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    Clinical Trial Results:
    Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID)

    Summary
    EudraCT number
    2007-002611-27
    Trial protocol
    DE   FR   GB  
    Global end of trial date
    30 Sep 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    31 Dec 2016
    First version publication date
    31 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GAM10-03
    Additional study identifiers
    ISRCTN number
    ISRCTN63491981
    US NCT number
    NCT00811174
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Octapharma AG
    Sponsor organisation address
    Seidenstrasse 2, Lachen, Switzerland, CH-8853
    Public contact
    Clinical Research Department, Octapharma Pharmazeutika Prod.Ges.m.b.H. , 0043 (1)61032-0,
    Scientific contact
    Clinical Research Department, Octapharma Pharmazeutika Prod.Ges.m.b.H. , 0043 (1)61032-0,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Sep 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2010
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to investigate the safety of Octagam® 10% in replacement therapy in PID and to compare the pharmacokinetic profile of Octagam® 10%with that of the previously used commercial Octagam® 5% (Pharmacokinetic sub-study). Safety outcome parameters will be: • Occurrence of adverse events. • Short term tolerance parameters including vital signs (blood pressure, heart rate, temperature, respiratory rate). • Laboratory parameters (hematology, clinical chemistry, direct Coombs’test, urinalysis) and tests for viral safety. Pharmacokinetic outcome parameters will be the parameter Cmax, Cmin, t ½, Tmax, AUC, volume of distribution, and incremental recovery of serum total IgG; of IgG subclasses (IgG1, IgG2, IgG3, IgG4); of specific antibodies against Haemophilus influenzae, Streptococcus pneumoniae (types 4, 6B, 9V, 14, 18C, 19F, 23F), CMV, VZV, tetanus, measles; and of glucose and maltose.
    Protection of trial subjects
    This trial was conducted in accordance to the principles of GCP, ensuring that the rights, safety and well-being of patients are protected and in consistency with the Declaration of Helsinki. Inclusion and exclusion criteria were carefully defined in order to protect subjects from contraindications, interactions with other medication and risk factors associated with the investigational medicinal product. Throughout the study safety was assessed, such as occurrence of AEs, safety labs, vital signs and physical examinations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    31 Mar 2009
    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: 2
    Country: Number of subjects enrolled
    Germany: 3
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was planned to be performed in patients with PID requiring antibody replacement therapy and who had received Octagam 5% replacement therapy at a steady dose and schedule for at least six infusions up to study entry

    Pre-assignment
    Screening details
    The study was planned to be performed in patients with PID requiring antibody replacement therapy and who had received Octagam 5% replacement therapy at a steady dose and schedule for at least six infusions up to study entry.Screening was to be performed between the end of the last pre-study infusion and the first infusion in the study

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

    Arms
    Arm title
    Octagam 10%
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Octagam 10% ,Human immunoglobulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Depending on the regular treatment intervals (every 3 or 4 weeks) the patient was to receive 17 or 13 infusions of Octagam 10% in the course of this study. The dose administered per kg body weight and the treatment intervals were to remain the same throughout the study, as long as trough levels of serum IgG were maintained above 5 g/L.

    Number of subjects in period 1
    Octagam 10%
    Started
    5
    Completed
    2
    Not completed
    3
         Early Termination of the study
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Enrolled Patients (Overall Study)
    Reporting group description
    -

    Reporting group values
    Enrolled Patients (Overall Study) Total
    Number of subjects
    5 5
    Age categorical
    Units: Subjects
        From 16-66 years
    5 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    31.4 ± 20.8 -
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    5 5

    End points

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    End points reporting groups
    Reporting group title
    Octagam 10%
    Reporting group description
    -

    Primary: Serum IgG trough levels before each administration (pre-next dose)

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    End point title
    Serum IgG trough levels before each administration (pre-next dose) [1]
    End point description
    Owing to the limited data available (only 5 patients enrolled, of whom 2 completed the study and 3 ended treatment prematurely), efficacy and PK analyses were not performed.
    End point type
    Primary
    End point timeframe
    Screening visit until the last study visit
    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: The study was terminated prematurely. Owing to the limited data available (only 5 patients enrolled, of whom 2 completed the study and 3 ended treatment prematurely), efficacy and PK analyses were not performed.
    End point values
    Octagam 10%
    Number of subjects analysed
    0 [2]
    Units: G/L
        number (not applicable)
    Notes
    [2] - Because of the premature termination no analyses was done
    No statistical analyses for this end point

    Primary: IgG-profile pharmacokinetics determined at the last but one (or last) infusion

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    End point title
    IgG-profile pharmacokinetics determined at the last but one (or last) infusion [3]
    End point description
    Owing to the limited data available (only 5 patients enrolled, of whom 2 completed the study and 3 ended treatment prematurely), efficacy and PK analyses were not performed.
    End point type
    Primary
    End point timeframe
    From screening visit to last visit of the study
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The study was terminated prematurely. Owing to the limited data available (only 5 patients enrolled, of whom 2 completed the study and 3 ended treatment prematurely), efficacy and PK analyses were not performed.
    End point values
    Octagam 10%
    Number of subjects analysed
    0 [4]
    Units: g/L
        number (not applicable)
    Notes
    [4] - Because of the premature termination no analyses was done
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed throughout the whole study from screening visit to the last visit of the study
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Octagam 10%
    Reporting group description
    -

    Serious adverse events
    Octagam 10%
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Condylomata Inguinal
    Additional description: surgical removal
         subjects affected / exposed
    1 / 5 (20.00%)
         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
    Octagam 10%
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 5 (80.00%)
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Surgical and medical procedures
    Wisdom teeth removal
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    2
    Dental operation
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Wart excision
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Investigations
    Urine uric acid abnormal
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2
    pharyngolaryngeal pain
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2
    Bronchitis chronic
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    2
    Epistaxis
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Wheezing
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Eye disorders
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Oropharyngeal plaque
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Joint effusion
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences all number
    3
    Gastroenteritis
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2
    Gastrointestinal infection
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Herpes zoster
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Onychomycosis
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Otitis media
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Subcutaneous abscess
         subjects affected / exposed
    1 / 5 (20.00%)
         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
    13 May 2009
    • Inclusion criterion of primary immunodeficiency requiring immunoglobulin replacement therapy must be associated with hypo- or agammaglobulinemia • Consistent dose to be infused is widened to 200 – 800 mg/kg BW • Update of drug safety section according to new drug safety SOP • Change of study duration • Terminology “anonymity/anonymous/anonymised” is replaced by appropriate wording

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Sep 2010
    The study was terminated prematurely on 30-Sep-2010 owing to temporary license suspension of Octagam 5% and 10%.
    -

    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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