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    Clinical Trial Results:
    A Study of Long-Term Recombinant Human Insulin-Like Growth Factor-1 (rhIGF-1) Treatment of Children With Short Stature Due to Severe Primary IGF-1 Deficiency

    Summary
    EudraCT number
    		 2025-000222-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Dec 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Dec 2025
    First version publication date
    21 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1419
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00571727
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Biopharmaceuticals Inc
    Sponsor organisation address
    106 Allen Road, 3rd Floor, Basking Ridge, New Jersey, United States, 07920
    Public contact
    Medical Director, Ipsen, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Ipsen, clinical.trials@ipsen.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
    15 Dec 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Dec 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the safety and efficacy of long-term replacement therapy with mecasermin in children with growth failure due to severe primary insulin-like growth factor-1 (IGF-1) deficiency.
    Protection of trial subjects
    The study was conducted in accordance with the ethical and regulatory national or international guidelines and requirements in place at the beginning of the study and updated as appropriate.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 May 1991
    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: 7
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Bahamas: 2
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Egypt: 7
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Iran, Islamic Republic of: 4
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Kuwait: 4
    Country: Number of subjects enrolled
    Pakistan: 1
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    Saudi Arabia: 25
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Syria: 1
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    Ukraine: 1
    Country: Number of subjects enrolled
    United States: 8
    Country: Number of subjects enrolled
    Yemen: 1
    Worldwide total number of subjects
    92
    EEA total number of subjects
    18
    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)
    2
    Children (2-11 years)
    70
    Adolescents (12-17 years)
    20
    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
    		 This Phase 3, open-label study was conducted in children with short stature due to severe primary insulin like growth factor-1 deficiency at 2 investigative sites in the US in conjunction with sites in 23 other countries.

    Pre-assignment
    Screening details
    		 Participants who had been treated with mecasermin in previous Genentech-sponsored studies (F0206s, F0375g, F0632g, F0671g), as well as new participants naïve to mecasermin treatment, were enrolled in this study.

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

    Arms
    Arm title
    		 Mecasermin
    Arm description
    		 Participants who were entered from previous studies continued to receive mecasermin 80 to 120 microgram per kilograms (mcg/kg) subcutaneously (SC) twice daily and naïve-to-treatment participants were administered mecasermin 60 to 80 mcg/kg SC twice daily for 1 to 2 weeks, and then increased to 120 mcg/kg as tolerated.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mecasermin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Mecasermin 80 to 120 mcg/kg SC twice daily was administered for participants who were already treated in previous studies and mecasermin 60 to 80 mcg/kg SC twice daily was administered for participants who were naïve to the treatment. For treatment naïve participants, the dose was administered for 1 to 2 weeks and then increased to 120 mcg/kg.

    Number of subjects in period 1
    		Mecasermin
    Started
    92
    Completed
    26
    Not completed
    66
         Poor growth
    1
         Unable to provide study drug
    6
         Did not enter in this study
    1
         Non-compliance
    4
         On-treatment at end of study
    8
         Parent/patient decision
    2
         Lost to follow-up
    30
         Participant transferred to commercial drug
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mecasermin
    Reporting group description
    		 Participants who were entered from previous studies continued to receive mecasermin 80 to 120 microgram per kilograms (mcg/kg) subcutaneously (SC) twice daily and naïve-to-treatment participants were administered mecasermin 60 to 80 mcg/kg SC twice daily for 1 to 2 weeks, and then increased to 120 mcg/kg as tolerated.

    Reporting group values
    		 Mecasermin Total
    Number of subjects
    		 92 92
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.6 ( 4.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 39 39
        Male
    		 53 53
    Race/Ethnicity
    Units: Subjects
        Caucasian
    		 77 77
        African American
    		 3 3
        Hispanic
    		 6 6
        Asian
    		 4 4
        Other
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Mecasermin
    Reporting group description
    		 Participants who were entered from previous studies continued to receive mecasermin 80 to 120 microgram per kilograms (mcg/kg) subcutaneously (SC) twice daily and naïve-to-treatment participants were administered mecasermin 60 to 80 mcg/kg SC twice daily for 1 to 2 weeks, and then increased to 120 mcg/kg as tolerated.

    Primary: Annualized Height Velocity Up to 12 Years

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    End point title
    		 Annualized Height Velocity Up to 12 Years [1]
    End point description
    Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements. The intention-to-treat population consisted of all 92 participants. Only data from the participants naïve to exogenous recombinant human insulin-like growth factor-1 (rhIGF-1) and whose pre-treatment height velocity were available were reported. Here, n= number of participants analyzed at specific timepoint.
    End point type
    Primary
    End point timeframe
    Baseline (Pre-dose) and up to 12 years
    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 statistical analysis was performed for the primary endpoint.
    End point values
    		 Mecasermin
    Number of subjects analysed
    75
    Units: centimeter per year (cm/y)
    arithmetic mean (standard deviation)
        Baseline (Pre-dose) (n=75)
    2.6 ( 1.7 )
        >= 1 year (n=75)
    8.0 ( 2.3 )
        >= 2 years (n=63)
    5.9 ( 1.7 )
        >= 3 years (n=62)
    5.5 ( 1.8 )
        >= 4 years (n=60)
    5.2 ( 1.5 )
        >= 5 years (n=53)
    4.9 ( 1.5 )
        >= 6 years (n=39)
    4.8 ( 1.4 )
        >= 7 years (n=25)
    4.3 ( 1.5 )
        >= 8 years (n=19)
    4.4 ( 1.5 )
        >= 9 years (n=14)
    4.4 ( 1.7 )
        >= 10 years (n=13)
    4.5 ( 2.0 )
        >= 11 years (n=12)
    4.1 ( 2.0 )
        >= 12 years (n=10)
    3.9 ( 2.0 )
    No statistical analyses for this end point

    Primary: Number of Naive Participants With Height Velocity <5 cm/y at the End of 1 Year of Study Treatment

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    End point title
    		 Number of Naive Participants With Height Velocity <5 cm/y at the End of 1 Year of Study Treatment [2]
    End point description
    Height measurements were performed using wall-mounted stadiometers for analysis of growth data. The intention-to-treat population consisted of all 92 participants. Only data from the participants naïve to exogenous rhIGF-1 were reported.
    End point type
    Primary
    End point timeframe
    Baseline (Pre-dose) and 1 year
    Notes
    [2] - 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 statistical analysis was performed for the primary endpoint.
    End point values
    		 Mecasermin
    Number of subjects analysed
    81
    Units: participants
    7
    No statistical analyses for this end point

    Secondary: Height Velocity Standard Deviation Score Up to 12 Years

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    End point title
    		 Height Velocity Standard Deviation Score Up to 12 Years
    End point description
    Center for disease control growth charts from the US were used as reference for age and gender-dependent mean and standard deviation. Height velocity-standard deviation score was calculated as height velocity minus reference mean height velocity divided by standard deviation of the reference mean height velocity. Greater height velocity standard deviation score indicates better outcome. The intention-to-treat population consisted of all 92 participants. Only data from the participants naïve to exogenous rhIGF-1 and whose pre-treatment height velocity were available were reported. Here, n= number of participants analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose) and up to 12 years
    End point values
    		 Mecasermin
    Number of subjects analysed
    75
    Units: standard deviation score
    arithmetic mean (standard deviation)
        Baseline (Pre-dose) (n=75)
    -3.4 ( 1.6 )
        >= 1 year (n=75)
    1.7 ( 2.8 )
        >= 2 years (n=62)
    -0.0 ( 1.7 )
        >= 3 years (n=61)
    -0.1 ( 1.9 )
        >= 4 years (n=58)
    -0.2 ( 1.9 )
        >= 5 years (n=50)
    -0.3 ( 1.7 )
        >= 6 years (n=37)
    -0.2 ( 1.6 )
        >= 7 years (n=22)
    -0.5 ( 1.7 )
        >= 8 years (n=15)
    -0.2 ( 1.6 )
        >= 9 years (n=12)
    -0.4 ( 0.8 )
        >= 10 years (n=11)
    0.1 ( 1.6 )
        >= 11 years (n=11)
    0.5 ( 2.6 )
        >= 12 years (n=8)
    -0.1 ( 1.5 )
    No statistical analyses for this end point

    Secondary: Height Standard Deviation Score Up to 12 Years

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    End point title
    		 Height Standard Deviation Score Up to 12 Years
    End point description
    Center for disease control growth charts from the US were used as reference for age and gender-dependent mean and standard deviation. Height standard deviation score was calculated as height minus reference mean height divided by standard deviation of the reference mean height. A higher height standard deviation score indicates a better outcome. The intention-to-treat population consisted of all 92 participants. Only data from the participants naïve to exogenous rhIGF-1 were reported. Here, n= number of participants analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose) and up to 12 years
    End point values
    		 Mecasermin
    Number of subjects analysed
    81
    Units: standard deviation score
    arithmetic mean (standard deviation)
        Baseline (Pre-dose) (n=81)
    -6.9 ( 1.8 )
        >= 1 year (n=81)
    -6.1 ( 1.8 )
        >= 2 years (n=67)
    -5.6 ( 1.7 )
        >= 3 years (n=66)
    -5.3 ( 1.7 )
        >= 4 years (n=64)
    -5.1 ( 1.7 )
        >= 5 years (n=57)
    -5.0 ( 1.7 )
        >= 6 years (n=41)
    -4.9 ( 1.6 )
        >= 7 years (n=26)
    -4.9 ( 1.7 )
        >= 8 years (n=19)
    -5.1 ( 1.7 )
        >= 9 years (n=14)
    -5.0 ( 1.6 )
        >= 10 years (n=13)
    -5.0 ( 1.7 )
        >= 11 years (n=12)
    -4.7 ( 1.2 )
        >= 12 years (n=10)
    -4.4 ( 1.3 )
    No statistical analyses for this end point

    Secondary: Approximate Increase in Height Over Expected for Naïve Participants With Near-Adult Height

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    End point title
    		 Approximate Increase in Height Over Expected for Naïve Participants With Near-Adult Height
    End point description
    Height measurements were performed using wall-mounted stadiometers for analysis of growth data. The intention-to-treat population consisted of all 92 participants. Only data from the participants naïve to exogenous rhIGF-1 and who attained near adult height were reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose) and up to 19 years
    End point values
    		 Mecasermin
    Number of subjects analysed
    21
    Units: cm
        arithmetic mean (standard deviation)
    13.3 ( 8.4 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events were collected from first date of mecasermin intake until last dose, approximately 19 years
    Adverse event reporting additional description
    The safety population consisted of all participants who had received at least 1 dose of mecasermin treatment. Adverse events were not collected per dose level as pre-specified.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Mecasermin
    Reporting group description
    		 Participants who were entered from previous studies continued to receive mecasermin 80 to 120 mcg/kg SC twice daily and naïve-to-treatment participants were administered mecasermin 60 to 80 mcg/kg SC twice daily for 1 to 2 weeks, and then increased to 120 mcg/kg as tolerated.

    Serious adverse events
    		 Mecasermin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 92 (19.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Dilatation ventricular
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Benign intracranial hypertension
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Haematemesis
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tonsillar hypertrophy
         subjects affected / exposed
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Adenoidal hypertrophy
         subjects affected / exposed
    3 / 92 (3.26%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Epiphysiolysis
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infectious pleural effusion
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemic seizure
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Mecasermin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    73 / 92 (79.35%)
    Surgical and medical procedures
    Ear tube insertion
         subjects affected / exposed
    7 / 92 (7.61%)
         occurrences all number
    11
    Dental operation
         subjects affected / exposed
    6 / 92 (6.52%)
         occurrences all number
    6
    General disorders and administration site conditions
    Injection site hypertrophy
         subjects affected / exposed
    32 / 92 (34.78%)
         occurrences all number
    211
    Pyrexia
         subjects affected / exposed
    19 / 92 (20.65%)
         occurrences all number
    77
    Fatigue
         subjects affected / exposed
    9 / 92 (9.78%)
         occurrences all number
    16
    Injection site haematoma
         subjects affected / exposed
    9 / 92 (9.78%)
         occurrences all number
    22
    Hypertrophy
         subjects affected / exposed
    8 / 92 (8.70%)
         occurrences all number
    52
    Asthenia
         subjects affected / exposed
    5 / 92 (5.43%)
         occurrences all number
    7
    Chest pain
         subjects affected / exposed
    5 / 92 (5.43%)
         occurrences all number
    10
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    6 / 92 (6.52%)
         occurrences all number
    18
    Respiratory, thoracic and mediastinal disorders
    Snoring
         subjects affected / exposed
    20 / 92 (21.74%)
         occurrences all number
    111
    Tonsillar hypertrophy
         subjects affected / exposed
    19 / 92 (20.65%)
         occurrences all number
    102
    Cough
         subjects affected / exposed
    16 / 92 (17.39%)
         occurrences all number
    48
    Adenoidal hypertrophy
         subjects affected / exposed
    7 / 92 (7.61%)
         occurrences all number
    12
    Nasal congestion
         subjects affected / exposed
    9 / 92 (9.78%)
         occurrences all number
    37
    Investigations
    Cardiac murmur
         subjects affected / exposed
    7 / 92 (7.61%)
         occurrences all number
    10
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    6 / 92 (6.52%)
         occurrences all number
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    25 / 92 (27.17%)
         occurrences all number
    109
    Dizziness
         subjects affected / exposed
    6 / 92 (6.52%)
         occurrences all number
    9
    Blood and lymphatic system disorders
    Thymus enlargement
         subjects affected / exposed
    9 / 92 (9.78%)
         occurrences all number
    24
    Lymphadenopathy
         subjects affected / exposed
    5 / 92 (5.43%)
         occurrences all number
    9
    Ear and labyrinth disorders
    Conductive deafness
         subjects affected / exposed
    11 / 92 (11.96%)
         occurrences all number
    70
    Middle ear effusion
         subjects affected / exposed
    10 / 92 (10.87%)
         occurrences all number
    21
    Deafness
         subjects affected / exposed
    6 / 92 (6.52%)
         occurrences all number
    50
    Ear pain
         subjects affected / exposed
    6 / 92 (6.52%)
         occurrences all number
    9
    Ear discomfort
         subjects affected / exposed
    5 / 92 (5.43%)
         occurrences all number
    27
    Eye disorders
    Papilloedema
         subjects affected / exposed
    5 / 92 (5.43%)
         occurrences all number
    7
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    16 / 92 (17.39%)
         occurrences all number
    28
    Dental caries
         subjects affected / exposed
    11 / 92 (11.96%)
         occurrences all number
    45
    Abdominal pain
         subjects affected / exposed
    7 / 92 (7.61%)
         occurrences all number
    13
    Constipation
         subjects affected / exposed
    6 / 92 (6.52%)
         occurrences all number
    10
    Diarrhoea
         subjects affected / exposed
    6 / 92 (6.52%)
         occurrences all number
    14
    Abdominal pain upper
         subjects affected / exposed
    5 / 92 (5.43%)
         occurrences all number
    6
    Tooth crowding
         subjects affected / exposed
    5 / 92 (5.43%)
         occurrences all number
    24
    Toothache
         subjects affected / exposed
    5 / 92 (5.43%)
         occurrences all number
    11
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    10 / 92 (10.87%)
         occurrences all number
    26
    Dry skin
         subjects affected / exposed
    10 / 92 (10.87%)
         occurrences all number
    31
    Skin hypertrophy
         subjects affected / exposed
    10 / 92 (10.87%)
         occurrences all number
    36
    Rash
         subjects affected / exposed
    6 / 92 (6.52%)
         occurrences all number
    9
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 92 (8.70%)
         occurrences all number
    24
    Pain in extremity
         subjects affected / exposed
    8 / 92 (8.70%)
         occurrences all number
    25
    Back pain
         subjects affected / exposed
    7 / 92 (7.61%)
         occurrences all number
    18
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    23 / 92 (25.00%)
         occurrences all number
    73
    Otitis media
         subjects affected / exposed
    19 / 92 (20.65%)
         occurrences all number
    76
    Nasopharyngitis
         subjects affected / exposed
    14 / 92 (15.22%)
         occurrences all number
    36
    Influenza
         subjects affected / exposed
    12 / 92 (13.04%)
         occurrences all number
    17
    Bronchitis
         subjects affected / exposed
    7 / 92 (7.61%)
         occurrences all number
    8
    Ear infection
         subjects affected / exposed
    7 / 92 (7.61%)
         occurrences all number
    19
    Gastroenteritis
         subjects affected / exposed
    7 / 92 (7.61%)
         occurrences all number
    9
    Pharyngitis
         subjects affected / exposed
    7 / 92 (7.61%)
         occurrences all number
    16
    Respiratory tract infection
         subjects affected / exposed
    6 / 92 (6.52%)
         occurrences all number
    7
    Tonsillitis
         subjects affected / exposed
    6 / 92 (6.52%)
         occurrences all number
    8
    Varicella
         subjects affected / exposed
    5 / 92 (5.43%)
         occurrences all number
    5
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    41 / 92 (44.57%)
         occurrences all number
    175
    Hypoglycaemic seizure
         subjects affected / exposed
    5 / 92 (5.43%)
         occurrences all number
    13

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Apr 2007
    Amended to update mecasermin dose of up to 160 mcg/kg SC twice daily was used in some pubertal participants.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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