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    Clinical Trial Results:
    An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)

    Summary
    EudraCT number
    		 2015-003653-17
    Trial protocol
    		 DE   HU   ES   CZ   BG  
    Global end of trial date
    21 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Aug 2021
    First version publication date
    27 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    992
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02859909
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biotest AG
    Sponsor organisation address
    Landsteinerstr. 5, Dreieich, Germany, 63303
    Public contact
    Dr. med. Andrea Wartenberg-Demand, Biotest AG, +49 61038010, andrea.wartenberg-demand@biotest.com
    Scientific contact
    Dr. med. Andrea Wartenberg-Demand, Biotest AG, +49 61038010, andrea.wartenberg-demand@biotest.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002092-PIP01-16
    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
    21 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to assess the efficacy and safety of BT595 in adult subjects with chronic ITP. The primary objective of the study is to determine the rate of subjects with a response. A response is defined as a platelet count of ≥30*10^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding.
    Protection of trial subjects
    To monitor the safety data from adult subjects and to provide advice and recommendations on the enrollment a DSMB consisting of independent experts has been implemented.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Aug 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Bulgaria: 5
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 14
    Country: Number of subjects enrolled
    Serbia: 13
    Worldwide total number of subjects
    34
    EEA total number of subjects
    21
    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)
    0
    Adults (18-64 years)
    27
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of first enrollment 09-Jan-2017, first IMP administration 17-Jan-2017, date of last subject completed 21-Dec-2018

    Pre-assignment
    Screening details
    		 Diagnosis of chronic ITP, male or female, age 18 through 75 (inclusive), mean screening platelet count of <30*10^9/L from 3 qualifying platelet counts and no individual platelet count above 35*10^9/L, high risk of bleeding

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

    Arms
    Arm title
    		 Full Analysis Set
    Arm description
    		 Subjects were treated with a total of 2 g/kg body weight (bw) administered as intravenous infusion for 2 or 5 consecutive days, i.e. subjects were treated for 2 consecutive days with 1 g/kg bw per day or for 5 consecutive days with 0.4 g/kg bw per day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IgG Next Generation
    Investigational medicinal product code
    BT595
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2 g/kg body weight (bw) administered as intravenous infusion for 2 or 5 consecutive days.

    Number of subjects in period 1
    		Full Analysis Set
    Started
    34
    Completed
    33
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full Analysis Set
    Reporting group description
    		 Subjects were treated with a total of 2 g/kg body weight (bw) administered as intravenous infusion for 2 or 5 consecutive days, i.e. subjects were treated for 2 consecutive days with 1 g/kg bw per day or for 5 consecutive days with 0.4 g/kg bw per day.

    Reporting group values
    		 Full Analysis Set Total
    Number of subjects
    		 34 34
    Age categorical
    Adult 18-75 years
    Units: Subjects
        Age 18-75
    		 34 34
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    Full Analysis Set
    Reporting group description
    		 Subjects were treated with a total of 2 g/kg body weight (bw) administered as intravenous infusion for 2 or 5 consecutive days, i.e. subjects were treated for 2 consecutive days with 1 g/kg bw per day or for 5 consecutive days with 0.4 g/kg bw per day.

    Subject analysis set title
    Full Analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis and safety analysis set is identical and includes all subjects who received ≥ 1 dose of BT595.

    Primary: Rate of subjects with Response

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    End point title
    		 Rate of subjects with Response
    End point description
    Rate of subjects with R: defined as subjects with a platelet count of ≥30*10^9/L and at least a 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding.
    End point type
    Primary
    End point timeframe
    Rate of subjects with R: defined as subjects with a platelet count of ≥30*10^9/L and at least a 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding.
    End point values
    		 Full Analysis Set Full Analysis set
    Number of subjects analysed
    34
    34
    Units: numbers
    1
    1
    Statistical analysis title
    		 Primary Analysis rate of response
    Comparison groups
    Full Analysis Set v Full Analysis set
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Response Rate
    Point estimate
    52.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35.1
         upper limit
    		 70.2
    Notes
    [1] - The primary endpoint will be analyzed using the 2-sided 95% CI for response rate, which will be calculated for each treatment schedule and overall using exact binomial distribution.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Observation period, Visit 1-13, until day 36
    Adverse event reporting additional description
    On site visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Full Analysis Set
    Reporting group description
    		 Full Analysis Set and Saftey Analysis Set are identical and include all subjects who received ≥ 1 dose of BT595.

    Serious adverse events
    		 Full Analysis Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 34 (2.94%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Full Analysis Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 34 (79.41%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Haematoma
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Chest discomfort
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Asthma
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Investigations
    Coombs direct test positive
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    4
    Platelet count decreased
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    5
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Subcutaneous haematoma
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    4
    Accidental overdose
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 34 (20.59%)
         occurrences all number
    9
    Blood and lymphatic system disorders
    Haemolysis
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    Intravascular haemolysis
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Gastrointestinal disorders
    Gingival bleeding
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    5
    Angina bullosa haemorrhagica
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Petechiae
         subjects affected / exposed
    8 / 34 (23.53%)
         occurrences all number
    11
    Ecchymosis
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    5
    Rash
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    Blood blister
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Skin reaction
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    2
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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