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    Clinical Trial Results:
    An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Doripenem in Pediatric Subjects 6 to 17 Years of age, Inclusive, With Cystic Fibrosis

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2015-001225-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 Mar 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Jun 2016
    First version publication date
    24 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    DORIPED1001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Johnson & Johnson Pharmaceutical Research & Development
    Sponsor organisation address
    Clinical Registry Group-JB BV Archimedesweg 29 , Leiden, Netherlands, 2333CM
    Public contact
    Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.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
    24 Mar 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Mar 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the pharmacokinetics of doripenem after a single administration of 30 milligram per kilogram of body weight (mg/kg) of doripenem as 4 hour intravenous (IV) infusion administered to paediatric subjects with cystic fibrosis (CF).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety was assessed based on treatment-emergent adverse events (TEAEs), including pre-study to post-study changes in physical examination findings, vital sign measurements, and clinical laboratory analyte values. A safety committee was established to ensure that the safety of the subjects was not compromised.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 May 2009
    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
    United States: 22
    Worldwide total number of subjects
    22
    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)
    10
    Adolescents (12-17 years)
    12
    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
    		 -

    Pre-assignment
    Screening details
    		 Twenty-two subjects were enrolled into the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Subjects more than or equal to (>=) 6 to less than (<) 12 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doripenem
    Investigational medicinal product code
    Other name
    Doribax
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Subjects were given a single dose of doripenem 30 milligram per kilogram of body weight (mg/kg) for 4 hour as IV infusion.

    Arm title
    		 Group 2
    Arm description
    		 Subjects >=12 to < 18 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doripenem
    Investigational medicinal product code
    Other name
    Doribax
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Subjects were given a single dose of doripenem 30 mg/kg for 4 hour as IV infusion. The maximum dose of doripenem was 1000 mg.

    Number of subjects in period 1
    		Group 1 Group 2
    Started
    10
    12
    Completed
    10
    10
    Not completed
    0
    2
         Adverse event, non-fatal
    -
    1
         Other
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Subjects more than or equal to (>=) 6 to less than (<) 12 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed.

    Reporting group title
    Group 2
    Reporting group description
    		 Subjects >=12 to < 18 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed.

    Reporting group values
    		 Group 1 Group 2 Total
    Number of subjects
    		 10 12 22
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 10 0 10
        Adolescents (12-17 years)
    		 0 12 12
        Adults (18-64 years)
    		 0 0 0
        From 65 to 84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.5 ( 1.35 ) 15.1 ( 1.98 ) -
    Title for Gender
    Units: subjects
        Female
    		 6 3 9
        Male
    		 4 9 13

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Subjects more than or equal to (>=) 6 to less than (<) 12 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed.

    Reporting group title
    Group 2
    Reporting group description
    		 Subjects >=12 to < 18 years with CF who were receiving treatment with another non-study antibiotic for an infection, colonization, or prophylaxis in a hospital or supervised outpatient clinic setting were observed.

    Subject analysis set title
    Pharmacokinetic Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Pharmacokinetic analysis set included all enrolled subjects who received study drug, and had Maximum Observed Plasma Concentration (Cmax) estimation.

    Primary: Maximum Observed Plasma Concentration (Cmax)

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) [1]
    End point description
    The Cmax is the maximum observed plasma concentration.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2.00, 4.00, 4.50, 5.00, 7.00, 9.00 hour after intravenous infusion
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    9 [2]
    10 [3]
    Units: microgram per millilitre (mcg/mL)
        arithmetic mean (standard deviation)
    29 ( 9.13 )
    19.9 ( 3.05 )
    Notes
    [2] - Pharmacokinetic Analysis Set
    [3] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Time to Reach Maximum Observed Plasma Concentration (Tmax)

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    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) [4]
    End point description
    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 4.5, 5, 7, 9 hours after intravenous infusion
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    9 [5]
    10 [6]
    Units: Hour
        median (full range (min-max))
    3.98 (2 to 4.18)
    3.98 (2 to 4)
    Notes
    [5] - Pharmacokinetic Analysis Set
    [6] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to last quantifiable time (AUC[0-last])

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time Zero to last quantifiable time (AUC[0-last]) [7]
    End point description
    AUC (last) is area under the plasma concentration-time curve from time zero to last quantifiable time.
    End point type
    Primary
    End point timeframe
    Pre-dose, 2, 4, 4.5, 5, 7, 9 hours after intravenous infusion
    Notes
    [7] - 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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    9 [8]
    10 [9]
    Units: microgram*hour per milliliter (mcg*h/mL)
        arithmetic mean (standard deviation)
    95.6 ( 31.2 )
    72.7 ( 11.8 )
    Notes
    [8] - Pharmacokinetic Analysis Set
    [9] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) [10]
    End point description
    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C (last)/lambda (z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
    End point type
    Primary
    End point timeframe
    Pre-dose; 2, 4, 4.5, 5, 7, 9 hours after intravenous infusion
    Notes
    [10] - 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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    9 [11]
    10 [12]
    Units: mcg*h/ml
        arithmetic mean (standard deviation)
    96.1 ( 31.7 )
    73 ( 11.8 )
    Notes
    [11] - Pharmacokinetic Analysis Set
    [12] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Plasma Decay Half-Life (t1/2)

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    End point title
    		 Plasma Decay Half-Life (t1/2) [13]
    End point description
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
    End point type
    Primary
    End point timeframe
    Pre-dose; 2, 4, 4.5, 5, 7, 9 hours after intravenous infusion
    Notes
    [13] - 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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    9 [14]
    10 [15]
    Units: Hours
        arithmetic mean (standard deviation)
    0.874 ( 0.159 )
    0.881 ( 0.0897 )
    Notes
    [14] - Pharmacokinetic Analysis Set
    [15] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Group 2
    Reporting group description
    		 Subjects who were receiving non-study antibiotic from >=12 years to <18 years of age was observed.

    Reporting group title
    Group 1
    Reporting group description
    		 Subjects who were receiving non-study antibiotic from more than or equal to (>=) 6 years to less than (<) 12 years of age was observed.

    Serious adverse events
    		 Group 2 Group 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 2 Group 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 12 (50.00%)
    7 / 10 (70.00%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Blood Bilirubin Increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Blood Creatinine Increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Pallor
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application Site Erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Application Site Pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Application Site Vesicles
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Infusion Site Erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Infusion Site Extravasation
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Infusion Site Irritation
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Pain in Extremity
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Feb 2009
    Protocol amendment 1 included revision of inclusion criterion to allow the flexibility to enroll subjects receiving antibiotic therapy outside the hospital and also for the subjects receiving antibiotics without an IV catheter in place. Withdrawal criterion for interrupted doripenem infusion was modified from interruption more than 5 minutes to more than 10 minutes.
    22 Jun 2009
    Protocol amendment 2 included withdrawal from study was modified to allow re-enrollment of subjects withdrawn for reasons other than safety. Instructions regarding pharmacokinetic sample collection in the cases where study drug administration could have been interrupted for less than or equal to 10 minutes were clarified.
    01 Oct 2009
    Protocol amendment 3 deleted an inclusion criterion for weight requirement (within the 5th and the 95th percentile), to allow enrollment of subjects with lower body weight. Study withdrawal section and dosage and administration section were updated to clarify that the subject was to be withdrawn if the total interruption in study drug administration occurred for more than 10 minutes.

    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
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