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    Clinical Trial Results:
    Phase IV Study of Rasburicase for Treatment of Hyperuricemia in Patients With Tumoral Lysis Syndrome

    Summary
    EudraCT number
    		 2014-003989-24
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Jan 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2016
    First version publication date
    18 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    L_9436
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00302653
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi-aventis Farmacêutica Ltda
    Sponsor organisation address
    Avenida Major Sylvio de Magalhães Padilha, 5.200. Edifício Atlanta - Jd. Morumbi , São Paulo, Brazil, 05693-000
    Public contact
    Trial Transparency Team, Sanofi-aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi-aventis recherche & développement, Contact-US@sanofi.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 Mar 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to determine if rasburicase was effective and safety to treat subjects with hyperuricemia.
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Feb 2006
    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
    Brazil: 33
    Worldwide total number of subjects
    33
    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)
    2
    Children (2-11 years)
    22
    Adolescents (12-17 years)
    9
    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 enrolled at 3 sites in Brazil between 16 February 2006 and 30 October 2006.

    Pre-assignment
    Screening details
    		 A total of 33 subjects were screened of whom 32 subjects were treated.

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

    Arms
    Arm title
    		 Rasburicase
    Arm description
    		 Rasburicase for 3-7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rasburicase
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Rasburicase 0.20 mg/kg once a day.

    Number of subjects in period 1
    		Rasburicase
    Started
    33
    Treated
    32
    Completed
    26
    Not completed
    7
         Transference to other institution
    1
         Death
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rasburicase
    Reporting group description
    		 Rasburicase for 3-7 days.

    Reporting group values
    		 Rasburicase Total
    Number of subjects
    		 33 33
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.4 ± 4.7 -
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 15 15
    Race
    Units: Subjects
        Caucasian
    		 13 13
        Black
    		 1 1
        Black-caucasian biracial
    		 19 19
    Diagnosis
    Units: Subjects
        Leukemia
    		 21 21
        Lymphoma
    		 10 10
        Other (Neuroblastoma)
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Rasburicase
    Reporting group description
    		 Rasburicase for 3-7 days.

    Primary: Percentage of Subjects with Uric Acid Levels- ITT Population and PP Population

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    End point title
    		 Percentage of Subjects with Uric Acid Levels- ITT Population and PP Population [1]
    End point description
    Intention-To-Treat (ITT) population included all subjects who received at least one dose of rasburicase, performed baseline and 24-48 hours or 28± 3 days uric acid exam. Per-Protocol (PP) Population included all subjects who received at least one dose of rasburicase, performed baseline and 24-48 hours uric acid exams and did not fit in any relevant protocol violation criteria. Analysis was performed on ITT and PP population. Under NRV indicated that uric acid levels were below the normal reference values and upper NRV indicated uric acid levels were above the normal reference values.
    End point type
    Primary
    End point timeframe
    24-48 hours
    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: Statistical analysis could not be provided due to EudraCT format constraint for single arm study.
    End point values
    		 Rasburicase
    Number of subjects analysed
    21
    Units: percentage of subjects
    number (not applicable)
        ITT Population: Under NRV (n=21)
    90.5
        ITT Population: Normal (n=21)
    4.8
        ITT Population: Upper NRV (n=21)
    0
        ITT Population: Undefined/undetectable (n=21)
    4.8
        PP Population: Under NRV (n=20)
    90
        PP Population: Normal (n=20)
    5
        PP Population: Upper NRV (n=20)
    0
        PP Population: Undefined/undetectable (n=20)
    5
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Uric Acid Levels- ITT Population and PP Population

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    End point title
    		 Percentage of Subjects with Uric Acid Levels- ITT Population and PP Population [2]
    End point description
    Analysis was performed on ITT and PP population.
    End point type
    Primary
    End point timeframe
    28 days post 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: Statistical analysis could not be provided due to EudraCT format constraint for single arm study.
    End point values
    		 Rasburicase
    Number of subjects analysed
    19
    Units: percentage of subjects
    number (not applicable)
        ITT Population: Under NRV (n=19)
    10.5
        ITT Population: Normal (n=19)
    36.8
        ITT Population: Upper NRV (n=19)
    0
        ITT Population: Not Done (n=19)
    52.6
        PP Population: Under NRV (n=18)
    11.1
        PP Population: Normal (n=18)
    38.9
        PP Population: Upper NRV (n=18)
    0
        PP Population: Not Done (n=18)
    50
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Creatinine Levels - ITT Population and PP Population

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    End point title
    		 Percentage of Subjects with Creatinine Levels - ITT Population and PP Population
    End point description
    Analysis was performed on ITT and PP population.
    End point type
    Secondary
    End point timeframe
    24-48 hours
    End point values
    		 Rasburicase
    Number of subjects analysed
    21
    Units: percentage of subjects
    number (not applicable)
        ITT Population: Under NRV (n=21)
    23.8
        ITT Population: Normal (n=21)
    42.9
        ITT Population: Upper NRV (n=21)
    19
        ITT Population: Not done (n=21)
    14.3
        PP Population: Under NRV (n=20)
    25
        PP Population: Normal (n=20)
    40
        PP Population: Upper NRV (n=20)
    20
        PP Population: Not done (n=20)
    15
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Creatinine Levels - ITT Population and PP Population

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    End point title
    		 Percentage of Subjects with Creatinine Levels - ITT Population and PP Population
    End point description
    Analysis was performed on ITT and PP population.
    End point type
    Secondary
    End point timeframe
    28 days post treatment
    End point values
    		 Rasburicase
    Number of subjects analysed
    19
    Units: percentage of subjects
    number (not applicable)
        ITT Population: Under NRV (n=19)
    21.1
        ITT Population: Normal (n=19)
    47.4
        ITT Population: Upper NRV (n=19)
    5.3
        ITT Population: Not done (n=19)
    26.3
        PP Population: Under NRV (n=18)
    22.2
        PP Population: Normal (n=18)
    44.4
        PP Population: Upper NRV (n=18)
    5.6
        PP Population: Not done (n=18)
    27.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (4 weeks after last medication dose) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during the 'time of first injection until last visit'. One death is not reported as subject did not receive any study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 No Coding Applied
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Rasburicase
    Reporting group description
    		 Rasburicase for 3 -7 days.

    Serious adverse events
    		 Rasburicase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 32 (59.38%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Diarrhea + Swelling
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    Sepsis + Pancytopenia
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia + Sara
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac congestive insufficiency
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Bleeding
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Febrile neutropenia
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Diarrhea
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Febrile granulocytopenia
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Seizure with transitory heparesis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epigastric pain
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Creatinin level increase
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Perianal hyperemia
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Central nervous system bleeding
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Oliguria + Hypovolemia + Cardiac congestive insufficiency + Acute lung edema
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Rasburicase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 32 (71.88%)
    General disorders and administration site conditions
    Febrile neutropenia
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Allergic reaction
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    3
    Ankle pain
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    11 / 32 (34.38%)
         occurrences all number
    16
    Nausea
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    5
    Headache
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    4
    Diarrhea
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Hepatic enzymes increase
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Fever
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    6
    Petechiase
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Dry cough
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Epigastric pain
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Emesis
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Lack of appetite
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Mucositis
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2

    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.
    This study is considered as an “article 46” study by the EMA, although the completion date precedes 26 January 2007. Therefore this date was modified to allow posting.
    For support, Contact us.
    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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