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    Clinical Trial Results:
    An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infusion rates (Part B) in patients with primary immunodeficiency disease (PID)

    Summary
    EudraCT number
    		 2010-019249-25
    Trial protocol
    		 DE   HU  
    Global end of trial date
    12 Jan 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Sep 2021
    First version publication date
    15 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    981
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biotest AG
    Sponsor organisation address
    Landsteinerstr. 5, Dreieich, Germany, 63303
    Public contact
    Corporate Clinical Research and Development, Biotest AG, andrea.wartenberg-demand@biotest.com, Biotest AG, +49 6103801492, 981@biotest.de
    Scientific contact
    Corporate Clinical Research and Development, Biotest AG, andrea.wartenberg-demand@biotest.com, Biotest AG, +49 6103801492, 981@biotest.de
    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
    15 Sep 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jan 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigation of pharmacokinetics (Part A) and tolerability of BT090 at escalating infusion rates (Part B)
    Protection of trial subjects
    none
    Background therapy
    		 none
    Evidence for comparator
    		 not applicable
    Actual start date of recruitment
    15 Nov 2010
    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: 5
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Hungary: 16
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    2
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    23
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period from 15-Nov-2010 (first patient in) until 12-Jan-2012 (last patient out)

    Pre-assignment
    Screening details
    		 none

    Pre-assignment period milestones
    Number of subjects started
    		 30
    Number of subjects completed
    		 30

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

    Arms
    Arm title
    		 Part A + B
    Arm description
    		 PART A: Pharmacokinetics at 3rd infusion in week 6 or 8 (Cmax, tmax, t1/2el, AUC for serum concentration of IgG and IgG subclasses 1 to 4) and maintenance of IgG trough levels ≥5– 6 g/L. PART B: Tolerability and safety of escalating infusion rates for determination of a maximum tolerated rate. Tolerability was expressed as percentage of total patients being treated at the specified infusion rates on the basis of data received from the 5th and 6th infusions.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Human normal Immunoglobulin for intravenous use
    Investigational medicinal product code
    BT090
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    In the present trial, the planned monthly dose of BT090 is 200–800 mg/kg BW (2 8 mL/kg BW) administered as intravenous infusions in 3 or 4-week intervals for a treatment period of about 6 months. The dose and dosage intervals must be consistent with pre-trial standard IVIG treatment and are only to be changed if medically indicated The infusion rates will be increased from 0.3 to 1.4 to 2.0 mL/kg/h for each infusion in each patient at initially 30-minute intervals.

    Number of subjects in period 1
    		Part A + B
    Started
    30
    Completed
    24
    Not completed
    6
         Less than 2 samples between end of infusion and Da
    1
         Less than 2 samples between Day 7 and Day 21/28
    1
         At least one outlier in PK profile
    1
         PK dose of less than 200 mg/kg
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall (overall period) Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 2 2
        Adolescents (12-17 years)
    		 5 5
        Adults (18-64 years)
    		 23 23
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.7 ( 16.85 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 21 21
    Subject analysis sets

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of trial medication (full analysis set).

    Subject analysis set title
    PK Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All patients of the safety set with sufficient data for analysis of pharmacokinetic (PK) parameters.

    Subject analysis set title
    PP Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the safety set without any major protocol violations. Patients with major protocol deviations or incomplete documentation of relevant data or premature termination of the treatment due to reasons that were definitely not related to trial medication will be excluded from the per-protocol analysis.

    Subject analysis sets values
    		 Safety Set PK Analysis Set PP Set
    Number of subjects
    30
    24
    18
    Age categorical
    Units: Subjects
        Children (2-11 years)
    2
    1
    1
        Adolescents (12-17 years)
    5
    2
    2
        Adults (18-64 years)
    23
    21
    15
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    33.7 ( 16.85 )
    37 ( 16.05 )
    35.2 ( 16.8 )
    Gender categorical
    Units: Subjects
        Female
    9
    8
    5
        Male
    21
    16
    13

    End points

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    End points reporting groups
    Reporting group title
    Part A + B
    Reporting group description
    		 PART A: Pharmacokinetics at 3rd infusion in week 6 or 8 (Cmax, tmax, t1/2el, AUC for serum concentration of IgG and IgG subclasses 1 to 4) and maintenance of IgG trough levels ≥5– 6 g/L. PART B: Tolerability and safety of escalating infusion rates for determination of a maximum tolerated rate. Tolerability was expressed as percentage of total patients being treated at the specified infusion rates on the basis of data received from the 5th and 6th infusions.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of trial medication (full analysis set).

    Subject analysis set title
    PK Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All patients of the safety set with sufficient data for analysis of pharmacokinetic (PK) parameters.

    Subject analysis set title
    PP Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the safety set without any major protocol violations. Patients with major protocol deviations or incomplete documentation of relevant data or premature termination of the treatment due to reasons that were definitely not related to trial medication will be excluded from the per-protocol analysis.

    Primary: Serum IgG concentration (Cmax)

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    End point title
    		 Serum IgG concentration (Cmax) [1]
    End point description
    Standard Pharmacokinetic Parameter: the maximum observed serum IgG concentration
    End point type
    Primary
    End point timeframe
    At the 3rd infusion (week 6 or 8) standard pharmacokinetic parameters will be determined.
    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 descriptively summarised. No formal statistical tests were planned or performed.
    End point values
    		 Part A + B PK Analysis Set
    Number of subjects analysed
    24
    24
    Units: milligram(s)/dL
        median (full range (min-max))
    177 (130 to 217)
    177 (130 to 217)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Recording of AEs commences at the time when the patient is enrolled into the trial (date of signature of the informed consent) until the end of trial visit has been performed.
    Adverse event reporting additional description
    not applicable
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Safety Set
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 30 (10.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendiceal abscess
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 30 (3.33%)
         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
    		 Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 30 (90.00%)
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    4
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 30 (26.67%)
         occurrences all number
    11
    General disorders and administration site conditions
    Discomfort
         subjects affected / exposed
    5 / 30 (16.67%)
         occurrences all number
    6
    Fatigue
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    4
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    3
    Vomiting
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    4
    Back pain
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    5
    Bone pain
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    5 / 30 (16.67%)
         occurrences all number
    5
    Gastroenteritis
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    11 / 30 (36.67%)
         occurrences all number
    12
    Oral herpes
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Respiratory tract infection
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    5 / 30 (16.67%)
         occurrences all number
    5
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Apr 2011
    SA4 (Protocol Amendment 1) /Prot. Version 2.0: Adaptation of Inclusion criteria/ Section 11.4

    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
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