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    Clinical Trial Results:
    Open-label, single-arm, Phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD)

    Summary
    EudraCT number
    2012-004263-47
    Trial protocol
    GB   SE   DE   CZ  
    Global end of trial date
    21 Mar 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Mar 2017
    First version publication date
    03 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EMR200104-011
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01806298
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck KGaA
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Communication Center Merck KGaA, Merck KGaA, +49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Center 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether the marketed Saizen solution for injection, administered according to the approved label for 9 months (39 weeks) in adults with GHD, induces the development of binding antibodies (BAbs).
    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 Jun 2013
    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
    United Kingdom: 28
    Country: Number of subjects enrolled
    Australia: 31
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    Germany: 9
    Worldwide total number of subjects
    78
    EEA total number of subjects
    47
    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)
    76
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    First subject enrolled: 28 Jun 2013; Last subject visited on: 21 Mar 2016

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

    Arms
    Arm title
    Saizen®
    Arm description
    Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
    Arm type
    Experimental

    Investigational medicinal product name
    Saizen®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Saizen® solution for injection was administered subcutaneously once daily for 39 weeks.

    Number of subjects in period 1
    Saizen®
    Started
    78
    Completed
    68
    Not completed
    10
         Other
    5
         Protocol Non-compliance
    1
         Consent withdrawn by subject
    1
         Adverse Event
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®. The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®.

    Reporting group values
    Overall Study Total
    Number of subjects
    78 78
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    44.5 ± 12.61 -
    Gender categorical
    Units: Subjects
        Female
    30 30
        Male
    48 48

    End points

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    End points reporting groups
    Reporting group title
    Saizen®
    Reporting group description
    Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.

    Primary: Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®

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    End point title
    Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen® [1]
    End point description
    Percentage of subjects developing BAbs = (Number of BAb positive subjects / Total number of subjects) x 100. The modified Intent-To-Treat (mITT) analysis set included all treated subjects who had received at least 1 administration of Saizen® and had at least 1 post-baseline BAbs assessment.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 39
    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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Saizen®
    Number of subjects analysed
    77
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0 to 4.68)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Binding Antibodies (BAbs) Who Became Positive for Neutralizing Antibodies (NAbs)

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    End point title
    Percentage of Subjects With Binding Antibodies (BAbs) Who Became Positive for Neutralizing Antibodies (NAbs)
    End point description
    Percentage of subjects with BAbs who become positive for NAbs = (Number of NAb positive subjects / Number of BAbs positive subjects) x 100.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 39
    End point values
    Saizen®
    Number of subjects analysed
    0 [2]
    Units: percentage of subjects
    Notes
    [2] - Data could not be analysed as there were no subjects who were BAb positive.
    No statistical analyses for this end point

    Secondary: Insulin-like Growth Factor-I (IGF-I) Levels

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    End point title
    Insulin-like Growth Factor-I (IGF-I) Levels
    End point description
    Growth Hormone (GH) biomarker levels were summarised by GH treatment status at study entry (that is subjects were classified as GH treatment-naïve subjects or subjects with prior GH treatment for adult growth hormone deficiency [AGHD]). The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, "n" signifies those subjects who were evaluable for the specified category at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 8, 16, 29, 39 and 41
    End point values
    Saizen®
    Number of subjects analysed
    78
    Units: nanomoles per litre (nmol/L)
    arithmetic mean (standard deviation)
        GH Treatment-naive: Baseline (n = 64)
    14.54 ± 7.219
        Previously took GH treatment : Baseline (n = 14)
    10.91 ± 4.744
        GH Treatment-naive: Week 2 (n = 64)
    21.15 ± 9.008
        Previously took GH treatment: Week 2 (n = 14)
    19.41 ± 5.804
        GH Treatment-naive: Week 8 (n = 63)
    23.41 ± 9.07
        Previously took GH treatment: Week 8 (n = 13)
    20.91 ± 5.437
        GH Treatment-naive: Week 16 (n = 59)
    22.34 ± 6.844
        Previously took GH treatment: Week 16 (n = 13)
    20.15 ± 7.381
        GH Treatment-naive: Week 29 (n = 59)
    25.07 ± 8.026
        Previously took GH treatment: Week 29 (n = 13)
    20.9 ± 6.81
        GH Treatment-naive: Week 39 (n = 61)
    23.82 ± 7.961
        Previously took GH treatment: Week 39 (n = 14)
    20.56 ± 8.486
        GH Treatment-naive: Week 41 ( n = 56)
    15.28 ± 6.943
        Previously took GH treatment: Week 41 (n = 12)
    12.12 ± 4.91
    No statistical analyses for this end point

    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
    Growth Hormone (GH) biomarker levels were summarised by GH treatment status at study entry (that is subjects were classified as GH treatment-naïve subjects or subjects with prior GH treatment for adult growth hormone deficiency [AGHD]). The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, "n" signifies those subjects who were evaluable for the specified category at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 8, 16, 29, 39 and 41
    End point values
    Saizen®
    Number of subjects analysed
    78
    Units: milligram/liter (mg/L)
    arithmetic mean (standard deviation)
        GH Treatment-naive: Baseline (n = 64)
    2.62 ± 0.843
        Previously took GH treatment : Baseline (n = 14)
    2.2 ± 0.68
        GH Treatment-naive: Week 2 (n = 64)
    3.03 ± 0.872
        Previously took GH treatment: Week 2 (n = 14)
    2.85 ± 0.981
        GH Treatment-naive: Week 8 (n = 63)
    3.11 ± 0.831
        Previously took GH treatment: Week 8 (n = 13)
    2.77 ± 0.795
        GH Treatment-naive: Week 16 (n = 59)
    3.15 ± 0.746
        Previously took GH treatment: Week 16 (n = 13)
    2.93 ± 0.746
        GH Treatment-naive: Week 29 (n = 59)
    3.36 ± 0.737
        Previously took GH treatment: Week 29 (n = 13)
    3.22 ± 0.903
        GH Treatment-naive: Week 39 (n = 61)
    3.45 ± 0.938
        Previously took GH treatment: Week 39 (n = 14)
    3.03 ± 0.853
        GH Treatment-naive: Week 41 (n= 56)
    2.91 ± 0.758
        Previously took GH treatment: Week 41 (n = 12)
    2.63 ± 0.786
    No statistical analyses for this end point

    Secondary: Insulin-like Growth Factor-I Standard Deviation Score (IGF-I SDS)

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    End point title
    Insulin-like Growth Factor-I Standard Deviation Score (IGF-I SDS)
    End point description
    Insulin-like Growth Factor-1 SDS was calculated based on the actual value of IGF-1 minus reference value of IGF-1 divided by reference standard deviation of IGF-1. SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a subject's value was relative to the mean of the reference population. The scores were centered around zero. Negative score indicated that the IGF-I value was lower compared to the reference population. The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, "n" signifies those subjects who were evaluable for the specified category at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 41
    End point values
    Saizen®
    Number of subjects analysed
    78
    Units: Standard deviation score
    arithmetic mean (standard deviation)
        GH Treatment-naive: Baseline (n = 64)
    -3.27 ± 0.816
        Previously took GH treatment : Baseline (n = 14)
    -3.67 ± 1.223
        GH Treatment-naive: Week 2 (n = 64)
    -3.1 ± 0.775
        Previously took GH treatment: Week 2 (n = 14)
    -3.46 ± 1.14
        GH Treatment-naive: Week 8 (n = 63)
    -3.05 ± 0.769
        Previously took GH treatment: Week 8 (n = 13)
    -3.16 ± 0.697
        GH Treatment-naive: Week 16 (n = 59)
    -3.09 ± 0.799
        Previously took GH treatment: Week 16 (n = 13)
    -3.17 ± 0.652
        GH Treatment-naive: Week 29 (n = 59)
    -3.01 ± 0.773
        Previously took GH treatment: Week 29 (n = 13)
    -3.17 ± 0.713
        GH Treatment-naive: Week 39 (n = 61)
    -3.02 ± 0.78
        Previously took GH treatment: Week 39 (n = 14)
    -3.44 ± 1.29
        GH Treatment-naive: Week 41 (n= 56)
    -3.23 ± 0.83
        Previously took GH treatment: Week 41 (n = 12)
    -3.31 ± 0.69
    No statistical analyses for this end point

    Secondary: Treatment Adherence Rate as Documented Using EasypodTM Connect

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    End point title
    Treatment Adherence Rate as Documented Using EasypodTM Connect
    End point description
    Treatment adherence rate was measured by: (total dose received divided by total dose prescribed) multiplied by 100. Saizen solution for injection was administered using the easypod device and treatment adherence information was obtained from the device using the easypod connect software. The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®.
    End point type
    Secondary
    End point timeframe
    Week 2, 8, 16, 29 and 39
    End point values
    Saizen®
    Number of subjects analysed
    78
    Units: percentage of treatment adherence
        arithmetic mean (standard deviation)
    89.3 ± 13.35
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation

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    End point title
    Number of Subjects With Treatment-emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are those events with onset dates occurring during the on-treatment period or if the worsening of an event is during the on-treatment period. TEAEs include both Serious TEAEs and non-serious TEAEs. The safety analysis set.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 41
    End point values
    Saizen®
    Number of subjects analysed
    78
    Units: subjects
        TEAEs
    72
        Serious TEAEs
    4
        TEAEs Leading to Death
    0
        TEAEs Leading to Discontinuation
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 41
    Adverse event reporting additional description
    Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Saizen®
    Reporting group description
    Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.

    Serious adverse events
    Saizen®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 78 (5.13%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Oesophagitis
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Saizen®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 78 (83.33%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Contusion
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Fall
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Dyspnoea
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Oropharyngeal pain
         subjects affected / exposed
    5 / 78 (6.41%)
         occurrences all number
    5
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    27 / 78 (34.62%)
         occurrences all number
    27
    Lethargy
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Migraine
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Paraesthesia
         subjects affected / exposed
    4 / 78 (5.13%)
         occurrences all number
    4
    General disorders and administration site conditions
    Vomiting
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Chest discomfort
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Injection site bruising
         subjects affected / exposed
    7 / 78 (8.97%)
         occurrences all number
    7
    Injection site pain
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Oedema peripheral
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Peripheral swelling
         subjects affected / exposed
    4 / 78 (5.13%)
         occurrences all number
    4
    Pyrexia
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Vertigo
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    4 / 78 (5.13%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    6 / 78 (7.69%)
         occurrences all number
    6
    Dry mouth
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Haemorrhoids
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    5 / 78 (6.41%)
         occurrences all number
    5
    Toothache
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    7 / 78 (8.97%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Eczema
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Hyperhidrosis
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    13 / 78 (16.67%)
         occurrences all number
    13
    Arthritis
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Back pain
         subjects affected / exposed
    10 / 78 (12.82%)
         occurrences all number
    10
    Joint swelling
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Musculoskeletal pain
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Neck pain
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    4 / 78 (5.13%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Infections and infestations
    Influenza
         subjects affected / exposed
    6 / 78 (7.69%)
         occurrences all number
    6
    Lower respiratory tract infection
         subjects affected / exposed
    5 / 78 (6.41%)
         occurrences all number
    5
    Nasopharyngitis
         subjects affected / exposed
    21 / 78 (26.92%)
         occurrences all number
    21
    Sinusitis
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Tooth abscess
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 78 (7.69%)
         occurrences all number
    6
    Urinary tract infection
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3
    Viral infection
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Oct 2013
    Modified exclusion criterion 3 to allow inclusion of subjects with adequately treated basal cell or squamous cell skin cancer.
    15 Jul 2014
    1) Modified inclusion criterion 5 by increasing the maximum permitted BMI level measured at the Screening visit (Weight in kilograms / [Height in meters]^2 ) from less than or equal to (<=) 35 to <= 40 kg/m^ 2 . 2) Updated administrative information to reflect the change in the Sponsor’s medical responsible, clinical trial leader and the principal statistician.
    09 Oct 2014
    1) Modified inclusion criterion 2 to allow recruitment of subjects with CO-AGHD as well as AO-AGHD. 2) Modified inclusion criterion 3 to allow enrollment of subjects who stopped prior GH treatment for AGHD 1 month prior to Screening as compared to at least 3 months prior to Screening previously. 3) Modified exclusion criterion 3 to ensure that the wording is in alignment with the Saizen label. Provided clarification that the presence of an active malignancy is a contraindication and that any pre-existing malignancy must be inactive with anti-tumor therapy completed prior to starting trial on Saizen therapy. 4) Updated administrative information to reflect the change in the Sponsor’s principal statistician and the central laboratory.

    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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