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    Clinical Trial Results:
    Pharmacokinetics of a new paediatric formulation of valacyclovir used for prophylaxis and treatment of VZV and HSV infections in children, phase II (VALID II)

    Summary
    EudraCT number
    2017-001451-30
    Trial protocol
    NL  
    Global end of trial date
    12 May 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Aug 2024
    First version publication date
    24 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UMCN-AKF12.07
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Radboud university medical center
    Sponsor organisation address
    Geert grooteplein Zuid 10, Nijmegen, Netherlands, 6525GA
    Public contact
    David Burger, Radboud university medical center, 31 243616405, david.burger@radboudumc.nl
    Scientific contact
    David Burger, Radboud university medical center, 31 243616405, david.burger@radboudumc.nl
    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
    06 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the pharmacokinetics of valacyclovir oral so-lution in children who have received stem cell transplanta-tion (plasma) by determining the AUC0-12, time above Ccrit, Cmax and Tmax of acyclovir and comparing them with Ccrit (0.18 mg/L)and AUCcrit24 (4.3 mg*h/L).
    Protection of trial subjects
    Subject’s parents have signed the Informed Consent Form prior to screening evaluations. Subject is willing to participate after study procedures are explained in comprehensible language for the child. A subject may decide to withdraw from the trial at any time. If so, the investigator must be informed immediately. The investigator may decide to terminate participation of a sub-ject if it is difficult to obtain blood samples, if there has been a violation of the protocol, if a serious adverse event occurs, or if it is in the best interest of the subject that he/she is withdrawn. If there is a medical reason for withdrawal, the subject will remain under the care of the investigator until the problem prompting withdrawal has been resolved or until referral to his general practitioner. On the basis of the occurrence of adverse events, the investigator may decide to discontinue the trial. Data are collected pseudonymised.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Sep 2019
    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
    Netherlands: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    7
    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
    Seven patients (4 boys, 3 girls) were included in the Princes Maxima Centre in Utrecht, The Netherlands. Five patients in the range of 1-6 years old and two patients in the range of 7-12 years old. All seven patients received a stemcell transplantation and therefore used prophylactic valacyclovir.

    Pre-assignment
    Screening details
    Subjects must meet the following criteria to be eligible for participation in this trial: 1. Subject is in the age of 1-12 years. 2. Subject has an indication for (val)acyclovir prophylaxis and are planned to receive valacyclovir oral solution. 3. Subject is managed with a central venous catheter (CVC/Port-a-Cath).

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

    Arms
    Arm title
    valacyclovir
    Arm description
    Subjects will receive the following medication (according to standard of care): - Valacyclovir oral solution 20 mg/mL FNA (national standard formulation) Patients < 40 kg will receive 10 mg/kg and patients > 40 kg will receive 500 mg (25 mL) valacylcovir as oral solution at approximately 8 AM.
    Arm type
    standard of care

    Investigational medicinal product name
    valacyclovir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Valacyclovir oral solution 20 mg/mL FNA (national standard formulation) Patients < 40 kg will receive 10 mg/kg and patients > 40 kg will receive 500 mg (25 mL) valacylcovir as oral solution at approximately 8 AM.

    Number of subjects in period 1
    valacyclovir
    Started
    7
    Completed
    7

    Baseline characteristics

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

    Reporting group values
    screening Total
    Number of subjects
    7 7
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    5 (2 to 8) -
    Gender categorical
    Units: Subjects
        Female
    3 3
        Male
    4 4

    End points

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    End points reporting groups
    Reporting group title
    valacyclovir
    Reporting group description
    Subjects will receive the following medication (according to standard of care): - Valacyclovir oral solution 20 mg/mL FNA (national standard formulation) Patients < 40 kg will receive 10 mg/kg and patients > 40 kg will receive 500 mg (25 mL) valacylcovir as oral solution at approximately 8 AM.

    Primary: AUC

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    End point title
    AUC [1]
    End point description
    End point type
    Primary
    End point timeframe
    over 12 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: only descirptive satistics were done
    End point values
    valacyclovir
    Number of subjects analysed
    7
    Units: mg*h/L
        median (inter-quartile range (Q1-Q3))
    11.9 (10 to 12)
    No statistical analyses for this end point

    Secondary: % above Crit AUC (4.3)

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    End point title
    % above Crit AUC (4.3)
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    valacyclovir
    Number of subjects analysed
    7
    Units: %
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    entire study
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    none
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: No adverse events were reported

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Apr 2015
    1 Including children with a Hb between 5 and 6 mmol/L The children who already use valacyclovir oral solution appeared to have in some cases a Hb below 6 mmol/L. Since these children belong to the population who will use this oral solu-tion, inclusion of these children will be valuable. The amount of blood that will be taken is al-ready low, maximum om 25 ml in total. The percentage blood taken, will never be more than 5%. According to the WHO Bulletin on blood sample volume in child health research, the effect on Hb is minimal if the total amount of blood loss is below 5%. 2 Including children between one and two years old The oral solution of valacyclovir is already used in children between one and two years old. When considering the pharmacokinetics of valacyclovir in children in between this age, there is barely any difference between children between one and two years old and children be-tween two and five years old. Therefore it will be valuable to include these children in this study.

    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 did not fully recruit
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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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