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    Clinical Trial Results:
    A follow-up study to examine the presence of anti-human growth hormone (anti-hGH) antibodies following a randomised, open-label, parallel-group, multi-centre trial (FE 999905 CS07) in which the efficacy and safety of 12 months’ treatment with one daily dose of ZOMACTON were compared to one daily dose of GENOTROPIN.

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2014-000627-24
    Trial protocol
    HU   PL  
    Global end of trial date
    17 Aug 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Jun 2016
    First version publication date
    22 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    000134
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02173821
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ferring Pharmaceuticals A/S
    Sponsor organisation address
    Kay Fiskers Plads 11, Copenhagen S, Denmark, 2300
    Public contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    Scientific contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.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
    17 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the presence of remaining immunogenicity among previously anti-hGH antibody positive children who participated in the clinical study FE 999905 CS07 and were treated with one daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) or one daily dose of 0.03 mg/kg GENOTROPIN (12 mg/mL).
    Protection of trial subjects
    Before obtaining the consent from subject,parents(s)/legal representative, the Investigator appropriately explained the aims, methods, anticipated benefits, potential hazards, and any other aspects of the study which are relevant to the subjects' and parent(s)’/ legal representatives’ decision to participate. The Investigator explained to the subjects and their parent(s)/legal representatives about their right of freedom to refuse to enter the study or to withdraw from it at any time, without any consequences on subject's further care and without the need to justify their decision. The study was conducted in accordance with International Conference on Harmonization-Good Clinical Practice guidelines.
    Background therapy
    The enrolled subjects were treated with either one daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) or one daily dose of 0.03 mg/kg GENOTROPIN (12 mg/mL) for 12 months prior to participation in this follow-up study.
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Oct 2014
    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: 6
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    Ukraine: 8
    Worldwide total number of subjects
    23
    EEA total number of subjects
    8
    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)
    13
    Adolescents (12-17 years)
    10
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study 000134 was a follow-up of subjects treated with one daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) or one daily dose of 0.03 mg/kg GENOTROPIN (12 mg) in the previously completed study FE 999905 CS07 who had confirmed positive formation of anti-hGH antibodies in at least one post-dose visit during the 12-month treatment period.

    Pre-assignment
    Screening details
    The study was conducted to follow subjects who were anti-hGH antibody positive in at least one post-dosing sample in the study FE 999905 CS07.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ZOMACTON
    Arm description
    One daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No investigational medicinal product (IMP) was administered in the present follow-up study.
    Arm type
    Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    No IMP was administered in the present follow-up study.

    Arm title
    GENOTROPIN
    Arm description
    One daily dose of 0.03 mg/kg GENOTROPIN (12 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No IMP was administered in the present follow-up study.
    Arm type
    Active comparator

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    No IMP was administered in the present follow-up study.

    Number of subjects in period 1
    ZOMACTON GENOTROPIN
    Started
    22
    1
    Completed
    22
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ZOMACTON
    Reporting group description
    One daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No investigational medicinal product (IMP) was administered in the present follow-up study.

    Reporting group title
    GENOTROPIN
    Reporting group description
    One daily dose of 0.03 mg/kg GENOTROPIN (12 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No IMP was administered in the present follow-up study.

    Reporting group values
    ZOMACTON GENOTROPIN Total
    Number of subjects
    22 1 23
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    13 0 13
        Adolescents (12-17 years)
    9 1 10
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    11.5 ± 2.6 14.9 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    5 1 6
        Male
    17 0 17
    Race
    Units: Subjects
        Black or African American
    1 0 1
        White
    21 1 22
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0 0 0
        Not Hispanic or Latino
    22 1 23
    Height
    Units: Centimeters (cm)
        arithmetic mean (standard deviation)
    138 ± 14.787 160.5 ± 0 -
    Weight
    Units: Kilograms (kg)
        arithmetic mean (standard deviation)
    35.7 ± 11.632 48 ± 0 -
    Body Mass Index (BMI)
    Units: Kg/m^2
        arithmetic mean (standard deviation)
    18.23 ± 2.709 18.6 ± 0 -
    Duration from last visit of CS07 to follow-up visit
    Units: Years
        arithmetic mean (standard deviation)
    3.349 ± 0.454 3.65 ± 0 -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS comprised all enrolled subjects with an anti-hGH antibody measurement (and who were included in the FAS of the previous study FE 999905 CS07).

    Subject analysis sets values
    Full Analysis Set (FAS)
    Number of subjects
    23
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    13
        Adolescents (12-17 years)
    10
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    11.7 ± 2.63
    Gender categorical
    Units: Subjects
        Female
    6
        Male
    17
    Race
    Units: Subjects
        Black or African American
    1
        White
    22
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0
        Not Hispanic or Latino
    23
    Height
    Units: Centimeters (cm)
        arithmetic mean (standard deviation)
    138.97 ± 15.19
    Weight
    Units: Kilograms (kg)
        arithmetic mean (standard deviation)
    36.23 ± 11.65
    Body Mass Index (BMI)
    Units: Kg/m^2
        arithmetic mean (standard deviation)
    18.24 ± 2.648
    Duration from last visit of CS07 to follow-up visit
    Units: Years
        arithmetic mean (standard deviation)
    3.362 ± 0.447

    End points

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    End points reporting groups
    Reporting group title
    ZOMACTON
    Reporting group description
    One daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No investigational medicinal product (IMP) was administered in the present follow-up study.

    Reporting group title
    GENOTROPIN
    Reporting group description
    One daily dose of 0.03 mg/kg GENOTROPIN (12 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No IMP was administered in the present follow-up study.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS comprised all enrolled subjects with an anti-hGH antibody measurement (and who were included in the FAS of the previous study FE 999905 CS07).

    Primary: Prevalence of anti-hGH antibodies

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    End point title
    Prevalence of anti-hGH antibodies [1]
    End point description
    The prevalence of anti-hGH antibodies were estimated in the FAS by the percentage of subjects with positive anti-hGH antibodies and the exact 95% confidence interval (CI) (Clopper-Pearson) was provided.
    End point type
    Primary
    End point timeframe
    At Visit 1
    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: No hypothesis testing was conducted, and all statistics reported was descriptive. The data for immunogenicity was analysed and reported only for FAS, as FAS and Per Protocol analysis sets were identical.
    End point values
    ZOMACTON GENOTROPIN Full Analysis Set (FAS)
    Number of subjects analysed
    22
    1
    23
    Units: Percentage of subjects
        number (confidence interval 95%)
    18.2 (5.2 to 40.3)
    0 (0 to 97.5)
    17.4 (5 to 38.8)
    No statistical analyses for this end point

    Secondary: Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples

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    End point title
    Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples
    End point description
    The prevalence of neutralising antibodies in confirmed anti-hGH antibody positive samples were estimated in the FAS by the percentage of subjects with neutralising antibodies in the subgroup of subjects with confirmed anti-hGH antibodies positive samples and the associated exact 95% CI (Clopper-Pearson) was provided.
    End point type
    Secondary
    End point timeframe
    At Visit 1
    End point values
    ZOMACTON GENOTROPIN Full Analysis Set (FAS)
    Number of subjects analysed
    4
    0 [2]
    4
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0 to 60.2)
    ( to )
    0 (0 to 60.2)
    Notes
    [2] - No subject in this group was confirmed anti-hGH antibody positive.
    No statistical analyses for this end point

    Secondary: Binding capacity levels in confirmed anti-hGH antibody positive samples

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    End point title
    Binding capacity levels in confirmed anti-hGH antibody positive samples
    End point description
    The binding capacity in confirmed anti-hGH antibody positive samples were described using descriptive summary statistics. The percentage of subjects with binding capacity ≤2 mg/L (i.e. below the threshold of clinical significance) in subjects with confirmed anti-hGH antibody positive samples were provided (including the exact 95% CI [Clopper-Pearson]).
    End point type
    Secondary
    End point timeframe
    At Visit 1
    End point values
    ZOMACTON GENOTROPIN Full Analysis Set (FAS)
    Number of subjects analysed
    4
    0 [3]
    4
    Units: Percentage of subjects
        number (confidence interval 95%)
    100 (39.8 to 100)
    ( to )
    100 (39.8 to 100)
    Notes
    [3] - No subject in this group was confirmed anti-hGH antibody positive.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    No treatment-emergent adverse events were collected during the study period. Any adverse events that occurred were reported under medical history.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    Unknown
    Dictionary version
    0.0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Since no IMP was administered in this follow-up study, no adverse event data were collected. However, the investigator monitored the condition of the subject throughout the study from the time of obtaining informed consent until completion of the study. Any adverse events that occurred during this period were to be recorded under medical history.

    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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