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    Clinical Trial Results:
    A 12-Week Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects Aged 1 Year through 17 Years, with Short Bowel Syndrome who are Dependent on Parenteral Support

    Summary
    EudraCT number
    		 2013-004588-30
    Trial protocol
    		 SE   GB  
    Global end of trial date
    09 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Apr 2016
    First version publication date
    28 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TED-C13-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01952080
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NPS Pharmaceuticals, Inc. (Since 21 February 2015, NPS Pharmaceuticals, Inc. has been a member of the Shire Group of companies)
    Sponsor organisation address
    300 Shire Way, Lexington, United States, 02421
    Public contact
    Shire Development LLC, Study Physician , +1 8668425335,
    Scientific contact
    Shire Development LLC, Study Physician, +1 8668425335,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000482-PIP01-08
    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
    09 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this clinical study was to evaluate the pharmacokinetic (PK) profile, safety and tolerability, and pharmacodynamic effects of teduglutide compared with standard of care in pediatric subjects (aged 1 year through 17 years) with short bowel syndrome (SBS) who are dependent on parenteral support.
    Protection of trial subjects
    This protocol was conducted in accordance with the current applicable International Conference on Harmonisation (ICH) Guidelines, Good Clinical Practice, and the World Medical Association Declaration of Helsinki and its amendments concerning medical research in humans at the time of the study was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Nov 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 39
    Worldwide total number of subjects
    42
    EEA total number of subjects
    3
    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)
    4
    Children (2-11 years)
    35
    Adolescents (12-17 years)
    3
    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
    		 Subjects were recruited to participate at 17 sites in 2 countries (United Kingdom and United States of America)

    Pre-assignment
    Screening details
    		 Subjects were screened for eligibility for a minimum of 2 weeks.

    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
    Yes

    Arm title
    		 Standard of care
    Arm description
    		 Subjects received the standard of care
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Teduglutide 0.0125 mg/kg/Day
    Arm description
    		 Cohort 1 - Teduglutide 0.0125 mg/kg/Day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Teduglutide
    Investigational medicinal product code
    Other name
    ALX-0600, Gattex, Revestive
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received teduglutide 0.0125 mg/kg/day of a 10 mg/mL, 5 mg/mL, or 2.5 mg/mL solution in the morning for 12 weeks. The dose calculation was based on body weight measured at the Baseline Visit (Visit 2). No adjustments to dose were made during the study period. Teduglutide was administered by subcutaneous injection into 1 of the 4 quadrants of the abdomen (in subjects without a stoma) or either thigh or arm.

    Arm title
    		 Teduglutide 0.025 mg/kg/Day
    Arm description
    		 Cohort 2 -Teduglutide 0.025mg/kg/Day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Teduglutide
    Investigational medicinal product code
    Other name
    ALX-0600, Gattex, Revestive
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received teduglutide 0.025 mg/kg/day of a 10 mg/mL, 5 mg/mL, or 2.5 mg/mL solution in the morning for 12 weeks. The dose calculation was based on body weight measured at the Baseline Visit (Visit 2). No adjustments to dose were made during the study period. Teduglutide was administered by subcutaneous injection into 1 of the 4 quadrants of the abdomen (in subjects without a stoma) or either thigh or arm.

    Arm title
    		 Teduglutide 0.05 mg/kg/Day
    Arm description
    		 Cohort 3 - Teduglutide 0.05 mg/kg/Day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Teduglutide
    Investigational medicinal product code
    Other name
    ALX-0600, Gattex, Revestive
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received teduglutide 0.05 mg/kg/day of a 10 mg/mL, 5 mg/mL, or 2.5 mg/mL solution in the morning for 12 weeks. The dose calculation was based on body weight measured at the Baseline Visit (Visit 2). No adjustments to dose were made during the study period. Teduglutide was administered by subcutaneous injection into 1 of the 4 quadrants of the abdomen (in subjects without a stoma) or either thigh or arm.

    Number of subjects in period 1
    		Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Started
    5
    8
    14
    15
    Completed
    5
    7
    14
    14
    Not completed
    0
    1
    0
    1
         Protocol non-compliance
    -
    1
    -
    -
         Withdrawal by subject
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard of care
    Reporting group description
    		 Subjects received the standard of care

    Reporting group title
    Teduglutide 0.0125 mg/kg/Day
    Reporting group description
    		 Cohort 1 - Teduglutide 0.0125 mg/kg/Day

    Reporting group title
    Teduglutide 0.025 mg/kg/Day
    Reporting group description
    		 Cohort 2 -Teduglutide 0.025mg/kg/Day

    Reporting group title
    Teduglutide 0.05 mg/kg/Day
    Reporting group description
    		 Cohort 3 - Teduglutide 0.05 mg/kg/Day

    Reporting group values
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day Total
    Number of subjects
    		 5 8 14 15 42
    Age categorical
    Units: Subjects
        1 to 3 years
    		 5 4 6 7 22
        4 to 12 years
    		 0 3 7 7 17
        13 to 17 years
    		 0 1 1 1 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 2.2 ± 0.45 5.1 ± 4.55 4.6 ± 3.43 4.5 ± 3.16 -
    Gender categorical
    Units: Subjects
        Female
    		 2 2 3 7 14
        Male
    		 3 6 11 8 28
    Region of enrollment
    Units: Subjects
        United States
    		 5 8 14 12 39
        United Kingdom
    		 0 0 0 3 3

    End points

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    End points reporting groups
    Reporting group title
    Standard of care
    Reporting group description
    		 Subjects received the standard of care

    Reporting group title
    Teduglutide 0.0125 mg/kg/Day
    Reporting group description
    		 Cohort 1 - Teduglutide 0.0125 mg/kg/Day

    Reporting group title
    Teduglutide 0.025 mg/kg/Day
    Reporting group description
    		 Cohort 2 -Teduglutide 0.025mg/kg/Day

    Reporting group title
    Teduglutide 0.05 mg/kg/Day
    Reporting group description
    		 Cohort 3 - Teduglutide 0.05 mg/kg/Day

    Primary: Percent Change in Parenteral Support (Parenteral Nutrition [PN]/Intravenous [IV]) Volume at Week 12

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    End point title
    		 Percent Change in Parenteral Support (Parenteral Nutrition [PN]/Intravenous [IV]) Volume at Week 12 [1]
    End point description
    Percent change in PN/IV from the Baseline Visit to Week 12 Visit. Percent change in PN/IV volume from baseline to Visit timepoints based on prescribed data - Intent-to-Treat Population, defined as subjects who were enrolled in the study.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    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: The small sample size resulting from the small study population required the use of descriptive statistics with a goal of summarizing the sample.
    End point values
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Number of subjects analysed
    5
    7
    13
    14
    Units: percent change
        arithmetic mean (standard deviation)
    7.38 ± 12.756
    -9.95 ± 21.625
    -37.34 ± 26.422
    -39.11 ± 40.792
    No statistical analyses for this end point

    Primary: Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment

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    End point title
    		 Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment [2]
    End point description
    Percent change in PN/IV from the Baseline Visit to End of Treatment Visit. Percent change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population.
    End point type
    Primary
    End point timeframe
    Baseline, End of Treatment
    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: The small sample size resulting from the small study population required the use of descriptive statistics with a goal of summarizing the sample.
    End point values
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Number of subjects analysed
    5
    8
    14
    15
    Units: percent change
        arithmetic mean (standard deviation)
    7.38 ± 12.756
    -8.6 ± 20.38
    -35.61 ± 26.198
    -36.5 ± 40.585
    No statistical analyses for this end point

    Primary: Percent Change in Parenteral Support (PN/IV) Volume at Week 16

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    End point title
    		 Percent Change in Parenteral Support (PN/IV) Volume at Week 16 [3]
    End point description
    Percent change in PN/IV from the Baseline Visit to Week 16 Visit. Percent change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    Notes
    [3] - 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: The small sample size resulting from the small study population required the use of descriptive statistics with a goal of summarizing the sample.
    End point values
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Number of subjects analysed
    5
    7
    14
    14
    Units: percent change
        arithmetic mean (standard deviation)
    3.92 ± 16.616
    -11.25 ± 21.196
    -33.85 ± 27.017
    -31.8 ± 39.264
    No statistical analyses for this end point

    Primary: Absolute Change in Parenteral Support (PN/IV) Volume at Week 12

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    End point title
    		 Absolute Change in Parenteral Support (PN/IV) Volume at Week 12 [4]
    End point description
    Absolute change in PN/IV from the Baseline Visit to Week 12 Visit. Absolute change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    Notes
    [4] - 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: The small sample size resulting from the small study population required the use of descriptive statistics with a goal of summarizing the sample.
    End point values
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Number of subjects analysed
    5
    7
    13
    14
    Units: Litres/week
        arithmetic mean (standard deviation)
    0.43 ± 0.746
    -0.5 ± 0.91
    -2.78 ± 1.985
    -2.57 ± 3.564
    No statistical analyses for this end point

    Primary: Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment

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    End point title
    		 Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment [5]
    End point description
    Absolute change in PN/IV from the Baseline Visit to End of Treatment Visit. Absolute change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population.
    End point type
    Primary
    End point timeframe
    Baseline, End of Treatment
    Notes
    [5] - 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: The small sample size resulting from the small study population required the use of descriptive statistics with a goal of summarizing the sample.
    End point values
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Number of subjects analysed
    5
    8
    14
    15
    Units: Litres/week
        arithmetic mean (standard deviation)
    0.43 ± 0.746
    -0.43 ± 0.864
    -2.73 ± 1.916
    -2.4 ± 3.498
    No statistical analyses for this end point

    Primary: Absolute Change in Parenteral Support (PN/IV) Volume at Week 16

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    End point title
    		 Absolute Change in Parenteral Support (PN/IV) Volume at Week 16 [6]
    End point description
    Absolute change in PN/IV from the Baseline Visit to Week 16 Visit. Absolute change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    Notes
    [6] - 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: The small sample size resulting from the small study population required the use of descriptive statistics with a goal of summarizing the sample.
    End point values
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Number of subjects analysed
    5
    7
    14
    14
    Units: Litres/week
        arithmetic mean (standard deviation)
    0.17 ± 1.027
    -0.56 ± 0.885
    -2.56 ± 1.917
    -1.99 ± 3.092
    No statistical analyses for this end point

    Other pre-specified: Percent Change in Enteral Support (EN) Volume From Baseline at Week 12

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    End point title
    		 Percent Change in Enteral Support (EN) Volume From Baseline at Week 12
    End point description
    Percent change in enteral support requirements at Week 12 (litres/week). Percent change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12
    End point values
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Number of subjects analysed
    3
    4
    12
    8
    Units: percent change
        arithmetic mean (standard deviation)
    16.82 ± 14.921
    23.5 ± 22.06
    50.93 ± 61.416
    57.96 ± 44.953
    No statistical analyses for this end point

    Other pre-specified: Percent Change in Enteral Support (EN) Volume From Baseline at Week 16

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    End point title
    		 Percent Change in Enteral Support (EN) Volume From Baseline at Week 16
    End point description
    Percent change in enteral support requirements at Week 16 (litres/week). Percent change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population. "99999" indicates that no standard deviation (SD) is presented when only one subject had data for this time point.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 16
    End point values
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Number of subjects analysed
    4
    1
    11
    9
    Units: percent change
        arithmetic mean (standard deviation)
    52.06 ± 66.194
    60.3 ± 99999
    43.98 ± 78.599
    58.93 ± 63.927
    No statistical analyses for this end point

    Other pre-specified: Absolute Change in Enteral Support (EN) Volume From Baseline at Week 12

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    End point title
    		 Absolute Change in Enteral Support (EN) Volume From Baseline at Week 12
    End point description
    Absolute change in enteral support requirements at Week 12 (litres/week). Absolute change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12
    End point values
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Number of subjects analysed
    4
    7
    12
    12
    Units: Litres/week
        arithmetic mean (standard deviation)
    0.69 ± 0.715
    2.67 ± 4.412
    2.64 ± 3.22
    0.97 ± 1.127
    No statistical analyses for this end point

    Other pre-specified: Absolute Change in Enteral Support (EN) Volume From Baseline at Week 16

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    End point title
    		 Absolute Change in Enteral Support (EN) Volume From Baseline at Week 16
    End point description
    Absolute change in enteral support requirements at Week 16 (litres/week). Absolute change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 16
    End point values
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Number of subjects analysed
    5
    3
    11
    13
    Units: Litres/week
        arithmetic mean (standard deviation)
    0.84 ± 0.624
    4.56 ± 5.384
    2.47 ± 3.403
    0.91 ± 0.968
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from the first patient consent to the time of the last visit for a duration of 421 days.
    Adverse event reporting additional description
    This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Standard of care
    Reporting group description
    		 Subjects received the standard of care

    Reporting group title
    Teduglutide 0.0125 mg/kg/Day
    Reporting group description
    		 Cohort 1 - Teduglutide 0.0125 mg/kg/Day

    Reporting group title
    Teduglutide 0.025 mg/kg/Day
    Reporting group description
    		 Cohort 2 -Teduglutide 0.025mg/kg/Day

    Reporting group title
    Teduglutide 0.05 mg/kg/Day
    Reporting group description
    		 Cohort 3 - Teduglutide 0.05 mg/kg/Day

    Serious adverse events
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    3 / 8 (37.50%)
    6 / 14 (42.86%)
    8 / 15 (53.33%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Depressed level of consciousness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    3 / 15 (20.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter related complication
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    2 / 14 (14.29%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritability
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequent bowel movements
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Central line infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    3 / 14 (21.43%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter related infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter sepsis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fungaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Standard of care Teduglutide 0.0125 mg/kg/Day Teduglutide 0.025 mg/kg/Day Teduglutide 0.05 mg/kg/Day
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    8 / 8 (100.00%)
    14 / 14 (100.00%)
    15 / 15 (100.00%)
    Vascular disorders
    Pallor
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    General disorders and administration site conditions
    Catheter related complication
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 8 (37.50%)
    4 / 14 (28.57%)
    2 / 15 (13.33%)
         occurrences all number
    1
    4
    4
    3
    Fatigue
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    4 / 15 (26.67%)
         occurrences all number
    0
    0
    1
    11
    Injection site haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    0
    0
    0
    4
    Pyrexia
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 8 (0.00%)
    2 / 14 (14.29%)
    7 / 15 (46.67%)
         occurrences all number
    3
    0
    2
    8
    Irritability
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    2 / 14 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 8 (12.50%)
    2 / 14 (14.29%)
    4 / 15 (26.67%)
         occurrences all number
    1
    3
    3
    5
    Rhinorrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    1
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    2 / 14 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    1
    Bacteria urine
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    1
    0
    0
    2
    Blood bicarbonate decreased
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 8 (12.50%)
    1 / 14 (7.14%)
    3 / 15 (20.00%)
         occurrences all number
    2
    1
    1
    4
    Blood urine present
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    2
    Protein urine present
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    2
    Red blood cells urine positive
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    2
    Weight decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    1
    White blood cells urine positive
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    2
    C-reactive protein increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    Urine leukocyte esterase positive
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    White blood cell count increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Feeding tube complication
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    2 / 14 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Gastrointestinal stoma complication
    Additional description: Only 1 subject in each of the 3 dosing cohorts had a stoma and no standard of care subject had a stoma.
         subjects affected / exposed [1]
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    5
    Incision site erythema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    1
    3
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    2 / 14 (14.29%)
    2 / 15 (13.33%)
         occurrences all number
    0
    5
    2
    10
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    2 / 14 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    2 / 14 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Eye disorders
    Eyes sunken
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    1
    2
    Abdominal pain
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 8 (12.50%)
    1 / 14 (7.14%)
    4 / 15 (26.67%)
         occurrences all number
    1
    1
    5
    15
    Constipation
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    2
    0
    0
    2
    Diarrhoea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    3 / 15 (20.00%)
         occurrences all number
    1
    0
    1
    6
    Faecal volume increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences all number
    0
    1
    1
    2
    Haematochezia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 8 (25.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    2 / 14 (14.29%)
    2 / 15 (13.33%)
         occurrences all number
    0
    3
    2
    8
    Painful defication
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    2
    Retching
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    2 / 14 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Vomiting
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    5 / 14 (35.71%)
    7 / 15 (46.67%)
         occurrences all number
    0
    0
    8
    29
    Flatulence
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 8 (25.00%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    1
    Rash
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    3
    3
    Rash erythematous
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    0
    1
    Infections and infestations
    Central line infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    3 / 14 (21.43%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    5
    2
    Gastroenteritis viral
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    1
    1
    0
    2
    Influenza
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 8 (25.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    0
    1
    Overgrowth bacterial
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 8 (25.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    1
    Rhinovirus infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    2 / 14 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 5 (40.00%)
    2 / 8 (25.00%)
    4 / 14 (28.57%)
    4 / 15 (26.67%)
         occurrences all number
    2
    3
    6
    4
    Gastrointestinal bacterial infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    Fungaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    2
    Dehydration
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 8 (12.50%)
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only 1 subject in each of the 3 dosing cohorts had a stoma and no standard of care subject had a stoma.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jul 2014
    The following substantial changes were made for implementation at all study sites: 1) Inclusion Criterion 5 was clarified to provide further specific definition of stable PN/IV support. 2) Exclusion Criterion 17 was clarified to provide further details regarding prestudy hospital admissions. 3) The details surrounding the storage conditions of the study medication were clarified. 4) Details for dose interruption of individual subjects and study termination were included in the protocol. 5) Changes from local Amendments 1 and 2 were incorporated for all sites. Local Amendment 1: 1) The observation time after the first SC injection was increased to 4 hours to allow for monitoring of hypersensitivity reactions. 2) The definition of true abstinence was added for females of child bearing potential in order to clarify study requirements. Local Amendment 2: 1) A rationale for the study design was added to provide risk/benefit information for PN/IV support in relation to the protocol design. 2) Additional safety visits were added after EOT and before End of Study for 3 consecutive weeks to provide follow-up safety monitoring. 3) Post-treatment guidance was added to ensure that subjects were returned to their previous standard of care. 4) The time frame of 5 years was added to Exclusion Criterion 8 for history of cancer or clinically significant lymphoproliferative disease. 5) The duration of record retention was extended to 10 years.

    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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