences all number
    51
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 40 (45.00%)
         occurrences all number
    49
    Sinusitis
         subjects affected / exposed
    13 / 40 (32.50%)
         occurrences all number
    31
    Nasopharyngitis
         subjects affected / exposed
    12 / 40 (30.00%)
         occurrences all number
    19
    Rhinitis
         subjects affected / exposed
    9 / 40 (22.50%)
         occurrences all number
    15
    Febrile infection
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    10
    Acute sinusitis
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    5
    Pharyngitis
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    10
    Influenza
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Viral infection
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Viral upper respiratory tract infection
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    5
    Conjunctivitis infective
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    11
    Ear infection
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    6
    Enteritis infectious
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    12
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    6
    Oral herpes
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    8
    Otitis media
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    8
    Pneumonia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Urinary tract infection
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    6
    Acute tonsillitis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Diarrhoea infectious
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Enterobiasis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Gastroenteritis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Laryngitis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    6
    Otitis externa
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Otitis media acute
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jan 2009
    This protocol amendment included the change of the supervising investigator for Germany (Leiter der klinischen Prüfung according to German drug law) and the biometrics service provider as well as several minor editorial changes.
    13 Jan 2009
    This was a country-specific amendment applicable for study sites in the UK. To fulfill the requirements of the MHRA, the study duration was defined as exactly 30 months.
    13 Jan 2009
    This was a country-specific amendment applicable for study sites in Sweden. To fulfill the requirements of the Swedish Competent Authorities (Läkemedelsverket), the study duration was defined as exactly 30 months. Additionally, the investigators were advised to contact subjects by telephone between the 6 monthly visits.
    06 Jul 2009
    This amendment included an increase in the maximum storage temperature of IgPro20, a switch from 50 mL IgPro20 bottles to 20 mL bottles, and a clarification concerning calculation of the visit intervals.
    06 Dec 2010
    This was a country-specific amendment applicable for all study sites, except the UK. The individual study duration depended on the time between last infusion within study ZLB06_001CR and the availability of IgPro20 on the European market, and could vary from country to country. The study duration was originally expected to not exceed 30 months, but was defined as not exceeding 42 months by this amendment.
    14 Mar 2011
    This was a country-specific amendment applicable for study sites in the UK. Study duration was previously defined as exactly 30 months in Substantial Amendment 3.0 and was prolonged to 36 months in this protocol amendment to satisfy MHRA request of better defining the study duration.

    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/24412910
    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.

    European Medicines Agency © 1995-Thu Apr 18 09:49:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA