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    Clinical Trial Results:
    Twelve-month study on the immunogenicity, safety, and efficacy of Zarzio®/Filgrastim HEXAL® in patients with severe chronic neutropenia

    Summary
    EudraCT number
    		 2011-001118-32
    Trial protocol
    		 DE   SE  
    Global end of trial date
    25 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2016
    First version publication date
    06 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EP06-401
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01859637
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sandoz GmbH
    Sponsor organisation address
    Biochemiestr. 10, Kundl, Austria, 6250
    Public contact
    Strategic Planning Biopharma Clinical Development, Sandoz , +49 8024 476 - 0, biopharma.clinicaltrials@sandoz.com
    Scientific contact
    Strategic Planning Biopharma Clinical Development, Sandoz , +49 8024 476 - 0, biopharma.clinicaltrials@sandoz.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the immunogenicity of long-term treatment of SCN patients with Sandoz’ filgrastim in terms of the incidence of anti-rhG-CSF antibodies.
    Protection of trial subjects
    The patients were recommended to be treated in adherene with the SmPC of Zarzio®/Hexal filgrastim® regarding dosage and administration, contraindications, warnings, precautions and undesirable effects. The investigator was to promote compliance by instructing the patient to take the study drug exactly as prescribed and by stating that compliance was necessary for the patient's safety. The patient was instructed to contact the investigator, if he/she was unable to take the study drug as prescribed for any reason.
    Background therapy
    		 NAP
    Evidence for comparator
    		 NAP
    Actual start date of recruitment
    01 Jun 2011
    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
    Sweden: 4
    Country: Number of subjects enrolled
    Germany: 2
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    5
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient first visit: 05-Jul-2011 Last patient first visit: 12-Feb-2013 Last patient last visit: 13-Mar-2014

    Pre-assignment
    Screening details
    		 The study enrolled adult patients with established congenital, cyclic or idiopathic severe chronic neutropenia. Eligible patients were either already on therapy with a rhG-CSF product or therapy-naïve patients who required rhG-CSF treatment.

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

    Arms
    Arm title
    		 Overall patients
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zarzio®/Hexal filgrastim®
    Investigational medicinal product code
    EP2006
    Other name
    Sandoz filgrastim®, Hexal filgrastim®, Zarzio®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 microg/0.5 ml (30 MU) in a syringe with a concentration of the compounded solution for filling of 600 microg/ml in a 0.5ml container 480 microg/0.5 ml (48 MU) in a syringe with a concentration of the compounded solution for filling of 960 microg/ml in a 0.5ml container

    Number of subjects in period 1
    		Overall patients
    Started
    6
    Completed
    6

    Baseline characteristics

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

    Reporting group values
    		 Overall patients Total
    Number of subjects
    		 6 6
    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)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 45 (27 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 1 1
    Severe chronic neutropenia
    Units: Subjects
        Congenital neutropenia
    		 1 1
        Cyclic neutropenia
    		 1 1
        Idiopathic neutropenia
    		 4 4
    G-CSF pre-treatment
    Units: Subjects
        Yes
    		 6 6
    Height
    Units: cm
        arithmetic mean (full range (min-max))
    		 165.7 (159 to 174) -
    Weight
    Units: kg
        arithmetic mean (full range (min-max))
    		 74.3 (55 to 98) -

    End points

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    End points reporting groups
    Reporting group title
    Overall patients
    Reporting group description
    		 -

    Primary: Absolute neutrophile count - values

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    End point title
    		 Absolute neutrophile count - values [1]
    End point description
    This was done to ensure that patients were effectively treated to avoid neutropenic complications
    End point type
    Primary
    End point timeframe
    At screening, baseline, week 6, month 3, month 6, month 9 and month 12 absolute neutrophile counts where measured
    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: As the study was stopped after 6 patients based on a decision making process with the EMA, only descriptive analyses was performed
    End point values
    		 Overall patients
    Number of subjects analysed
    6
    Units: 10^9/L
    median (full range (min-max))
        Screening
    2.3 (0.9 to 4.4)
        Baseline
    3.3 (0.8 to 12.2)
        Week 6
    10.2 (1 to 23.3)
        Month 3
    2.3 (1.2 to 28.8)
        Month 6
    2.9 (1.4 to 13.2)
        Month 9
    4.2 (1.4 to 21.6)
        Month 12
    4 (1.4 to 22.2)
    No statistical analyses for this end point

    Secondary: Absolute neurophile count - changes from baseline

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    End point title
    		 Absolute neurophile count - changes from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    Screening, week 6, month 3, month 6, month 9, month 12
    End point values
    		 Overall patients
    Number of subjects analysed
    6
    Units: 10^9/L
    median (full range (min-max))
        Screening
    -1.3 (-10.9 to 2.8)
        Week 6
    6.9 (-11.2 to 16.4)
        Month 3
    -0.2 (-11 to 25.5)
        Month 6
    -0.7 (-10.8 to 12.4)
        Month 9
    1.5 (-9.6 to 14.7)
        Month 12
    1.6 (-10.8 to 18.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    adverse events were recorded throughout the whole study duration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Overall patients
    Reporting group description
    		 -

    Serious adverse events
    		 Overall patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Renal and urinary disorders
    Nephrolithiasis
    Additional description: patient 0101 experienced severe nephrolithiasis leading to hospitalization. No action was taken re IMP. Event resolved completely 17 days after onset. No suspected relationship to investigational medicical product. Patient completed study as planned.
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Overall patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 6 (50.00%)
         occurrences all number
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Local swelling
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Skin induration
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 6 (50.00%)
         occurrences all number
    5
    Genital infection fungal
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Gingivitis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Groin abscess
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Herpes virus infection
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Mucosal infection
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Oral herpes
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Rash pustular
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    4
    Sinusitis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Subcutaneous abscess
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
         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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