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    Clinical Trial Results:
    A Phase 2b, Randomized, Multicenter, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients With Enteral Feeding Intolerance

    Summary
    EudraCT number
    		 2017-003206-41
    Trial protocol
    		 GB  
    Global end of trial date
    29 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Sep 2020
    First version publication date
    30 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TAK-954-2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03477903
    WHO universal trial number (UTN)
    		 U1111-1208-1831
    Other trial identifiers
    		 18/NE/0139: NRES
    Sponsors
    Sponsor organisation name
    Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company, Ltd.
    Sponsor organisation address
    35 Landsdowne St., Cambridge, United States, 02139
    Public contact
    Study Manager, Takeda Development Centre Europe Ltd., + 44 1256 894003,
    Scientific contact
    Study Manager, Takeda Development Centre Europe Ltd., + 44 1256 894003,
    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
    29 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the treatment effect of intravenous TAK-954 in improving the average daily protein adequacy received through enteral nutrition in critically-ill participants developing EFI. Due to the constraints/requirements of the EudraCT database and concern for participant data privacy, zero subjects are being listed in the below fields.
    Protection of trial subjects
    The informed consent form, subject authorization form and subject information sheet (if applicable) describe the planned and permitted uses, transfers, and disclosures of the subject’s personal health information for purposes of conducting the study. The informed consent form and the subject information sheet (if applicable) further explain the nature of the study, its objectives, and potential risks and benefits, as well as the date informed consent is given.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Aug 2018
    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 States: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    0
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 participants. Due to the constraints/requirements of the EudraCT database and concern for participant data privacy, zero subjects are being listed in the below fields.

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Arm title
    		 Overall
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    TAK-954
    Investigational medicinal product code
    TAK-954
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.1 milligram (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliter (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.

    Number of subjects in period 1
    		Overall
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 99999 99999
    Age Categorical
    Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 99999 99999
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) -
    Gender Categorical
    Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Primary: Average Daily Protein Adequacy Over the First 5 Days of Treatment

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    End point title
    		 Average Daily Protein Adequacy Over the First 5 Days of Treatment [1]
    End point description
    Average daily protein adequacy received through enteral nutrition is defined as the percentage of goal protein delivered per day, where percentage of goal protein delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 5 days was averaged. No data displayed because Endpoint has zero total participants analyzed.
    End point type
    Primary
    End point timeframe
    Days 1 to 5
    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: Not applicable
    End point values
    		 Overall
    Number of subjects analysed
    0 [2]
    Units: number
    Notes
    [2] - Due to low number of participants enrolled at only 1 site, 0 reported due to risk of identification.
    No statistical analyses for this end point

    Secondary: Average Daily Protein Adequacy Over the Study Treatment Period

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    End point title
    		 Average Daily Protein Adequacy Over the Study Treatment Period
    End point description
    Average daily protein adequacy received through enteral nutrition is defined as percentage of goal protein delivered per day, where percentage of protein goal delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 14 days was averaged. No data displayed because Endpoint has zero total participants analyzed.
    End point type
    Secondary
    End point timeframe
    Days 1 to 14
    End point values
    		 Overall
    Number of subjects analysed
    0 [3]
    Units: number
    Notes
    [3] - Due to low number of participants enrolled at only 1 site, 0 reported due to risk of identification.
    No statistical analyses for this end point

    Secondary: Average Daily Change in 24-hour Gastric Residual Volume (GRV) Over the First 5 Days of Study Treatment

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    End point title
    		 Average Daily Change in 24-hour Gastric Residual Volume (GRV) Over the First 5 Days of Study Treatment
    End point description
    GRV is defined as the volume of fluid remaining in the stomach at a point in time during enteral nutrition feeding. The value for each of the 5 days was averaged. No data displayed because Endpoint has zero total participants analyzed.
    End point type
    Secondary
    End point timeframe
    Days 1 to 5
    End point values
    		 Overall
    Number of subjects analysed
    0 [4]
    Units: number
    Notes
    [4] - Due to low number of participants enrolled at only 1 site, 0 reported due to risk of identification.
    No statistical analyses for this end point

    Secondary: Average Daily Caloric Adequacy

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    End point title
    		 Average Daily Caloric Adequacy
    End point description
    Average daily caloric adequacy received through enteral nutrition was defined by percentage of goal calories achieved per day (percentage calorie goal achieved=actual calorie achievement/total participant-specific target calories). The values in the 5-day period and the 14-day period were averaged. No data displayed because Endpoint has zero total participants analyzed.
    End point type
    Secondary
    End point timeframe
    Days 1 to 5 and Days 1 to 14
    End point values
    		 Overall
    Number of subjects analysed
    0 [5]
    Units: number
    Notes
    [5] - Due to low number of participants enrolled at only 1 site, 0 reported due to risk of identification.
    No statistical analyses for this end point

    Secondary: Time to Resolution of Enteral Feeding Intolerance (EFI)

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    End point title
    		 Time to Resolution of Enteral Feeding Intolerance (EFI)
    End point description
    Time to resolution of EFI is defined as the time needed to achieve GRV less than or equal to 250 ml in the absence of vomiting/retching. No data displayed because Endpoint has zero total participants analyzed.
    End point type
    Secondary
    End point timeframe
    Days 1 to 14 or until resolution of EFI, whichever occurs first
    End point values
    		 Overall
    Number of subjects analysed
    0 [6]
    Units: number
    Notes
    [6] - Due to low number of participants enrolled at only 1 site, 0 reported due to risk of identification.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving at Least 80% of Daily Goal Calories

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    End point title
    		 Percentage of Participants Achieving at Least 80% of Daily Goal Calories
    End point description
    No data displayed because Outcome Measure has zero total participants analyzed.
    End point type
    Secondary
    End point timeframe
    Days 1 to 14 or end of treatment
    End point values
    		 Overall
    Number of subjects analysed
    0 [7]
    Units: number
    Notes
    [7] - Due to low number of participants enrolled at only 1 site, 0 reported due to risk of identification.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving at Least 80% of Daily Goal Protein

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    End point title
    		 Percentage of Participants Achieving at Least 80% of Daily Goal Protein
    End point description
    No data displayed because Outcome Measure has zero total participants analyzed.
    End point type
    Secondary
    End point timeframe
    Days 1 to 14 or end of treatment
    End point values
    		 Overall
    Number of subjects analysed
    0 [8]
    Units: number
    Notes
    [8] - Due to low number of participants enrolled at only 1 site, 0 reported due to risk of identification.
    No statistical analyses for this end point

    Secondary: Ctrough: Observed Concentration at the End of a Dosing Interval of TAK-954

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    End point title
    		 Ctrough: Observed Concentration at the End of a Dosing Interval of TAK-954
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5 pre-dose
    End point values
    		 Overall
    Number of subjects analysed
    0 [9]
    Units: number
    Notes
    [9] - Due to low number of participants enrolled at only 1 site, 0 reported due to risk of identification.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 4 days
    Adverse event reporting additional description
    At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the subject or observed by the investigator was recorded, irrespective of the relation to study treatment. Due to the low number of participants enrolled at only 1 site, 0 reported due to risk of identification.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    TAK-954 0,1 mg
    Reporting group description
    		 TTAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.

    Serious adverse events
    		 TAK-954 0,1 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TAK-954 0,1 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Not applicable

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    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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