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    Clinical Trial Results:
    Optimization of the dosage regimen with growth hormone therapy in children born small for gestational age. An open label, randomized pilot study, comparing in children treated for 3 years, the efficacy of a Saizen® treatment at the same dose versus a lower maintenance dose prolonged during 1 additional year (SGA OPTIMIS)

    Summary
    EudraCT number
    		 2015-001696-51
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Sep 2007

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

    Trial information

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    Trial identification
    Sponsor protocol code
    25735
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00249821
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck KGaA
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Communication Centre merck KGaA, Merck KGaA, +49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Centre Merck KGaA, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Sep 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Sep 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Sep 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluating the benefit in terms of height gain of a fourth year of an recombinant human growth hormone (r-hGH) induction regimen with a daily dose of 0.057 milligram /kilogram/day (mg/kg/day) in comparison to a maintenance regimen at a lower daily dose of 0.035 mg/kg/day, after an initial 3-year period at the induction dose of 0.057mg/kg/day in subjects born Small for gestational age (SGA).
    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
    28 Feb 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
    France: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    Adolescents (12-17 years)
    0
    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
    		 First subject signed informed consent form: February 28, 2005. Clinical data cutoff: September 12, 2007, Study completion date: September 12, 2007.

    Pre-assignment
    Screening details
    		 A total of 22 subjects were included in the trial.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Saizen® 0.035 mg/kg/day
    Arm description
    		 Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Saizen
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.

    Arm title
    		 Saizen® 0.057 mg/kg/day
    Arm description
    		 Saizen® r-hGH subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Saizen
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.

    Number of subjects in period 1
    		Saizen® 0.035 mg/kg/day Saizen® 0.057 mg/kg/day
    Started
    12
    10
    Completed
    11
    10
    Not completed
    1
    0
         Technical problem
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Saizen® 0.057 mg/kg/day
    Reporting group description
    		 Saizen® r-hGH subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.

    Reporting group title
    Saizen® 0.035 mg/kg/day
    Reporting group description
    		 Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.

    Reporting group values
    		 Saizen® 0.057 mg/kg/day Saizen® 0.035 mg/kg/day Total
    Number of subjects
    		 10 12 22
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.9 ( 0.9 ) 8 ( 1.49 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 4 4 8
        Male
    		 6 8 14

    End points

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    End points reporting groups
    Reporting group title
    Saizen® 0.035 mg/kg/day
    Reporting group description
    		 Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.

    Reporting group title
    Saizen® 0.057 mg/kg/day
    Reporting group description
    		 Saizen® r-hGH subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.

    Primary: Height Velocity

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    End point title
    		 Height Velocity
    End point description
    Height Velocity (HV) is the change in height since the previous year´s measurement and more precisely: HV = {(h-hp)/(d-dp)} * 365.25 [centimeter (cm)/year] where h is current height in cm, hp is previous height in cm, closest to 1 year previous, d is the current date and dp is the date of measurement of previous height, closest to 1 year previous. Additionally, d and dp have to be within 0.6 years and 1.5 years. HV is the mean height velocity over the interval between d and dp but is displayed as HV at d. Full Analysis (FA) set included all the subjects who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Last observation carried forward (LOCF) was used to impute missing values.
    End point type
    Primary
    End point timeframe
    Month 12
    End point values
    		 Saizen® 0.057 mg/kg/day Saizen® 0.035 mg/kg/day
    Number of subjects analysed
    10
    12
    Units: centimeter (cm)/year
        arithmetic mean (standard deviation)
    6.4 ( 1.35 )
    4.4 ( 1.15 )
    Statistical analysis title
    		 Statistical Analysis for Height Velocity
    Statistical analysis description
    Month 12: Analysis of co-variance (ANCOVA) method with covariates “height” and “age” at baseline was used to calculate presented p-value.
    Comparison groups
    Saizen® 0.057 mg/kg/day v Saizen® 0.035 mg/kg/day
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12

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    End point title
    		 Change from baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12
    End point description
    Height-Standard Deviation Score (H-SDS) was calculated as height minus mean (age-and sex-matched reference) divided by standard deviation (SD) [age and sex-matched reference]. Greater H-SDS indicates greater height. FA set included all the subjects who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values.
    End point type
    Secondary
    End point timeframe
    Baseline (randomization), Month 6 and Month 12
    End point values
    		 Saizen® 0.057 mg/kg/day Saizen® 0.035 mg/kg/day
    Number of subjects analysed
    10
    12
    Units: standard deviation score
    arithmetic mean (standard deviation)
        Baseline (randomization)
    -1.3 ( 0.42 )
    -1.5 ( 0.37 )
        Change at Month 6
    0.3 ( 0.22 )
    0.1 ( 0.1 )
        Change at Month 12
    0.3 ( 0.3 )
    -0.1 ( 0.24 )
    Statistical analysis title
    		 Statistical analysis H-SDS: Month 6
    Statistical analysis description
    Change at Month 6: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.
    Comparison groups
    Saizen® 0.057 mg/kg/day v Saizen® 0.035 mg/kg/day
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.012
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis H-SDS: Month 12
    Statistical analysis description
    Change at Month 12: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.
    Comparison groups
    Saizen® 0.057 mg/kg/day v Saizen® 0.035 mg/kg/day
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Height velocity-Standard deviation score (HV-SDS)

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    End point title
    		 Height velocity-Standard deviation score (HV-SDS)
    End point description
    Height Velocity-Standard Deviation Score (HV-SDS) was calculated as height velocity minus reference mean height velocity divided by SD of the reference mean height velocity. Greater HV-SDS indicates greater height velocity. FA set included all the subjects who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Here "n" signifies number of subjects analyzed at that particular time point for each arm group respectively. LOCF was used to impute missing values.
    End point type
    Secondary
    End point timeframe
    Month 6 and Month 12
    End point values
    		 Saizen® 0.057 mg/kg/day Saizen® 0.035 mg/kg/day
    Number of subjects analysed
    10
    12
    Units: standard deviation score
    arithmetic mean (standard deviation)
        Month 6 (n= 10,11)
    0.6 ( 0.44 )
    0.1 ( 0.22 )
        Month 12 (n=10,12)
    0.3 ( 0.29 )
    -0.1 ( 0.24 )
    Statistical analysis title
    		 Statistical analysis HV-SDS: Month 6
    Statistical analysis description
    Month 6: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.
    Comparison groups
    Saizen® 0.057 mg/kg/day v Saizen® 0.035 mg/kg/day
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.022
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis HV-SDS: Month 12
    Statistical analysis description
    Month 12: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.
    Comparison groups
    Saizen® 0.057 mg/kg/day v Saizen® 0.035 mg/kg/day
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in height at Month 6

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    End point title
    		 Change from baseline in height at Month 6
    End point description
    FA set included all the subjects who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values.
    End point type
    Secondary
    End point timeframe
    Baseline (randomization) and Month 6
    End point values
    		 Saizen® 0.057 mg/kg/day Saizen® 0.035 mg/kg/day
    Number of subjects analysed
    10
    12
    Units: cm
    arithmetic mean (standard deviation)
        Baseline (randomization)
    121.1 ( 7.99 )
    119.2 ( 5.29 )
        Change at Month 6
    3.6 ( 1.31 )
    2.5 ( 0.99 )
    Statistical analysis title
    		 Statistical Analysis:change from baseline height
    Statistical analysis description
    Change at Month 6: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.
    Comparison groups
    Saizen® 0.057 mg/kg/day v Saizen® 0.035 mg/kg/day
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.029
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in bone age at Month 12

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    End point title
    		 Change from baseline in bone age at Month 12
    End point description
    Bone age was assessed by a left wrist X-Ray and evaluated by the investigator according to the Greulich and Pyle method.FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of subjects analyzed) signified those participants who were evaluable for this measure and "n" = number of subjects analyzed at that particular time point for each arm group respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (randomization) and Month 12
    End point values
    		 Saizen® 0.057 mg/kg/day Saizen® 0.035 mg/kg/day
    Number of subjects analysed
    9
    10
    Units: years
    arithmetic mean (standard deviation)
        Baseline (randomization) (n = 9,10)
    7.5 ( 0.82 )
    7 ( 1.85 )
        Change at Month 12 (n=9,7)
    1.4 ( 0.79 )
    1.4 ( 0.89 )
    Statistical analysis title
    		 Statistical Analysis:change from baseline: height
    Statistical analysis description
    Change at Month 12: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.
    Comparison groups
    Saizen® 0.057 mg/kg/day v Saizen® 0.035 mg/kg/day
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.972
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Insulin Like Growth Factor-1 (IGF-1) Levels

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    End point title
    		 Insulin Like Growth Factor-1 (IGF-1) Levels
    End point description
    FA set included all subjects who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of subjects analyzed) signified those participants who were evaluable for this measure and "n" = number of subjects analyzed at that particular time point for each arm group respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (randomization), Month 6 and Month 12
    End point values
    		 Saizen® 0.057 mg/kg/day Saizen® 0.035 mg/kg/day
    Number of subjects analysed
    10
    11
    Units: microgram/liter (mcg/L)
    arithmetic mean (standard deviation)
        Baseline (randomization) (n= 10,11)
    319.6 ( 146.27 )
    275.4 ( 98.82 )
        Month 6 (n= 9,7)
    369.3 ( 120.13 )
    262.4 ( 65.52 )
        Month 12 (n=10,10)
    414.3 ( 176.7 )
    263 ( 120.7 )
    Statistical analysis title
    		 Statistical Analysis:IGF-1 Month 6
    Statistical analysis description
    Month 6: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.
    Comparison groups
    Saizen® 0.057 mg/kg/day v Saizen® 0.035 mg/kg/day
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.058
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
    Statistical analysis title
    		 Statistical Analysis:IGF-1 Month 12
    Statistical analysis description
    Month 12: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.
    Comparison groups
    Saizen® 0.057 mg/kg/day v Saizen® 0.035 mg/kg/day
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.026
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels

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    End point title
    		 Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels
    End point description
    FA set included all subjects who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of subjects analyzed) signified those subjects who were evaluable for this measure and "n" = number of subjects analyzed at that particular time point for each arm group respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (randomization), Month 6 and Month 12
    End point values
    		 Saizen® 0.057 mg/kg/day Saizen® 0.035 mg/kg/day
    Number of subjects analysed
    10
    10
    Units: milligram/L (mg/L)
    arithmetic mean (standard deviation)
        Baseline (randomization) (n= 10,10)
    3.4 ( 0.7 )
    3.4 ( 0.6 )
        Month 6 (n= 9,7)
    3 ( 0.84 )
    3.3 ( 0.81 )
        Month 12 (n= 9,10)
    3.6 ( 1.02 )
    3.5 ( 0.77 )
    Statistical analysis title
    		 Statistical Analysis:IGBP-3: Month 6
    Statistical analysis description
    Month 6: ANCOVA method with covariates "height" and "age" at baseline was used to calculate presented p-value.
    Comparison groups
    Saizen® 0.057 mg/kg/day v Saizen® 0.035 mg/kg/day
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.793
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis:IGBP-3: Month 12
    Statistical analysis description
    Month 12: ANCOVA method with covariates "height" and "age" at baseline was used to calculate presented p-value.
    Comparison groups
    Saizen® 0.057 mg/kg/day v Saizen® 0.035 mg/kg/day
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.055
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Number of subjectss with treatment emergent adverse events (TEAEs)

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    End point title
    		 Number of subjectss with treatment emergent adverse events (TEAEs)
    End point description
    Adverse Events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the Investigational Medicinal Product (IMP). The safety population included all the subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline (randomization) until Month 12
    End point values
    		 Saizen® 0.057 mg/kg/day Saizen® 0.035 mg/kg/day
    Number of subjects analysed
    10
    12
    Units: Subjects
        number (not applicable)
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until 4 weeks post drug administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
    Adverse event reporting additional description
    Pre-Treatment:Medical conditions present at initial study visit that did not worsen in severity or frequency during study;Treatment-Emergent: If onset date of AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of AE was post 4 weeks after drug administration for subjects who completed the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Saizen® 0.035 mg/kg/day
    Reporting group description
    		 Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.

    Reporting group title
    Saizen® 0.057 mg/kg/day
    Reporting group description
    		 Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.

    Serious adverse events
    		 Saizen® 0.035 mg/kg/day Saizen® 0.057 mg/kg/day
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Saizen® 0.035 mg/kg/day Saizen® 0.057 mg/kg/day
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 10 (20.00%)
    Investigations
    Insulin-like growth factor increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Immune system disorders
    Asthma
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2

    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.
    Subject's inclusion period was extended but due to remaining low recruitment rate, it was finally decided to stop enrollment even if only 22 subjects were enrolled.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22508151
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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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