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    Clinical Trial Results:
    A phase IV open-label study of predictive markers in Growth Hormone Deficient and Turner Syndrome pre-pubertal children treated with SAIZEN®

    Summary
    EudraCT number
    2004-005054-31
    Trial protocol
    GB   FI   ES   DE   AT   SE   IT  
    Global end of trial date
    17 Sep 2007

    Results information
    Results version number
    v1(current)
    This version publication date
    23 May 2016
    First version publication date
    31 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    24531
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck Serono, a division of Merck KGaA
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Communication Centre merck KGaA, Merck KGaA, Merck Serono, a division of Merck KGaA, 49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Centre merck KGaA, Merck KGaA, Merck Serono, a division of Merck KGaA, 49 6151725200, service@merckgroup.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 Sep 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify the most responsive serum biomarkers after one month of SAIZEN® therapy in growth hormone deficiency (GHD) and Turner syndrome (TS) children.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 May 2005
    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
    Argentina: 24
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Finland: 2
    Country: Number of subjects enrolled
    France: 46
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Italy: 31
    Country: Number of subjects enrolled
    Norway: 7
    Country: Number of subjects enrolled
    Russian Federation: 73
    Country: Number of subjects enrolled
    Spain: 49
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    Taiwan: 15
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 31
    Worldwide total number of subjects
    318
    EEA total number of subjects
    158
    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)
    3
    Children (2-11 years)
    249
    Adolescents (12-17 years)
    65
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    First/last subject (informed consent): Dec 2013/xxxxxxx. Clinical data cutoff: Oct 2007, Study completion date: Sep 2007.

    Pre-assignment
    Screening details
    A total of 319 subjects were screened for this trial. Only 1 subject withdrew from the study prior receiving the treatment due to personal reasons. Overall, 318 subjects were enrolled into the study.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Turner Syndrome (TS)
    Arm description
    Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
    Arm type
    Experimental

    Investigational medicinal product name
    SAIZEN®
    Investigational medicinal product code
    Other name
    Somatropin
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SAIZEN® was administered as subcutaneous injection at a dose of 0.050 mg/kg of body weight per day for a period of 1 month.

    Arm title
    Growth Hormone Deficiency (GHD)
    Arm description
    Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
    Arm type
    Experimental

    Investigational medicinal product name
    SAIZEN®
    Investigational medicinal product code
    Other name
    Somatropin
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SAIZEN® was administered as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day for a period of 1 month.

    Number of subjects in period 1
    Turner Syndrome (TS) Growth Hormone Deficiency (GHD)
    Started
    149
    169
    Completed
    147
    167
    Not completed
    2
    2
         Adverse event
    1
    -
         Unspecified
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Turner Syndrome (TS)
    Reporting group description
    Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.

    Reporting group title
    Growth Hormone Deficiency (GHD)
    Reporting group description
    Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.

    Reporting group values
    Turner Syndrome (TS) Growth Hormone Deficiency (GHD) Total
    Number of subjects
    149 169
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    9.3 ± 4.08 8.94 ± 3.17 -
    Gender, Male/Female
    Units: participants
        Female
    149 63 212
        Male
    0 106 106

    End points

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    End points reporting groups
    Reporting group title
    Turner Syndrome (TS)
    Reporting group description
    Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.

    Reporting group title
    Growth Hormone Deficiency (GHD)
    Reporting group description
    Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.

    Primary: Change from baseline in insulin like growth factor-1 standard deviation score (IGF-1 SDS) levels at month 1

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    End point title
    Change from baseline in insulin like growth factor-1 standard deviation score (IGF-1 SDS) levels at month 1 [1]
    End point description
    IGF-1 SDS was calculated using the Elmlinger reference method. This endpoint was assessed within-subject change in IGF-1 levels (standard deviation scores) at month 1 from baseline. Descriptive statistics were determined for the baseline and month 1 assessments, and also for the level of change between these two assessments. If either the baseline or month 1 IGF-1 level was missing, then the within-subject change in IGF-1 was assumed to be missing. This endpoint was assessed in Intention to Treat (ITT) population with evaluable subjects. The ITT population included all subjects who received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Month 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: Statistical analysis are presented in a separate attachment "hange from baseline in insulin like growth factor-1 standard deviation score (IGF-1 SDS) levels at month 1".
    End point values
    Turner Syndrome (TS) Growth Hormone Deficiency (GHD)
    Number of subjects analysed
    143
    162
    Units: Standard deviation score (SDS)
        arithmetic mean (standard deviation)
    1.7692 ± 1.1889
    1.4007 ± 0.9811
    Attachments
    Statistical Analysis
    No statistical analyses for this end point

    Secondary: Change from baseline in insulin-like growth factor binding protein - 3 (IGFBP-3) level at month 1

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    End point title
    Change from baseline in insulin-like growth factor binding protein - 3 (IGFBP-3) level at month 1
    End point description
    This endpoint was assessed in ITT population with evaluable subjects.
    End point type
    Secondary
    End point timeframe
    Month 1
    End point values
    Turner Syndrome (TS) Growth Hormone Deficiency (GHD)
    Number of subjects analysed
    143
    162
    Units: milligram per liter (mg/L)
        arithmetic mean (standard deviation)
    0.86 ± 0.96
    0.69 ± 0.81
    No statistical analyses for this end point

    Secondary: Change from baseline in fasting glucose levels at month 1

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    End point title
    Change from baseline in fasting glucose levels at month 1
    End point description
    This endpoint was assessed in ITT population with evaluable subjects.
    End point type
    Secondary
    End point timeframe
    Month 1
    End point values
    Turner Syndrome (TS) Growth Hormone Deficiency (GHD)
    Number of subjects analysed
    122
    142
    Units: millimoles per liter (mmol/L)
        arithmetic mean (standard deviation)
    0.22 ± 0.8
    0.13 ± 0.65
    No statistical analyses for this end point

    Secondary: Change from baseline in fasting insulin levels at month 1

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    End point title
    Change from baseline in fasting insulin levels at month 1
    End point description
    This endpoint was assessed in ITT population with evaluable subjects.
    End point type
    Secondary
    End point timeframe
    Month 1
    End point values
    Turner Syndrome (TS) Growth Hormone Deficiency (GHD)
    Number of subjects analysed
    142
    160
    Units: picomole per liter (pmol/L)
        arithmetic mean (standard deviation)
    47.7 ± 177.2
    26.9 ± 79.8
    No statistical analyses for this end point

    Secondary: Change from baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at month 1

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    End point title
    Change from baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at month 1
    End point description
    HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5. This endpoint was assessed in ITT population with evaluable subjects. This endpoint was assessed in ITT popuation with evaluable subjects.
    End point type
    Secondary
    End point timeframe
    Month 1
    End point values
    Turner Syndrome (TS) Growth Hormone Deficiency (GHD)
    Number of subjects analysed
    120
    136
    Units: picomole per liter *millimole per liter
        arithmetic mean (standard deviation)
    2.132 ± 10.296
    1.061 ± 3.885
    No statistical analyses for this end point

    Secondary: Change from baseline in bone alkaline phosphatase levels at month 1

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    End point title
    Change from baseline in bone alkaline phosphatase levels at month 1
    End point description
    This endpoint was assessed in ITT population with evaluable subjects.
    End point type
    Secondary
    End point timeframe
    Month 1
    End point values
    Turner Syndrome (TS) Growth Hormone Deficiency (GHD)
    Number of subjects analysed
    144
    162
    Units: Units per liter (U/L)
        arithmetic mean (standard deviation)
    21.13 ± 80.68
    14.78 ± 25.23
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were captured from the date of informed consent until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period.
    Adverse event reporting additional description
    Treatment-emergent adverse events were defined as those events having an onset date greater than or equal to the first dose date of the study medication and less than or equal to the last dose date plus 28 days.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Turner Syndrome
    Reporting group description
    Subjects with Turner Syndrome were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 mg/kg of body weight (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.

    Reporting group title
    Growth Hormone Deficiency
    Reporting group description
    Growth hormone deficiency subjects were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.

    Serious adverse events
    Turner Syndrome Growth Hormone Deficiency
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Tonsillitis streptococcal
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Turner Syndrome Growth Hormone Deficiency
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 149 (24.16%)
    51 / 169 (30.18%)
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    6 / 149 (4.03%)
    9 / 169 (5.33%)
         occurrences all number
    7
    9
    Injection site haemorrhage
         subjects affected / exposed
    1 / 149 (0.67%)
    1 / 169 (0.59%)
         occurrences all number
    1
    1
    Injection site irritation
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    2
    Fatigue
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 169 (0.00%)
         occurrences all number
    1
    0
    Injection site anaesthesia
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 169 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Affect lability
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 169 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 149 (3.36%)
    2 / 169 (1.18%)
         occurrences all number
    7
    2
    Productive cough
         subjects affected / exposed
    3 / 149 (2.01%)
    0 / 169 (0.00%)
         occurrences all number
    5
    0
    Pharyngolaryngeal pain
         subjects affected / exposed
    1 / 149 (0.67%)
    1 / 169 (0.59%)
         occurrences all number
    1
    1
    Epistaxis
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 169 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 169 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 149 (5.37%)
    12 / 169 (7.10%)
         occurrences all number
    10
    18
    Dizziness
         subjects affected / exposed
    2 / 149 (1.34%)
    1 / 169 (0.59%)
         occurrences all number
    3
    2
    Somnolence
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 149 (0.67%)
    1 / 169 (0.59%)
         occurrences all number
    1
    1
    Ear pain
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 169 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    3 / 149 (2.01%)
    4 / 169 (2.37%)
         occurrences all number
    3
    4
    Diarrhoea
         subjects affected / exposed
    1 / 149 (0.67%)
    3 / 169 (1.78%)
         occurrences all number
    1
    3
    Abdominal pain
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Enteritis
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Dermatitis atopic
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    2
    Back pain
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Endocrine disorders
    Precocious puberty
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 149 (2.68%)
    2 / 169 (1.18%)
         occurrences all number
    4
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 149 (2.01%)
    2 / 169 (1.18%)
         occurrences all number
    4
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 149 (0.67%)
    2 / 169 (1.18%)
         occurrences all number
    2
    2
    Ear infection
         subjects affected / exposed
    2 / 149 (1.34%)
    0 / 169 (0.00%)
         occurrences all number
    2
    0
    Influenza
         subjects affected / exposed
    1 / 149 (0.67%)
    1 / 169 (0.59%)
         occurrences all number
    1
    1
    Pharyngitis
         subjects affected / exposed
    0 / 149 (0.00%)
    2 / 169 (1.18%)
         occurrences all number
    0
    2
    Tonsillitis
         subjects affected / exposed
    1 / 149 (0.67%)
    1 / 169 (0.59%)
         occurrences all number
    1
    1
    Bronchitis
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Bronchitis acute
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Conjunctivitis viral
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Enterocolitis infectious
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Otitis externa
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Skin infection
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 169 (0.59%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 May 2007
    The purpose of this amendment was to modify the primary endpoint from "change from baseline in IGF-1" levels at month 1 to "Change from baseline in IGF-1 SDS" levels at month 1.

    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.
    Limitations of the trial were short duration of the study treatment, and relatively small sample size
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