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    Clinical Trial Results:
    A Multicenter Study on the Efficacy and Safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)

    Summary
    EudraCT number
    		 2006-006522-25
    Trial protocol
    		 DE   GB   BE   GR   IT   ES  
    Global end of trial date
    31 Oct 2008

    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_005CR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00520494
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CSL Behring AG
    Sponsor organisation address
    Wankdorfstrasse 10, Berne 22, Switzerland, CH-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
    03 Mar 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to assess the efficacy and safety of Vivaglobin in PUPs with PID common variable immunodeficiency (CVID) or X-linked agammaglobulinemia (XLA), who were free of serious bacterial infections (SBIs) at initiation of therapy. The primary efficacy objective of this open-label study was to assess whether subcutaneous immunoglobulin (SCIG) treatment with a loading dose of Vivaglobin of 100 mg/kg bw for 5 consecutive days resulted in an immunoglobulin G (IgG) increase to ≥5 g/L as measured on Day 12 after initiation of SCIG therapy.
    Protection of trial subjects
    This study was carried out in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice guidelines, and standard operating procedures for clinical research and development at CSL Behring (CSLB). The study protocol and all amendments were approved by the Independent Ethics Committee(s) (IECs) / Institutional Review Board(s) (IRBs) of the participating centers. Before undergoing screening procedures for possible enrollment into the study, subjects were informed, in an understandable form, about the nature, scope, and possible consequences of the study. The investigator was responsible for obtaining a subject’s written informed consent to participate in the study. The investigator may cease study treatment and withdraw the subject, or the subject may withdraw himself from participation in the study at any time. If a subject is withdrawn from the study or further participation is declined, the subject will continue to have access to medical care and will be treated according to routine medical practice, but will no longer receive the investigational medicinal product (IMP).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 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
    Spain: 2
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Canada: 6
    Worldwide total number of subjects
    18
    EEA total number of subjects
    12
    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)
    6
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    8
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 6 sites in Canada, Germany, Italy, and Spain included a total of 18 patients screened and enrolled for this study.

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

    Arms
    Arm title
    		 Vivaglobin
    Arm description
    		 Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for subcutaneous (SC) use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Human normal immunoglobulin G (IgG) for subcutaneous (SC) use
    Investigational medicinal product code
    CE1200
    Other name
    Vivaglobin®
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosage form: Glycine-buffered pasteurized liquid containing 16% IgG for SC infusion

    Number of subjects in period 1
    		Vivaglobin
    Started
    18
    Completed
    17
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 18 18
    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)
    		 6 6
        Adolescents (12-17 years)
    		 2 2
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.9 ( 21.85 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    Vivaglobin
    Reporting group description
    		 Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for subcutaneous (SC) use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.

    Primary: Proportion of Subjects Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12

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    End point title
    		 Proportion of Subjects Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Day 12
    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: Primary end point data analysis consisted of the calculation of a proportion and a 2-sided 95% confidence interval as per protocol; no statistical hypothesis was planned or conducted.
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [2]
    Units: proportion of subjects
        number (confidence interval 95%)
    0.944 (0.7271 to 0.9986)
    Notes
    [2] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving IgG Levels ≥ 5 g/L on Day 19

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    End point title
    		 Proportion of Subjects Achieving IgG Levels ≥ 5 g/L on Day 19
    End point description
    End point type
    Secondary
    End point timeframe
    Day 19
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [3]
    Units: proportion of subjects
        number (confidence interval 95%)
    0.944 (0.7271 to 0.9986)
    Notes
    [3] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving IgG Levels ≥ 5 g/L on Day 26

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    End point title
    		 Proportion of Subjects Achieving IgG Levels ≥ 5 g/L on Day 26
    End point description
    End point type
    Secondary
    End point timeframe
    Day 26
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [4]
    Units: proportion of subjects
        number (confidence interval 95%)
    1 (0.8147 to 1)
    Notes
    [4] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: IgG Increase (Change From Baseline) on Day 12

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    End point title
    		 IgG Increase (Change From Baseline) on Day 12
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Day 12
    End point values
    		 Vivaglobin
    Number of subjects analysed
    17 [5]
    Units: g/L
        arithmetic mean (standard deviation)
    3.941 ( 0.7466 )
    Notes
    [5] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Overall Rate of Infections

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    End point title
    		 Overall Rate of Infections
    End point description
    Annualized rate of any infection. The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Infections were defined as all AEs with the system organ classification of "infections and infestations."
    End point type
    Secondary
    End point timeframe
    For the duration of the study, up to approximately 25 weeks
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [6]
    Units: infections per subject year
        number (confidence interval 95%)
    2.785 (1.785 to 4.144)
    Notes
    [6] - Intent-to-treat data set Number of infections analyzed: 24
    No statistical analyses for this end point

    Secondary: Total Serum IgG Trough Levels on Day 12

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    End point title
    		 Total Serum IgG Trough Levels on Day 12
    End point description
    End point type
    Secondary
    End point timeframe
    Day 12
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [7]
    Units: g/L
        arithmetic mean (standard deviation)
    7.466 ( 1.4592 )
    Notes
    [7] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Total Serum IgG Trough Levels at Week 25

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    End point title
    		 Total Serum IgG Trough Levels at Week 25
    End point description
    End point type
    Secondary
    End point timeframe
    Week 25
    End point values
    		 Vivaglobin
    Number of subjects analysed
    17 [8]
    Units: g/L
        arithmetic mean (standard deviation)
    8.039 ( 1.1793 )
    Notes
    [8] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12

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    End point title
    		 Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12
    End point description
    End point type
    Secondary
    End point timeframe
    Day 12
    End point values
    		 Vivaglobin
    Number of subjects analysed
    16 [9]
    Units: IU/mL
    arithmetic mean (standard deviation)
        Cytomegalovirus
    3.182 ( 0.8025 )
        Tetanus
    1.399 ( 0.3846 )
        Measles
    0.743 ( 0.3681 )
    Notes
    [9] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25

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    End point title
    		 Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25
    End point description
    End point type
    Secondary
    End point timeframe
    Week 25
    End point values
    		 Vivaglobin
    Number of subjects analysed
    15 [10]
    Units: IU/mL
    arithmetic mean (standard deviation)
        Cytomegalovirus
    3.638 ( 2.2649 )
        Tetanus
    1.623 ( 0.9344 )
        Measles
    0.879 ( 0.8993 )
    Notes
    [10] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12

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    End point title
    		 Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12
    End point description
    End point type
    Secondary
    End point timeframe
    Day 12
    End point values
    		 Vivaglobin
    Number of subjects analysed
    16 [11]
    Units: mg/L
    arithmetic mean (standard deviation)
        H. influenzae
    1.023 ( 0.3141 )
        S. pneumoniae
    18.588 ( 9.4659 )
    Notes
    [11] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25

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    End point title
    		 Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25
    End point description
    End point type
    Secondary
    End point timeframe
    Week 25
    End point values
    		 Vivaglobin
    Number of subjects analysed
    15 [12]
    Units: mg/L
    arithmetic mean (standard deviation)
        H. influenzae
    1.671 ( 0.7796 )
        S. pneumoniae
    26.985 ( 22.2594 )
    Notes
    [12] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Use of Antibiotics for Infection Prophylaxis and Treatment

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    End point title
    		 Use of Antibiotics for Infection Prophylaxis and Treatment
    End point description
    Number of subjects using antibiotics for infection prophylaxis and treatment. Medications were classified as antibiotics according to the anatomic therapeutic chemical code.
    End point type
    Secondary
    End point timeframe
    For the duration of the study, up to approximately 25 weeks
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [13]
    Units: subjects
        Prophylaxis
    1
        Treatment
    8
    Notes
    [13] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years)

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    End point title
    		 Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years)
    End point description
    The SF-36 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 study completion, approximately Week 25
    End point values
    		 Vivaglobin
    Number of subjects analysed
    10 [14]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Physical functioning
    75.5 ( 33.948 )
        Role-physical
    70.63 ( 37.038 )
        Bodily pain
    65.6 ( 37.262 )
        General health
    56.4 ( 27.097 )
        Vitality
    54.4 ( 28.575 )
        Social functioning
    80 ( 30.162 )
        Role-emotional
    79.17 ( 33.158 )
        Mental health
    74.5 ( 23.268 )
    Notes
    [14] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years)

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    End point title
    		 Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years)
    End point description
    The CHQ-PF50 is a 50-item questionnaire that measures generic health concepts and is suitable for patients younger than 14 years of age. The questions are grouped into 15 domains: global health, physical functioning, role/social limitations - emotional/behavioral, role/social limitations - physical, bodily pain, behavior, global behavior, mental health, self esteem, general health perceptions, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Scores range from 0 to 100, with higher scores indicating a better health state.
    End point type
    Secondary
    End point timeframe
    At study completion, approximately Week 25
    End point values
    		 Vivaglobin
    Number of subjects analysed
    8 [15]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Global health
    82.5 ( 15.353 )
        Physical functioning
    97.91 ( 4.135 )
        Role/social limitations - emotional/behavioral
    100 ( 0 )
        Role/social limitations - physical
    95.84 ( 11.773 )
        Bodily pain
    82.5 ( 24.349 )
        Behavior
    74.06 ( 13.899 )
        Global behavior
    75.63 ( 12.939 )
        Mental health
    83.13 ( 13.871 )
        Self esteem
    90.64 ( 6.948 )
        General health perceptions
    61.66 ( 22.791 )
        Change in health
    84.38 ( 18.601 )
        Parental impact - emotional
    64.58 ( 39.53 )
        Parental impact - time
    88.9 ( 15.698 )
        Family activities
    86.98 ( 17.457 )
        Family cohesion
    77.5 ( 15.353 )
    Notes
    [15] - Intent-to-treat data set
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs) by Severity and Relatedness

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    End point title
    		 Number of Subjects With Adverse Events (AEs) by Severity and Relatedness
    End point description
    Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
    End point type
    Secondary
    End point timeframe
    For the duration of the study, up to approximately 25 weeks
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [16]
    Units: subjects
        Total AEs
    14
        Mild AEs
    14
        Moderate AEs
    5
        Severe AEs
    2
        Not related AEs
    14
        Possibly related AEs
    3
        Probably related AEs
    4
        Related AEs
    5
    Notes
    [16] - Safety data set
    No statistical analyses for this end point

    Secondary: Rate of AEs by Severity and Relatedness

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    End point title
    		 Rate of AEs by Severity and Relatedness
    End point description
    The rate was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
    End point type
    Secondary
    End point timeframe
    For the duration of the study, up to approximately 25 weeks
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [17]
    Units: AEs per infusion
    number (not applicable)
        Total AEs
    0.305
        Mild AEs
    0.263
        Moderate AEs
    0.034
        Severe AEs
    0.007
        Not related AEs
    0.2
        Possibly related AEs
    0.013
        Probably related AEs
    0.018
        Related AEs
    0.074
    Notes
    [17] - Safety data set Number of infusions analyzed: 551
    No statistical analyses for this end point

    Secondary: Number of Subjects With Local Reactions by Severity and Relatedness

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    End point title
    		 Number of Subjects With Local Reactions by Severity and Relatedness
    End point description
    Local reactions included: infusion site erythema, infusion site pain, infusion site pruritus, infusion site rash, infusion site reaction, infusion site swelling, injection site bruising, injection site erythema, injection site irritation, injection site pruritus, injection site swelling, edema peripheral, tenderness, erythema, pruritus, and skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
    End point type
    Secondary
    End point timeframe
    For the duration of the study, up to approximately 25 weeks
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [18]
    Units: participants
        Total local reactions
    6
        Mild local reactions
    6
        Moderate local reactions
    0
        Severe local reactions
    0
        Not related local reactions
    1
        Possibly related local reactions
    0
        Probably related local reactions
    1
        Related local reactions
    5
    Notes
    [18] - Safety data set
    No statistical analyses for this end point

    Secondary: Rate of Local Reactions by Severity and Relatedness

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    End point title
    		 Rate of Local Reactions by Severity and Relatedness
    End point description
    The rate was the number of local reactions over the number of infusions administered. Local reactions included: infusion site: erythema, pain, pruritus, rash, reaction, swelling; injection site: bruising, erythema, irritation, pruritus, swelling; edema peripheral; tenderness; erythema; pruritus; and skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
    End point type
    Secondary
    End point timeframe
    For the duration of the study, up to approximately 25 weeks
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [19]
    Units: local reactions per infusion
    number (not applicable)
        Total local reactions
    0.076
        Mild local reactions
    0.076
        Moderate local reactions
    0
        Severe local reactions
    0
        Not related local reactions
    0.004
        Possibly related local reactions
    0.004
        Probably related local reactions
    0.009
        Related local reactions
    0.064
    Notes
    [19] - Safety data set Number of infusions analyzed: 551
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Relevant Changes in Routine Laboratory Parameters

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    End point title
    		 Number of Subjects With Clinically Relevant Changes in Routine Laboratory Parameters
    End point description
    Laboratory parameters included hematology, serum chemistry, and urinalysis parameters, and were assessed at screening, Week 12 (hematology and serum chemistry) and at the completion visit (approximately Week 25).
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 25
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [20]
    Units: participants
    0
    Notes
    [20] - Safety data set
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Relevant Changes in Vital Signs

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    End point title
    		 Number of Subjects With Clinically Relevant Changes in Vital Signs
    End point description
    Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
    End point type
    Secondary
    End point timeframe
    At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25)
    End point values
    		 Vivaglobin
    Number of subjects analysed
    18 [21]
    Units: participants
    0
    Notes
    [21] - Safety data set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For the duration of the study, up to approximately 25 weeks.
    Adverse event reporting additional description
    Safety data set: all treated subjects.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Vivaglobin
    Reporting group description
    		 Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.

    Serious adverse events
    		 Vivaglobin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 18 (11.11%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 18 (5.56%)
         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 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Meningitis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pseudomonas bronchitis
         subjects affected / exposed
    1 / 18 (5.56%)
         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
    		 Vivaglobin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 18 (77.78%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Infusion site erythema
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    7
    Infusion site pain
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    4
    Injection site bruising
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Injection site erythema
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    5
    Injection site pruritus
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Injection site swelling
         subjects affected / exposed
    4 / 18 (22.22%)
         occurrences all number
    9
    Oedema peripheral
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Pyrexia
         subjects affected / exposed
    5 / 18 (27.78%)
         occurrences all number
    11
    Chills
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Feeling hot
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Infusion site pruritus
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Infusion site rash
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Infusion site reaction
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Infusion site swelling
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    3
    Injection site irritation
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Tenderness
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    4
    Dysphonia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    3
    Nasal congestion
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Nasal discomfort
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Pharyngeal oedema
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Pharyngolaryngeal pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Throat tightness
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Nervousness
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 18 (27.78%)
         occurrences all number
    13
    Disturbance in attention
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Migraine
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Haemolysis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Eye disorders
    Eye swelling
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 18 (22.22%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Abdominal distension
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Cheilitis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Enteritis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Oral pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Stomach discomfort
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Swollen tongue
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Pruritus
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Urticaria
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Dermatitis allergic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Pruritus generalised
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Rosacea
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Skin swelling
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Renal pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    5
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    4
    Candidiasis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    3
    Otitis media
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jan 2008
    This amendment specified the sample size in more detail, defined further secondary efficacy endpoints, specified the per protocol efficacy data set in more detail, and updated the number of study sites and location. Further editorial changes to reflect recent change in sponsor name and staff, reporting of SAEs and shipment of samples were incorporated.

    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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