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    Clinical Trial Results:
    A multicenter, open-label, single-arm study to evaluate the single-dose pharmacokinetics, acceptability and safety of famciclovir oral pediatric formulation in infants 1 month to <1 year of age with herpes simplex virus infection

    Summary
    EudraCT number
    		 2006-005010-12
    Trial protocol
    		 DE  
    Global end of trial date
    17 Nov 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    31 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CFAM810B2301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00448227
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office , Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office , Novartis Pharma AG, +41 613241111,
    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
    17 Nov 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Nov 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the pharmacokinetics (PK) of a single dose of famciclovir in subjects aged 1 month to less than (<)1 year who were infected or at risk of infection by herpes simplex virus.
    Protection of trial subjects
    No rescue medication was allowed in the study. Follow-up medical care was provided to all subjects who were prematurely withdrew from the study, or refereed for appropriate ongoing care by the investigator.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Oct 2007
    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
    Guatemala: 3
    Country: Number of subjects enrolled
    United States: 11
    Country: Number of subjects enrolled
    Germany: 4
    Worldwide total number of subjects
    18
    EEA total number of subjects
    4
    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)
    18
    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
    		 The study was conducted at 10 centres in 3 countries.

    Pre-assignment
    Screening details
    		 A total of 18 subjects were enrolled into the study.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open label, hence no blinding was performed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: 1 month to <3 months
    Arm description
    		 Subjects aged 1 month to less than <3 months received a single, individualised dose of famciclovir between 25-50 mg based on body weight.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Famciclovir
    Investigational medicinal product code
    FAM810
    Other name
    Pharmaceutical forms
    Chewable capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Weight stratified single dose of famciclovir (25-50 mg) was administered. The content of sprinkle capsules was mixed with Ora-Sweet® just prior to dosing

    Arm title
    		 Group 2: 3 month to <6 months
    Arm description
    		 Subjects aged 3 month to <6 months received a single, individualised dose of famciclovir between 50-100 mg based on body weight.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Famciclovir
    Investigational medicinal product code
    FAM810
    Other name
    Pharmaceutical forms
    Chewable capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Weight stratified single dose of famciclovir (50-100 mg) was administered. The content of sprinkle capsules was mixed with Ora-Sweet® just prior to dosing

    Arm title
    		 Group 3: 6 month to 12 months
    Arm description
    		 Subjects aged 6 month to 12 months received a single, individualised dose of famciclovir between 75-175 mg based on body weight.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Famciclovir
    Investigational medicinal product code
    FAM810
    Other name
    Pharmaceutical forms
    Chewable capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Weight stratified single dose of famciclovir (75-175 mg) was administered. The content of sprinkle capsules was mixed with Ora-Sweet® just prior to dosing

    Number of subjects in period 1
    		Group 1: 1 month to <3 months Group 2: 3 month to <6 months Group 3: 6 month to 12 months
    Started
    8
    5
    5
    Completed
    8
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 18 18
    Age categorical
    Units: Subjects
        1 to <3 months
    		 8 8
        3 to <6 months
    		 5 5
        6 to 12 months
    		 5 5
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 4 ( 3.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Group 1: 1 month to <3 months
    Reporting group description
    		 Subjects aged 1 month to less than <3 months received a single, individualised dose of famciclovir between 25-50 mg based on body weight.

    Reporting group title
    Group 2: 3 month to <6 months
    Reporting group description
    		 Subjects aged 3 month to <6 months received a single, individualised dose of famciclovir between 50-100 mg based on body weight.

    Reporting group title
    Group 3: 6 month to 12 months
    Reporting group description
    		 Subjects aged 6 month to 12 months received a single, individualised dose of famciclovir between 75-175 mg based on body weight.

    Primary: Time to maximum plasma concentration (Tmax) of penciclovir, the active metabolite of the prodrug famciclovir

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    End point title
    		 Time to maximum plasma concentration (Tmax) of penciclovir, the active metabolite of the prodrug famciclovir [1]
    End point description
    Tmax was defined as the time taken to reach the maximum plasma concentration of penciclovir. The analysis was performed in the pharmacokinetic (PK) population defined as all subjects with evaluable penciclovir concentration data. Here, "Number of subjects analysed" signifies those subjects evaluable for time to maximum plasma concentration for each arm, respectively.
    End point type
    Primary
    End point timeframe
    30 minutes, 1 hour, 4 hour and 6 hours (Post-dose)
    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 descriptive summary statistics was planned for this outcome measure
    End point values
    		 Group 1: 1 month to <3 months Group 2: 3 month to <6 months Group 3: 6 month to 12 months
    Number of subjects analysed
    7
    2
    3
    Units: Hour(s)
        median (full range (min-max))
    1 (1 to 5.17)
    4 (1 to 4.17)
    1.02 (0.58 to 1.1)
    No statistical analyses for this end point

    Primary: Maximum Plasma Concentration (Cmax) of penciclovir

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    End point title
    		 Maximum Plasma Concentration (Cmax) of penciclovir [2]
    End point description
    Cmax was defined as the maximum plasma concentration of penciclovir, the active metabolite of the prodrug famciclovir. The analysis was performed in the pharmacokinetic (PK) population defined as all subjects with evaluable penciclovir concentration data. Here, "Number of subjects analysed" signifies those subjects evaluable for maximum plasma concentration for each arm, respectively.
    End point type
    Primary
    End point timeframe
    30 minutes, 1 hour, 4 hour and 6 hours (Post-dose)
    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: Only descriptive summary statistics was planned for this outcome measure
    End point values
    		 Group 1: 1 month to <3 months Group 2: 3 month to <6 months Group 3: 6 month to 12 months
    Number of subjects analysed
    7
    5
    5
    Units: Microgram(s)/millilitre
        arithmetic mean (standard deviation)
    0.69 ( 0.41 )
    0.74 ( 0.17 )
    3.24 ( 1.01 )
    No statistical analyses for this end point

    Primary: Area under the concentration ­time curve (AUC 0­-tlast) of penciclovir

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    End point title
    		 Area under the concentration ­time curve (AUC 0­-tlast) of penciclovir [3]
    End point description
    The area under the concentration ­time curve from time from zero to the last quantifiable concentration-time point (AUC 0-­tlast) was used to measure the total drug exposure over time. The analysis was performed in the PK population. Here, "Number of subjects analysed" signifies those subjects evaluable for AUC (0-tlast) for each arm, respectively.
    End point type
    Primary
    End point timeframe
    30 minutes, 1 hour, 4 hour and 6 hours (Post-dose)
    Notes
    [3] - 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 descriptive summary statistics was planned for this outcome measure
    End point values
    		 Group 1: 1 month to <3 months Group 2: 3 month to <6 months Group 3: 6 month to 12 months
    Number of subjects analysed
    7
    5
    5
    Units: Hour*microgram/millilitre
        arithmetic mean (standard deviation)
    2.09 ( 1.38 )
    3.16 ( 0.68 )
    8.68 ( 2.09 )
    No statistical analyses for this end point

    Primary: Area under the concentration ­time curve from time zero to 6 hours (AUC 0-6h) of penciclovir

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    End point title
    		 Area under the concentration ­time curve from time zero to 6 hours (AUC 0-6h) of penciclovir [4]
    End point description
    The area under the concentration­ time curve from time zero to 6 hours (AUC 0-6h) was used to measure the total drug exposure over 6 hours after dose administration. The analysis was performed in the PK population. Here, "Number of subjects analysed" signifies those subjects evaluable for AUC (0-6h) for each arm, respectively.
    End point type
    Primary
    End point timeframe
    30 minutes, 1 hour, 4 hour and 6 hours (Post-dose)
    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: Only descriptive summary statistics was planned for this outcome measure
    End point values
    		 Group 1: 1 month to <3 months Group 2: 3 month to <6 months Group 3: 6 month to 12 months
    Number of subjects analysed
    7
    5
    5
    Units: Hour*milligram/millilitre
        arithmetic mean (standard deviation)
    2.22 ( 1.23 )
    3.16 ( 0.68 )
    8.77 ( 2.14 )
    No statistical analyses for this end point

    Secondary: Percentage of subjects experiencing tolerability reactions of famciclovir

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    End point title
    		 Percentage of subjects experiencing tolerability reactions of famciclovir
    End point description
    Subjects after dosing with famciclovir were assessed by study personnel using a 4-point scale for tolerability reactions of famciclovir as: 1. Subject with significant emesis 2. Subject spit out most of the dose ingesting less than half of what was administered 3. Subject spit out some of the dose, but ingested at least 50% of what was administered 4. Subject was able to ingest and retain the dose administered. The analysis was performed in the safety (SAF) population defined as all subjects who received any dose (including partial dose) of study drug and had at least one post-baseline safety, tolerability or acceptability assessment.
    End point type
    Secondary
    End point timeframe
    30 minutes (Post-dose)
    End point values
    		 Group 1: 1 month to <3 months Group 2: 3 month to <6 months Group 3: 6 month to 12 months
    Number of subjects analysed
    8
    5
    5
    Units: Percentage of subjects
    number (not applicable)
        Significant emesis occurred
    12.5
    0
    0
        Spit out most of the dose, ingested less than half
    0
    0
    0
        Spit out some of the dose, ingested at least 50 %
    0
    0
    0
        Able to ingest and retain dose
    87.5
    100
    100
    No statistical analyses for this end point

    Secondary: Subjective assessment of acceptability of famciclovir by the caregivers

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    End point title
    		 Subjective assessment of acceptability of famciclovir by the caregivers
    End point description
    Subjects were assessed by caregiver using a 5-point scale for acceptability of famciclovir as: 1. Very badly accepted/unacceptable: subject showed great displeasure, compromising use of formulation, 2. Badly but accepted: subject showed displeasure with dosing but could be coaxed to take complete dose, 3. Neither good nor bad: subject showed no apparent displeasure and with little effort was coaxed to take complete dose, 4. Well accepted: subject appeared to enjoy the formulation and with little coaxing ingested most of dose, and 5. Very well accepted: subject appeared eager and ingested most of dose without special coaxing. The analysis was performed in the SAF population.
    End point type
    Secondary
    End point timeframe
    Immediately after dose administration
    End point values
    		 Group 1: 1 month to <3 months Group 2: 3 month to <6 months Group 3: 6 month to 12 months
    Number of subjects analysed
    8
    5
    5
    Units: Number of subjects
        Very badly / unacceptable
    1
    0
    0
        Badly but accepted
    0
    0
    1
        Neither good nor bad
    0
    2
    1
        Well accepted
    2
    0
    2
        Very well accepted
    4
    3
    1
    No statistical analyses for this end point

    Secondary: Subjective assessment of acceptability of famciclovir by the study personnel

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    End point title
    		 Subjective assessment of acceptability of famciclovir by the study personnel
    End point description
    Subjects were assessed by study personnel using a 5-point scale for acceptability of famciclovir as: 1. Very badly accepted/unacceptable: subject showed great displeasure, compromising use of formulation, 2. Badly but accepted: subject showed displeasure with dosing but could be coaxed to take complete dose, 3. Neither good nor bad: subject showed no apparent displeasure and with little effort was coaxed to take complete dose, 4. Well accepted: subject appeared to enjoy the formulation and with little coaxing ingested most of dose, and 5. Very well accepted: subject appeared eager and ingested most of dose without special coaxing. The analysis was performed in the SAF population.
    End point type
    Secondary
    End point timeframe
    Immediately after dose administration
    End point values
    		 Group 1: 1 month to <3 months Group 2: 3 month to <6 months Group 3: 6 month to 12 months
    Number of subjects analysed
    8
    5
    5
    Units: Number of subjects
        Very badly / unacceptable
    1
    0
    0
        Badly but accepted
    0
    0
    1
        Neither good nor bad
    0
    2
    2
        Well accepted
    2
    0
    1
        Very well accepted
    4
    3
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    		 Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
    End point description
    Adverse events (AEs) are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. The analysis was performed in the SAF population.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 38
    End point values
    		 Group 1: 1 month to <3 months Group 2: 3 month to <6 months Group 3: 6 month to 12 months
    Number of subjects analysed
    8
    5
    5
    Units: Number of subjects
        AEs
    3
    3
    2
        SAEs
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV).  All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    3 to <6 months
    Reporting group description
    		 3 to <6 months

    Reporting group title
    1 to <3 months
    Reporting group description
    		 1 to <3 months

    Reporting group title
    6 to 12 months
    Reporting group description
    		 6 to 12 months

    Serious adverse events
    		 3 to <6 months 1 to <3 months 6 to 12 months
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 3 to <6 months 1 to <3 months 6 to 12 months
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    3 / 8 (37.50%)
    2 / 5 (40.00%)
    Investigations
    Occult blood positive
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Encephalitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    1
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    1
    Diarrhoea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 8 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jun 2007
    Subjects with varicella zoster virus (VZV) infections were removed from the inclusion criteria.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/20160046
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