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    Clinical Trial Results:
    A trial aimed at enhancing immunity to Influenza in elderly individuals through reversal of immune senescence mediated by herpes virus infection.

    Summary
    EudraCT number
    		 2011-000092-13
    Trial protocol
    		 GB  
    Global end of trial date
    21 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jul 2022
    First version publication date
    10 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RG_10-292
    Additional study identifiers
    ISRCTN number
    		 ISRCTN24967173
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Birmingham
    Sponsor organisation address
    Room 119, Aston Webb Building, Edgbaston, , Birmingham, United Kingdom, B15 2TT
    Public contact
    Rachel Bruton , University of Birmingham , 44 01214148557, r.k.bruton@bham.ac.uk
    Scientific contact
    Professor Paul Moss, University of Birmingham , 44 01214142824, p.moss@bham.ac.uk
    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
    19 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part 1 : Feasibilty Study -The primary objective is to determine the efficacy of valaciclovir for reduction of the CMV-specific T cell response. Part 2 : Phase II Randomised Controlled Trial -The primary objective is to assess the value of valaciclovir in the augmentation of the immune response to influenza vaccination in donors aged ≥65 years.
    Protection of trial subjects
    Inclusion /exclusion criteria and safety reporting as per the protocol. A trial steering committee was also appointed.
    Background therapy
    		 N/A
    Evidence for comparator
    		 (i) No treatment. (ii) 500mg valaciclovir b.d. (iii) 1000mg valaciclovir b.d. (iv) 1000mg valaciclovir q.d.s. The comparators are different doses and regimes of the anti-viral drug Valaciclovir. The drug is licensed for suppression of CMV reactivation in a number of settings at a variety of concentrations. In the setting of renal transplantation a dose of 2gm q.d.s is associated with a profound reduction in the frequency of CMV reactivation. A dose of 1gm t.d.s in this setting has also shown efficacy in preventing viral reactivation. The drug has not been assessed for its ability to suppress CMV reactivation in immunocompetent donors and this is the subject of this study. The comparators were selected based on the lower range of that licensed in the clinical setting of immunosuppressed donors
    Actual start date of recruitment
    15 May 2012
    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 Kingdom: 38
    Worldwide total number of subjects
    38
    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)
    0
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The participants in the trial were recruited from GP surgeries within the West Midlands UK

    Pre-assignment
    Screening details
    		 102 individuals were assessed for eligibility Not Eligible (N=54) o CMV negative (N=31) o Inadequate CD4+ / CD8+ response (N=5) o Current medication / disease / planned surgery / holiday commitments (N=12) o Results of routine screening blood tests (N=5) o Ineligible under the original study criteria (N=1)

    Pre-assignment period milestones
    Number of subjects started
    		 38
    Number of subjects completed

    Period 1
    Period 1 title
    milestone 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    This part of the study is single blind. Patients and the clinical team knew which treatment group they were in; the laboratory did not. An unblinding strategy was therefore not needed for this part of the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 no treatment
    Arm description
    		 no treatment
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    as perscribed

    Arm title
    		 valaciclovir 500mg b.d.
    Arm description
    		 500mg Valaciclovir twice a day
    Arm type
    		 Active comparator

    Investigational medicinal product name
    valaciclovir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500mg twice a day

    Arm title
    		 valaciclovir 1000mg b.d.
    Arm description
    		 1000mg Valaciclovir twice a day
    Arm type
    		 Active comparator

    Investigational medicinal product name
    valaciclovir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000mg twice a day

    Arm title
    		 valaciclovir 1000mg q.d.s.
    Arm description
    		 1000mg Valaciclovir four times a day
    Arm type
    		 Active comparator

    Investigational medicinal product name
    valaciclovir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000mg four times a day

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This part of the study is single blind. Patients and the clinical team knew which treatment group they were in; the laboratory did not. In this case the laboratory staff have been classified as the assessor
    Number of subjects in period 1
    		no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Started
    10
    7
    10
    11
    Completed
    10
    7
    10
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    no treatment
    Reporting group description
    		 no treatment

    Reporting group title
    valaciclovir 500mg b.d.
    Reporting group description
    		 500mg Valaciclovir twice a day

    Reporting group title
    valaciclovir 1000mg b.d.
    Reporting group description
    		 1000mg Valaciclovir twice a day

    Reporting group title
    valaciclovir 1000mg q.d.s.
    Reporting group description
    		 1000mg Valaciclovir four times a day

    Reporting group values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s. Total
    Number of subjects
    		 10 7 10 11 38
    Age categorical
    Units: Subjects
        65-74 years
    		 7 4 6 7 24
        75 years and over
    		 3 3 4 4 14
    Gender categorical
    Units: Subjects
        Female
    		 4 3 3 6 16
        Male
    		 6 4 7 5 22
    Ethnicity
    Units: Subjects
        White British
    		 10 6 10 11 37
        Indian
    		 0 1 0 0 1
    flu vaccination
    Units: Subjects
        yes
    		 5 3 5 2 15
        no
    		 5 4 5 9 23
    pneumonia vaccination
    Units: Subjects
        yes
    		 4 0 2 1 7
        no
    		 6 7 8 10 31
    Shingles Vaccination
    Units: Subjects
        yes
    		 0 0 0 0 0
        no
    		 10 7 10 11 38
    BMI
    Units: BMI (kg/m2)
        arithmetic mean (standard deviation)
    		 28.2 ± 3.8 27.5 ± 4.0 27.1 ± 3 25.8 ± 4.3 -
    EQ-5D-Dl score
    Units: score
        arithmetic mean (standard deviation)
    		 0.92 ± 0.07 0.96 ± 0.05 0.9 ± 0.09 0.89 ± 0.14 -
    SF36 physical component score
    physical component score
    Units: score
        arithmetic mean (standard deviation)
    		 44.6 ± 13.5 46.7 ± 3.4 47.7 ± 5.5 42.9 ± 15.8 -
    SF36 (mental component score)
    mental component score
    Units: score
        arithmetic mean (standard deviation)
    		 60.9 ± 4.2 59.7 ± 5.0 61.7 ± 3.1 58.8 ± 6.7 -

    End points

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    End points reporting groups
    Reporting group title
    no treatment
    Reporting group description
    		 no treatment

    Reporting group title
    valaciclovir 500mg b.d.
    Reporting group description
    		 500mg Valaciclovir twice a day

    Reporting group title
    valaciclovir 1000mg b.d.
    Reporting group description
    		 1000mg Valaciclovir twice a day

    Reporting group title
    valaciclovir 1000mg q.d.s.
    Reporting group description
    		 1000mg Valaciclovir four times a day

    Primary: CD4+ CMV-specific response

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    End point title
    		 CD4+ CMV-specific response
    End point description
    results shown as a geometric mean ratio compared to no treatment
    End point type
    Primary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: % lymphocytes
        geometric mean (confidence interval 95%)
    0.44 (0.35 to 0.56)
    0.62 (0.43 to 0.91)
    1.15 (0.82 to 1.62)
    0.82 (0.59 to 1.14)
    Statistical analysis title
    		 Primary outcome analysis
    Statistical analysis description
    CD4+ CMV-specific response
    Comparison groups
    no treatment v valaciclovir 500mg b.d. v valaciclovir 1000mg b.d. v valaciclovir 1000mg q.d.s.
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Primary: CD8+ Tetramer+ response

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    End point title
    		 CD8+ Tetramer+ response
    End point description
    End point type
    Primary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: % lymphocytes
        geometric mean (confidence interval 95%)
    2.11 (1.59 to 2.80)
    0.92 (0.59 to 1.43)
    1.01 (0.70 to 1.47)
    1.1 (0.73 to 1.66)
    Statistical analysis title
    		 Primary outcome analysis
    Statistical analysis description
    CD8+ Tetramer+ response
    Comparison groups
    valaciclovir 500mg b.d. v valaciclovir 1000mg b.d. v no treatment v valaciclovir 1000mg q.d.s.
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Primary: CMV IgG titre

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    End point title
    		 CMV IgG titre
    End point description
    results shown as a geometric mean ratio compared to no treatment
    End point type
    Primary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: units
        geometric mean (confidence interval 95%)
    181.6 (148.7 to 221.7)
    1.11 (0.81 to 1.52)
    0.91 (0.69 to 1.20)
    1.0 (0.76 to 1.32)
    Statistical analysis title
    		 primary end point analysis
    Comparison groups
    no treatment v valaciclovir 500mg b.d. v valaciclovir 1000mg b.d. v valaciclovir 1000mg q.d.s.
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: CD4+ CD28- whole blood count (cells/µl)

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    End point title
    		 CD4+ CD28- whole blood count (cells/µl)
    End point description
    results shown as a geometric mean ratio compared to no treatment
    End point type
    Secondary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: cells/µl
        geometric mean (confidence interval 95%)
    23.8 (19.3 to 29.2)
    1.22 (0.89 to 1.69)
    0.99 (0.74 to 1.32)
    1.08 (0.81 to 1.44)
    No statistical analyses for this end point

    Secondary: CD8+ CD28- whole blood count (cells/µl)

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    End point title
    		 CD8+ CD28- whole blood count (cells/µl)
    End point description
    results shown as a geometric mean ratio compared to no treatment
    End point type
    Secondary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: (cells/µl)
        geometric mean (confidence interval 95%)
    147.6 (122.7 to 177.4)
    1.44 (1.08 to 1.92)
    1.09 (0.84 to 1.41)
    1.17 (0.9 to 1.5)
    No statistical analyses for this end point

    Secondary: SF36 physical component score

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    End point title
    		 SF36 physical component score
    End point description
    results shown as a difference compared to no treatment
    End point type
    Secondary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: score
        geometric mean (confidence interval 95%)
    45.0 (42.4 to 47.7)
    0.65 (-3.54 to 4.84)
    2.28 (-2.08 to 6.65)
    -0.38 (-4.13 to 3.38)
    No statistical analyses for this end point

    Secondary: SF36 mental component score

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    End point title
    		 SF36 mental component score
    End point description
    results shown as a difference compared to no treatment
    End point type
    Secondary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: score
        geometric mean (confidence interval 95%)
    59.6 (57.6 to 61.5)
    -0.60 (-3.65 to 2.45)
    -0.04 (-3.23 to 3.15)
    -0.78 (-3.52 to 1.97)
    No statistical analyses for this end point

    Secondary: EQ-5D-5L score

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    End point title
    		 EQ-5D-5L score
    End point description
    results shown as a difference compared to no treatment
    End point type
    Secondary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: score
        geometric mean (confidence interval 95%)
    0.89 (0.87 to 0.92)
    0.01 (-0.03 to 0.05)
    0.05 (0.01 to 0.08)
    0.008 (-0.03 to 0.05)
    No statistical analyses for this end point

    Secondary: Haemoglobin

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    End point title
    		 Haemoglobin
    End point description
    results shown as a difference compared to no treatment
    End point type
    Secondary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: g/l
        geometric mean (confidence interval 95%)
    137.6 (134.5 to 140.7)
    2.17 (-2.91 to 7.25)
    1.29 (-3.10 to 5.67)
    0.43 (-3.88 to 4.74)
    No statistical analyses for this end point

    Secondary: White blood cell count

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    End point title
    		 White blood cell count
    End point description
    End point type
    Secondary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: Cells x10 9/l
        geometric mean (confidence interval 95%)
    6.3 (5.7 to 6.9)
    0.55 (-0.37 to 1.47)
    -0.09 (-0.88 to 0.71)
    -0.52 (-1.3 to 0.26)
    No statistical analyses for this end point

    Secondary: neutrophils

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    End point title
    		 neutrophils
    End point description
    End point type
    Secondary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: cells x10 9/l
        geometric mean (confidence interval 95%)
    3.7 (3.2 to 4.2)
    0.52 (-0.23 to 1.27)
    0.06 (-0.6 to 0.71)
    -0.35 (-1.0 to 0.29)
    No statistical analyses for this end point

    Secondary: Platelets

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    End point title
    		 Platelets
    End point description
    End point type
    Secondary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: cells x10 9/l
        geometric mean (confidence interval 95%)
    223.5 (210.4 to 236.5)
    -0.99 (-22.28 to 0.29)
    5.13 (-13.77 to 14.04)
    6.8 (-11.16 to 14.76)
    No statistical analyses for this end point

    Secondary: lymphocytes

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    End point title
    		 lymphocytes
    End point description
    End point type
    Secondary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: cells x 10 9/l
        geometric mean (confidence interval 95%)
    1.8 (1.7 to 2.0)
    -0.06 (-0.31 to 0.18)
    -0.11 (-0.33 to 0.10)
    0.001 (-0.21 to 0.21)
    No statistical analyses for this end point

    Secondary: mean corpuscular volume (MCV)

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    End point title
    		 mean corpuscular volume (MCV)
    End point description
    End point type
    Secondary
    End point timeframe
    on treatment period, i.e. the first 6 months
    End point values
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Number of subjects analysed
    10
    7
    10
    11
    Units: fl
        geometric mean (confidence interval 95%)
    93.2 (91.4 to 95.0)
    2.73 (-0.04 to 5.51)
    4.64 (2.08 to 7.2)
    7.66 (5.07 to 10.25)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    from randomisation up until 12 months (6 months post treatment)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.2
    Reporting groups
    Reporting group title
    no treatment
    Reporting group description
    		 no treatment

    Reporting group title
    valaciclovir 500mg b.d.
    Reporting group description
    		 500mg Valaciclovir twice a day

    Reporting group title
    valaciclovir 1000mg b.d.
    Reporting group description
    		 1000mg Valaciclovir twice a day

    Reporting group title
    valaciclovir 1000mg q.d.s.
    Reporting group description
    		 1000mg Valaciclovir four times a day

    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: There were no non-serious adverse events that occurred at a frequency of >5%, therefore there are no events to be reported.
    Serious adverse events
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    2 / 10 (20.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Cardiac disorders
    chest pain
    Additional description: Chest Pain, Admitted to A&E for further investigation.
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    raised HbA,c
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Admitted to Hospital following a fall
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    hallucinate
    Additional description: hallucinated Admitted him to hospital. In hospital was diagnosed with pneumonia and septicemia following blood test and discharged 7 days later
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 no treatment valaciclovir 500mg b.d. valaciclovir 1000mg b.d. valaciclovir 1000mg q.d.s.
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)

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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.
    baseline characteristics have only been included for those who completed the trial
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