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    Clinical Trial Results:
    Study of efficacy and safety of V0305 solution in children suffering from Iron Deficiency Anaemia (IDA).

    Summary
    EudraCT number
    2015-000995-88
    Trial protocol
    PL  
    Global end of trial date
    24 Jan 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Jul 2019
    First version publication date
    24 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V00305SB301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    PIERRE FABRE MEDICAMENT
    Sponsor organisation address
    45 Place Abel Gance, Boulogne-Billancourt, France, 92100
    Public contact
    Clinical Development Physician A.Boudribila, Institut de Recherche Pierre Fabre, +33 5 34 50 60 98, asmaa.boudribila@pierre-fabre.com
    Scientific contact
    Clinical Development Physician A.Boudribila, Institut de Recherche Pierre Fabre, +33 5 34 50 60 98, asmaa.boudribila@pierre-fabre.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To document the effect of V0305 (ferrous sulphate solution: Tardyferon solution 20 mg/mL) administered during 3 months (princeps period) on the blood haemoglobin level in children with IDA .
    Protection of trial subjects
    The study was conducted in accordance with Good Clinical Practice (CPMP/ICH/135/95), the Declaration of Helsinki and its subsequent amendments thereto, and national regulations. In case of gastro-intestinal disorders, reported by the parent(s)/guardian(s) to the Investigator (phone call or visit), the following guidance was recommended to adapt the daily posology (initially planned to be an equivalent of 2 mg/kg once daily): - Firstly, the daily dosage of an equivalent of 2 mg/kg/day had to be administered in two intakes. - Secondly, if the intolerance persisted, the daily dosage had to be reduced to an equivalent of 1 mg/kg/day. - Finally, if the intolerance persisted, the Investigator had to discontinue the treatment and, in case of intolerance reported at phone call, an unscheduled visit had to be performed to withdraw the subject from the study.
    Background therapy
    There was no systematic concomitant administration of any other product than the investigational product.
    Evidence for comparator
    The primary objective of this clinical study was to document the efficacy of this new formulation of ferrous sulphate in children with mild-to-moderate IDA. The assessment of the main and key criteria, i.e., the level of the blood haemoglobin (Hb) and the level of serum ferritin, is particularly objective. Furthermore, considering the consequences of IDA (fatigue, impaired growth and development in infants), it would not have been ethical to maintain children suffering from IDA on placebo.
    Actual start date of recruitment
    06 Jun 2016
    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
    Poland: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    100
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    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
    13 centres located in Poland were initiated and 10 recruited patients. 100 patients were screened and enrolled, 21 were included, treated and analysed.

    Pre-assignment
    Screening details
    Female or male child, - aged between 6 and 53 months (inclusive), - with 7.0 kg ≤ body weight ≤ 20.0 kg, - with a mild or moderate IDA: o blood Hb level: 70 to 109 g/L o serum ferritin < 12 μg/L 79/100 enrolled patients were not included as their blood Hb level and serum ferritin level did not meet the minimal threshold for IDA diagnosis.

    Period 1
    Period 1 title
    3-month Treatment Period
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Baseline FAS
    Arm description
    As it is a single-arm study, the Baseline data of the FAS group (see definition of full analysis set) are considered to be those of this arm.
    Arm type
    Experimental

    Investigational medicinal product name
    Tardyferon solution 20 mg/mL
    Investigational medicinal product code
    V0305
    Other name
    Liquid ferrous sulphate
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The prescribed initial dosage per day had to be an equivalent of 2 mg/kg/day of V0305 administered once a day. The daily dosage had to be administered considering the child’s weight measured at screening (V1) and had not to be adjusted according to the weight during the study. The daily posology (number of intake(s) and/or dosage) could be modified in case of gastrointestinal disorders reported to the Investigator at each time during the treatment periods (phone calls or visits): - Firstly, this daily dosage had to be administered in 2 intakes, - Secondly, if the intolerance persisted, the daily dosage had to be reduced to an equivalent of 1 mg/kg/day (once daily) - Finally, if the intolerance still persisted, the treatment had to be stopped.

    Arm title
    3-month FAS
    Arm description
    As it is a single-arm study, the Month 3 data of the FAS group (see definition of full analysis set) are considered to be those of this arm.
    Arm type
    Experimental

    Investigational medicinal product name
    Tardyferon solution 20 mg/mL
    Investigational medicinal product code
    V0305
    Other name
    Liquid ferrous sulphate
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The prescribed initial dosage per day had to be an equivalent of 2 mg/kg/day of V0305 administered once a day. The daily dosage had to be administered considering the child’s weight measured at screening (V1) and had not to be adjusted according to the weight during the study. The daily posology (number of intake(s) and/or dosage) could be modified in case of gastrointestinal disorders reported to the Investigator at each time during the treatment periods (phone calls or visits): - Firstly, this daily dosage had to be administered in 2 intakes, - Secondly, if the intolerance persisted, the daily dosage had to be reduced to an equivalent of 1 mg/kg/day (once daily) - Finally, if the intolerance still persisted, the treatment had to be stopped.

    Arm title
    Baseline PP set
    Arm description
    As it is a single-arm study, the Baseline data of the PP set (see PP set definition) are considered to be those of this arm
    Arm type
    Experimental

    Investigational medicinal product name
    Tardyferon solution 20 mg/mL
    Investigational medicinal product code
    V0305
    Other name
    Liquid ferrous sulphate
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The prescribed initial dosage per day had to be an equivalent of 2 mg/kg/day of V0305 administered once a day. The daily dosage had to be administered considering the child’s weight measured at screening (V1) and had not to be adjusted according to the weight during the study. The daily posology (number of intake(s) and/or dosage) could be modified in case of gastrointestinal disorders reported to the Investigator at each time during the treatment periods (phone calls or visits): - Firstly, this daily dosage had to be administered in 2 intakes, - Secondly, if the intolerance persisted, the daily dosage had to be reduced to an equivalent of 1 mg/kg/day (once daily) - Finally, if the intolerance still persisted, the treatment had to be stopped.

    Arm title
    3-month PP set
    Arm description
    As it is a single-arm study, the Month 3 data of the PP set (see PP set definition) are considered to be those of this arm
    Arm type
    Experimental

    Investigational medicinal product name
    Tardyferon solution 20 mg/mL
    Investigational medicinal product code
    V0305
    Other name
    Liquid ferrous sulphate
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The prescribed initial dosage per day had to be an equivalent of 2 mg/kg/day of V0305 administered once a day. The daily dosage had to be administered considering the child’s weight measured at screening (V1) and had not to be adjusted according to the weight during the study. The daily posology (number of intake(s) and/or dosage) could be modified in case of gastrointestinal disorders reported to the Investigator at each time during the treatment periods (phone calls or visits): - Firstly, this daily dosage had to be administered in 2 intakes, - Secondly, if the intolerance persisted, the daily dosage had to be reduced to an equivalent of 1 mg/kg/day (once daily) - Finally, if the intolerance still persisted, the treatment had to be stopped.

    Number of subjects in period 1
    Baseline FAS 3-month FAS Baseline PP set 3-month PP set
    Started
    21
    21
    11
    11
    Completed
    17
    17
    11
    11
    Not completed
    4
    4
    0
    0
         Wrong inclusion
    2
    2
    -
    -
         Adverse event, non-fatal
    2
    2
    -
    -
    Period 2
    Period 2 title
    Additional 3-month Treatment Period
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    6-month FAS
    Arm description
    As it is a single-arm study, the Month 6 data of the FAS patient(s) who entered the additional 3-month period are considered to be those of this arm.
    Arm type
    Experimental

    Investigational medicinal product name
    Tardyferon solution 20 mg/mL
    Investigational medicinal product code
    V0305
    Other name
    Liquid ferrous sulphate
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The prescribed initial dosage per day had to be an equivalent of 2 mg/kg/day of V0305 administered once a day. The daily dosage had to be administered considering the child’s weight measured at screening (V1) and had not to be adjusted according to the weight during the study. The daily posology (number of intake(s) and/or dosage) could be modified in case of gastrointestinal disorders reported to the Investigator at each time during the treatment periods (phone calls or visits): - Firstly, this daily dosage had to be administered in 2 intakes, - Secondly, if the intolerance persisted, the daily dosage had to be reduced to an equivalent of 1 mg/kg/day (once daily) - Finally, if the intolerance still persisted, the treatment had to be stopped.

    Number of subjects in period 2
    6-month FAS
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    3-month Treatment Period
    Reporting group description
    As it is a single-arm study, the 21 patients of this group are those who were included and treated.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The protocol defined the enrolled patients as the patients selected at the end of the pre-assignment/-enrolment visit (V1) and whose parents signed an informed consent of participation. Patients were definitely included after all selection criteria were met as attested at the end of the assignment/inclusion visit (V2). At the end of V2, 21 patients were definitely included and assigned to treatment.
    Reporting group values
    3-month Treatment Period Total
    Number of subjects
    21 21
    Age categorical
    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)
    21 21
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    0 0
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    10.4 ± 3.9 -
    Gender categorical
    Units: Subjects
        Female
    4 4
        Male
    17 17
    Race
    Units: Subjects
        White
    21 21
        Asian
    0 0
        Black
    0 0
        Other
    0 0
    Breastfeeding at enrolment
    Units: Subjects
        Yes
    9 9
        No
    12 12
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    9.54 ± 1.79 -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients treated: analysed for all efficacy and safety oucomes.

    Subject analysis set title
    PP set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients treated with available data at baseline and at Month 3 on blood Hb and without major protocol deviations or other potential risk of primary analysis bias

    Subject analysis sets values
    Full Analysis Set (FAS) PP set
    Number of subjects
    21
    11
    Age categorical
    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)
    21
    11
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    10.4 ± 3.9
    ±
    Gender categorical
    Units: Subjects
        Female
    4
    2
        Male
    17
    9
    Race
    Units: Subjects
        White
    21
    11
        Asian
    0
    0
        Black
    0
    0
        Other
    0
    0
    Breastfeeding at enrolment
    Units: Subjects
        Yes
    9
        No
    12
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    9.54 ± 1.79
    ±

    End points

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    End points reporting groups
    Reporting group title
    Baseline FAS
    Reporting group description
    As it is a single-arm study, the Baseline data of the FAS group (see definition of full analysis set) are considered to be those of this arm.

    Reporting group title
    3-month FAS
    Reporting group description
    As it is a single-arm study, the Month 3 data of the FAS group (see definition of full analysis set) are considered to be those of this arm.

    Reporting group title
    Baseline PP set
    Reporting group description
    As it is a single-arm study, the Baseline data of the PP set (see PP set definition) are considered to be those of this arm

    Reporting group title
    3-month PP set
    Reporting group description
    As it is a single-arm study, the Month 3 data of the PP set (see PP set definition) are considered to be those of this arm
    Reporting group title
    6-month FAS
    Reporting group description
    As it is a single-arm study, the Month 6 data of the FAS patient(s) who entered the additional 3-month period are considered to be those of this arm.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients treated: analysed for all efficacy and safety oucomes.

    Subject analysis set title
    PP set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients treated with available data at baseline and at Month 3 on blood Hb and without major protocol deviations or other potential risk of primary analysis bias

    Primary: Blood Hb Level

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    End point title
    Blood Hb Level [1]
    End point description
    All statistical results were considered within a descriptive perspective and no statistical test was performed. The primary efficacy outcome, blood Hb at Month 3, was analysed in terms of value and change from baseline. Handling of drop-outs (for efficacy outcomes): in case of premature withdrawal between Week 3 (inclusive) and Month 3, the Observed Cases approach was used with the premature withdrawal visit replacing the Month 3 visit. In case of premature withdrawal before Week 3, Hb value was considered as missing at Month 3.
    End point type
    Primary
    End point timeframe
    - For the Baseline group: last sampling before administration (Day 1) - For the 3-month group: between Day 83 and Day 97
    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 statistical analysis was purely descriptive with no test performed. It can only be added that the 95% CI of the mean at Month 3 was [116.1;123.2] g/L, with a CI half-width of 3.6 g/L. The CI half-width was inferior to that initially planned for sample size determination (4 g/L), confirming the accuracy of the primary outcome CI.
    End point values
    Baseline FAS 3-month FAS Baseline PP set 3-month PP set
    Number of subjects analysed
    19 [2]
    19 [3]
    11
    11
    Units: g/l
        arithmetic mean (standard deviation)
    99.7 ± 7.6
    119.7 ± 7.4
    96.9 ± 7.8
    121.1 ± 7.6
    Notes
    [2] - 2 subjects with missing data
    [3] - 2 subjects with missing data
    No statistical analyses for this end point

    Secondary: Hb Responders

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    End point title
    Hb Responders [4]
    End point description
    Number of subjects with blood Hb level >= 110 g/L
    End point type
    Secondary
    End point timeframe
    Day 83 - 97
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As it is a single-arm, open-label study, the Baseline-FAS and the 3-Month FAS are the same groups. This endpoint was analysed at Month 3 and, as it was a secondary endpoint, was only analysed in the FAS. Therefore, the statistics are only reported in the 3-month FAS arm.
    End point values
    3-month FAS
    Number of subjects analysed
    19
    Units: Number of subjects
    18
    No statistical analyses for this end point

    Secondary: Serum ferritin level

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    End point title
    Serum ferritin level [5]
    End point description
    End point type
    Secondary
    End point timeframe
    - For the Baseline group: last sampling before administration (Day 1) - For the 3-month group: between Day 83 and Day 97
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As this endpoint was a secondary endpoint, it was only analysed in the FAS. Therefore, the statistics are only reported in the Baseline FAS arm (baseline data) and the 3-month FAS arm (Month 3 data).
    End point values
    Baseline FAS 3-month FAS
    Number of subjects analysed
    19 [6]
    19
    Units: µg/L
        arithmetic mean (standard deviation)
    6.4 ± 3.0
    31.5 ± 19.4
    Notes
    [6] - 2 missing data
    No statistical analyses for this end point

    Secondary: Ferritin Responders

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    End point title
    Ferritin Responders [7]
    End point description
    Number of subjects with serum ferritin level >= 12µg/L
    End point type
    Secondary
    End point timeframe
    Day 83-97
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As it is a single-arm, open-label study, the Baseline-FAS and the 3-Month FAS are the same groups. This endpoint was analysed at Month 3 and, as it was a secondary endpoint, was only analysed in the FAS. Therefore, the statistics are only reported in the 3-month FAS arm.
    End point values
    3-month FAS
    Number of subjects analysed
    19
    Units: subjects
    16
    No statistical analyses for this end point

    Secondary: Acceptability (for parents)

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    End point title
    Acceptability (for parents) [8]
    End point description
    Parents rated the acceptability of the treatment (taste-tolerability-ease of use)
    End point type
    Secondary
    End point timeframe
    Day 83-97 or end of study if before Month 3
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As it is a single-arm, open-label study, the Baseline-FAS and the 3-Month FAS are the same groups. This endpoint was analysed at Month 3 and, as it was a secondary endpoint, was only analysed in the FAS. Therefore, the statistics are only reported in the 3-month FAS arm.
    End point values
    3-month FAS
    Number of subjects analysed
    21
    Units: subjects
        Very good
    5
        Good
    12
        Moderate
    3
        Not good
    1
        Not good at all
    0
    No statistical analyses for this end point

    Secondary: Overall satisfaction (of Investigators)

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    End point title
    Overall satisfaction (of Investigators) [9]
    End point description
    Investigators rated their satisfaction regarding the effect on the child's status
    End point type
    Secondary
    End point timeframe
    Day 83-97 or end of study if before Month 3
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As it is a single-arm, open-label study, the Baseline-FAS and the 3-Month FAS are the same groups. This endpoint was analysed at Month 3 and, as it was a secondary endpoint, was only analysed in the FAS. Therefore, the statistics are only reported in the 3-month FAS arm.
    End point values
    3-month FAS
    Number of subjects analysed
    21
    Units: Subjects
        Very satisfied
    8
        Satisfied
    11
        Moderately satisfied
    2
        Not satisfied
    0
        Not satisfied at all
    0
    No statistical analyses for this end point

    Secondary: Ease of dose adaptation (for Investigators)

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    End point title
    Ease of dose adaptation (for Investigators) [10]
    End point description
    Investigators rated the ease of dose adaptation with the pipette
    End point type
    Secondary
    End point timeframe
    Day 83-97 or end of study if before Month 3
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As it is a single-arm, open-label study, the Baseline-FAS and the 3-Month FAS are the same groups. This endpoint was analysed at Month 3 and, as it was a secondary endpoint, was only analysed in the FAS. Therefore, the statistics are only reported in the 3-month FAS arm.
    End point values
    3-month FAS
    Number of subjects analysed
    21
    Units: Subjects
        Very easy
    8
        Easy
    13
        Moderately easy
    0
        Not easy
    0
        Not easy at all
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Whole study period + 30 days for serious AEs; treatment period for non serious treatment-emergent AEs
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Full analysis set
    Reporting group description
    All patients treated

    Serious adverse events
    Full analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    Full analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 21 (33.33%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
    Additional description: Reported term "Stomachache" = only drug related AE
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Exanthema subitum
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Laryngitis viral
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Viral rash
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Nov 2017
    Besides administrative changes, the section on adverse events was updated to mention the new current version of the Investigator's Brochure, the expected date of last completed subject was updated, and the definition of the Per Protocol set was modified (the minimal treatment exposure was modified from 90 days to 83 days, to be in line with the possibility for the Subject to perform V4 at 90 ± 7 days) . Moreover, the opening of 5 new study centres was recorded.
    05 Jun 2018
    Mentioned the Local Study Manager leaving (with no replacement). Changed the expected date of the last patient's study end

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    31 Jul 2018
    Despite measures were taken to help with recruitment, recruitment difficulties persisted, and it was decided to prematurely stop the recruitment on July 31, 2018 after 100 subjects had been screened. For all patients already recruited, the study was continued.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    - The number of included patients was lower than expected (21 vs 50) due to premature recruitment stop. - A high % of patients was excluded from the PP set (48%). Nevertheless, the primary outcome results were supported by the PP analysis.
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