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    Clinical Trial Results:
    A multicenter, open-label study to evaluate preventive efficacy for herpes simplex virus infection and safety of 256U87 (valaciclovir hydrochloride) in adult and pediatric hematopoietic stem cell transplantation patients

    Summary
    EudraCT number
    		 2015-004869-88
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 May 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jan 2017
    First version publication date
    21 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    116100
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    19 Jul 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To be decided
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 May 2012
    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
    Japan: 40
    Worldwide total number of subjects
    40
    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)
    13
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 40 subjects (21 adults, 19 pediatrics) who gave consent to participate in the study and were confirmed to be eligible for the study during the screening period were enrolled in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet
    Arm description
    		 Adult participants (between 16 and 65 years of age) received a valaciclovir hydrochloride (VACV) tablet containing 500 milligrams (mg) of valaciclovir orally twice daily for 43 days, from 7 days before hematopoietic stem cell transplantation (HSCT) to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
    Arm type
    		 Experimental

    Investigational medicinal product name
    256U87 (VACV) tablets (containing 500 mg of valaciclovir)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Given orally twice daily.

    Arm title
    		 Pediatric participants: VACV 500 mg granules/tablets
    Arm description
    		 Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kilogram (kg) body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
    Arm type
    		 Experimental

    Investigational medicinal product name
    256U87 (VACV) tablets (containing 500 mg of valaciclovir)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Given orally twice daily.

    Investigational medicinal product name
    256U87 (VACV) granules (500 mg of valaciclovir)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Given orally at a dose of 25 mg/kg body weight twice daily

    Number of subjects in period 1
    		Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Started
    21
    19
    Completed
    16
    16
    Not completed
    5
    3
         Physician decision
    1
    1
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adult participants: Valaciclovir hydrochloride 500 mg tablet
    Reporting group description
    		 Adult participants (between 16 and 65 years of age) received a valaciclovir hydrochloride (VACV) tablet containing 500 milligrams (mg) of valaciclovir orally twice daily for 43 days, from 7 days before hematopoietic stem cell transplantation (HSCT) to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).

    Reporting group title
    Pediatric participants: VACV 500 mg granules/tablets
    Reporting group description
    		 Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kilogram (kg) body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).

    Reporting group values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets Total
    Number of subjects
    		 21 19
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 48.6 ( 14.32 ) 7.5 ( 4.69 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 9 7 16
        Male
    		 12 12 24
    Race/Ethnicity, Customized
    Units: Subjects
        Asian - Japanese Heritage
    		 21 19 40

    End points

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    End points reporting groups
    Reporting group title
    Adult participants: Valaciclovir hydrochloride 500 mg tablet
    Reporting group description
    		 Adult participants (between 16 and 65 years of age) received a valaciclovir hydrochloride (VACV) tablet containing 500 milligrams (mg) of valaciclovir orally twice daily for 43 days, from 7 days before hematopoietic stem cell transplantation (HSCT) to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).

    Reporting group title
    Pediatric participants: VACV 500 mg granules/tablets
    Reporting group description
    		 Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kilogram (kg) body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).

    Primary: Number of participants with a herpes simplex virus (HSV) infection

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    End point title
    		 Number of participants with a herpes simplex virus (HSV) infection [1]
    End point description
    Viral isolation/identification was conducted if the investigator (or subinvestigator) suspected HSV infection according to the relevant clinical symptoms (oral mucositis, skin infection, genital herpes, and pneumonia). If the result of viral isolation/identification was positive, the participant concerned was defined as a case of HSV infection. For reference, a virus deoxyribonucleic acid (DNA) identification (PCR) was simultaneously performed. Full Analysis Set (FAS): All participants who were given VACV more than once and who could provide data evaluable with respect to the occurrence of HSV infection. Percentage of participants with a herpes simplex virus infection were zero in the adult participant group and pediatric participant group, with 2-sided 95% confidence interval 0.00-16.11 and 0.00-17.65 respectively.
    End point type
    Primary
    End point timeframe
    From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)
    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: There are no statistical data to report
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [2]
    19 [3]
    Units: Participants
    0
    0
    Notes
    [2] - Full Analysis Set
    [3] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Number of participants with any adverse event (AE) or any serious adverse event (SAE)

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    End point title
    		 Number of participants with any adverse event (AE) or any serious adverse event (SAE)
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
    End point type
    Secondary
    End point timeframe
    From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [4]
    19
    Units: Participants
        Any AE
    13
    11
        Any SAE
    2
    1
    Notes
    [4] - Safety Population: All participants who received VACV more than once .
    No statistical analyses for this end point

    Secondary: Mean alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine phosphokinase (CPK), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LD) values at Screening, Day 14, and Day 35

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    End point title
    		 Mean alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine phosphokinase (CPK), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LD) values at Screening, Day 14, and Day 35
    End point description
    Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35. Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/a t different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.
    End point type
    Secondary
    End point timeframe
    Screening (SCR), Day 14, and Day 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [5]
    19
    Units: International units per liter (IU/L)
    arithmetic mean (standard deviation)
        ALP, SCR, n=21, 19
    247.1 ( 105.09 )
    598.8 ( 132.37 )
        ALP, Day 14, n=18, 17
    358.7 ( 206.04 )
    456.7 ( 206.98 )
        ALP, Day 35, n=16, 16
    314.9 ( 111.65 )
    519.9 ( 183.83 )
        ALT, SCR, n=21, 19
    23.7 ( 10.98 )
    20.7 ( 12.55 )
        ALT, Day 14, n=18, 17
    53.2 ( 63.38 )
    62.1 ( 84.64 )
        ALT, Day 35, n=16, 16
    58.9 ( 36.92 )
    62 ( 76.59 )
        AST, SCR, n=21, 19
    23.2 ( 9.01 )
    27.1 ( 9.62 )
        AST, Day 14, n=18, 17
    39.8 ( 39.82 )
    35 ( 34.88 )
        AST, Day 35, n=16, 16
    45.1 ( 19.12 )
    54 ( 48.96 )
        CPK, SCR, n=21, 19
    65.1 ( 70.37 )
    72 ( 40.63 )
        CPK, Day 14, n=18, 17
    20.5 ( 9.88 )
    27.4 ( 28.85 )
        CPK, Day 35, n=16, 16
    42.1 ( 26.74 )
    38.4 ( 26.48 )
        GGT, SCR, n=21, 19
    47.2 ( 34.94 )
    24.8 ( 24.74 )
        GGT, Day 14, n=18, 17
    118.4 ( 113.63 )
    27.5 ( 10.61 )
        GGT, Day 35, n=16, 16
    90.3 ( 70.96 )
    50.7 ( 43.34 )
        LD, SCR, n=21, 19
    251.8 ( 179.06 )
    213.3 ( 77.51 )
        LD, Day 14, n=18, 17
    215.4 ( 68.15 )
    210.6 ( 103.09 )
        LD, Day 35, n=16, 16
    256.7 ( 65.92 )
    255.9 ( 92.84 )
    Notes
    [5] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean direct bilirubin, total bilirubin, creatinine, and uric acid values at Screening, Day 14, and Day 35

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    End point title
    		 Mean direct bilirubin, total bilirubin, creatinine, and uric acid values at Screening, Day 14, and Day 35
    End point description
    Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine, and uric acid at Screening, Day 14, and Day 35.
    End point type
    Secondary
    End point timeframe
    Screening (SCR), Day 14, and Day 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [6]
    19
    Units: Micromoles per liter (µmol/L)
    arithmetic mean (standard deviation)
        Direct bilirubin, SCR, n=21, 19
    2.931 ( 1.8843 )
    2.97 ( 1.8769 )
        Direct bilirubin, Day 14, n=18, 17
    7.41 ( 11.5234 )
    3.923 ( 3.0688 )
        Direct bilirubin, Day 35, n=16, 16
    2.351 ( 0.855 )
    2.565 ( 1.2488 )
        Total bilirubin, SCR, n=21, 19
    8.224 ( 5.4242 )
    8.19 ( 3.9728 )
        Total bilirubin, Day 14, n=18, 17
    12.54 ( 14.8264 )
    9.858 ( 8.6251 )
        Total bilirubin, Day 35, n=16, 16
    6.306 ( 1.9466 )
    6.733 ( 3.1512 )
        Creatinine, SCR, n=21, 19
    62.6798 ( 19.71123 )
    30.1025 ( 10.12416 )
        Creatinine, Day 14, n=18, 17
    46.7047 ( 16.31214 )
    25.532 ( 12.84039 )
        Creatinine, Day 35, n=16, 16
    58.786 ( 18.8301 )
    33.371 ( 19.49749 )
        Uric acid, SCR, n=21, 19
    276.1571 ( 80.38764 )
    259.5206 ( 63.88405 )
        Uric acid, Day 14, n=18, 17
    133.1691 ( 62.35442 )
    137.5038 ( 56.34464 )
        Uric acid, Day 35, n=16, 16
    255.0205 ( 96.37167 )
    238.6635 ( 101.474 )
    Notes
    [6] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean cholesterol, chloride, glucose, potassium, sodium, triglyceride, and urea/blood urea nitrogen (BUN) values at Screening, Day 14, and Day 35

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    End point title
    		 Mean cholesterol, chloride, glucose, potassium, sodium, triglyceride, and urea/blood urea nitrogen (BUN) values at Screening, Day 14, and Day 35
    End point description
    Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35.
    End point type
    Secondary
    End point timeframe
    Screening (SCR), Day 14, and Day 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [7]
    19
    Units: Millimoles per liter (mmol/L)
    arithmetic mean (standard deviation)
        Cholesterol, SCR, n=21, 19
    4.8149 ( 1.33518 )
    4.1703 ( 0.70625 )
        Cholesterol, Day 14, n=18, 17
    4.0255 ( 1.06483 )
    3.5504 ( 1.2561 )
        Cholesterol, Day 35, n=16, 16
    5.5324 ( 1.45536 )
    4.1279 ( 1.01828 )
        Chloride, SCR, n=21, 19
    105.2 ( 2.83 )
    103.3 ( 2.21 )
        Chloride, Day 14, n=18, 17
    104.4 ( 4.06 )
    105 ( 2.06 )
        Chloride, Day 35, n=16, 16
    106 ( 2.99 )
    104 ( 2.31 )
        Glucose, SCR, n=21, 19
    5.8127 ( 1.38621 )
    6.0214 ( 1.83355 )
        Glucose, Day 14, n=18, 17
    7.2656 ( 2.31056 )
    6.0996 ( 2.13721 )
        Glucose, Day 35, n=16, 16
    6.4808 ( 1.3516 )
    5.78 ( 1.41869 )
        Potassium, SCR, n=21, 19
    4.08 ( 0.402 )
    4.01 ( 0.283 )
        Potassium, Day 14, n=18, 17
    3.93 ( 0.457 )
    4.34 ( 0.449 )
        Potassium, Day 35, n=16, 16
    4.31 ( 0.521 )
    4.09 ( 0.359 )
        Sodium, SCR, n=21, 19
    142 ( 1.92 )
    140.2 ( 1.92 )
        Sodium, Day 14, n=18, 17
    140.3 ( 4.16 )
    139.2 ( 1.55 )
        Sodium, Day 35, n=16, 16
    141.8 ( 2.29 )
    139.3 ( 1.39 )
        Triglycerides, SCR, n=21, 19
    2.076 ( 1.30955 )
    1.3489 ( 0.75044 )
        Triglycerides, Day 14, n=18, 17
    1.8789 ( 0.95581 )
    1.4185 ( 1.02762 )
        Triglycerides, Day 35, n=16, 16
    2.9486 ( 1.49324 )
    1.6646 ( 1.04585 )
        Urea/BUN, SCR, n=21, 19
    4.2721 ( 1.61486 )
    3.6903 ( 0.93331 )
        Urea/BUN, Day 14, n=18, 17
    4.8274 ( 3.76473 )
    3.1332 ( 1.35997 )
        Urea/BUN, Day 35, n=16, 16
    3.7619 ( 1.72437 )
    4.1657 ( 1.99412 )
    Notes
    [7] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean albumin and total protein values at Screening, Day 14, and Day 35

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    End point title
    		 Mean albumin and total protein values at Screening, Day 14, and Day 35
    End point description
    Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35.
    End point type
    Secondary
    End point timeframe
    Screening (SCR), Day 14, and Day 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [8]
    19
    Units: Grams per liter (G/L)
    arithmetic mean (standard deviation)
        Albumin, SCR, n=21, 19
    41 ( 3.07 )
    41.5 ( 2.04 )
        Albumin, Day 14, n=18, 17
    34.6 ( 3.87 )
    39.1 ( 3.04 )
        Albumin, Day 35, n=16, 16
    40.8 ( 3.34 )
    40.9 ( 3.02 )
        Total protein, SCR, n=21, 19
    64.2 ( 5.83 )
    66.2 ( 5.34 )
        Total protein, Day 14, n=18, 17
    57.6 ( 5.76 )
    62.7 ( 5.08 )
        Total protein, Day 35, n=16, 16
    62.9 ( 4.75 )
    65.3 ( 5.84 )
    Notes
    [8] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean basophil, eosinophil, lymphocyte, monocyte, and total neutrophil values at Screening, Day 14, and Day 35

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    End point title
    		 Mean basophil, eosinophil, lymphocyte, monocyte, and total neutrophil values at Screening, Day 14, and Day 35
    End point description
    Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Screening, Day 14, and Day 35.
    End point type
    Secondary
    End point timeframe
    Screening (SCR), Day 14, and Day 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [9]
    19
    Units: Percentage of cells in blood
    arithmetic mean (standard deviation)
        Basophils, SCR, n=21,19
    1.05 ( 1.473 )
    0.49 ( 0.47 )
        Basophils, Day 14, n=16, 16
    0.69 ( 1.661 )
    0.14 ( 0.352 )
        Basophils, Day 35, n=16, 15
    1.09 ( 0.903 )
    0.59 ( 0.38 )
        Eosinophils, SCR, n=21, 19
    3.67 ( 4.754 )
    2.06 ( 1.974 )
        Eosinophils, Day 14, n=16, 16
    0.79 ( 2.77 )
    0.59 ( 1.517 )
        Eosinophils, Day 35, n=16, 15
    4.1 ( 2.672 )
    7.51 ( 10.357 )
        Lymphocytes, SCR, n=21,19
    32.72 ( 16.104 )
    38.94 ( 21.616 )
        Lymphocytes, Day 14, n=16, 16
    13.61 ( 8.897 )
    16.73 ( 17.909 )
        Lymphocytes, Day 35, n=16, 15
    37.08 ( 15.496 )
    30.85 ( 20.338 )
        Monocytes, SCR, n=21,19
    7.9 ( 3.337 )
    10.99 ( 7.565 )
        Monocytes, Day 14, n=16, 16
    15.32 ( 7.263 )
    17.33 ( 12.061 )
        Monocytes, Day 35, n=16, 15
    14.54 ( 6.609 )
    13.33 ( 7.021 )
        Total neutrophils, SCR, n=21,19
    54.46 ( 15.003 )
    47.52 ( 22.667 )
        Total neutrophils, Day 14, n=16, 16
    63.53 ( 18.117 )
    62.21 ( 23.273 )
        Total neutrophils, Day 35, n=16, 15
    42.76 ( 13.336 )
    47.63 ( 20.745 )
    Notes
    [9] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean platelet count and white blood cell (WBC) count at Screening, Day 14, and Day 35

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    End point title
    		 Mean platelet count and white blood cell (WBC) count at Screening, Day 14, and Day 35
    End point description
    Blood samples were collected for the measurement of platelet count and WBC count at Screening, Day 14, and Day 35.
    End point type
    Secondary
    End point timeframe
    Screening (SCR), Day 14, and Day 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [10]
    19
    Units: giga (10^9) per liter (GI/L)
    arithmetic mean (standard deviation)
        Platelet count, SCR, n=21,19
    190.2 ( 126.32 )
    167.7 ( 98.15 )
        Platelet count, Day 14, n=18, 17
    40.3 ( 20.73 )
    58.2 ( 37.41 )
        Platelet count, Day 35, n=16, 16
    139.4 ( 79.29 )
    119 ( 89.31 )
        WBC count, SCR, n=21,19
    4.01 ( 1.842 )
    3.03 ( 1.873 )
        WBC count, Day 14, n=16, 12
    3.46 ( 2.955 )
    2.23 ( 2.403 )
        WBC count, Day 35, n=16, 14
    5 ( 3.524 )
    3.71 ( 2.189 )
    Notes
    [10] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean red blood cell count at Screening, Day 14, and Day 35

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    End point title
    		 Mean red blood cell count at Screening, Day 14, and Day 35
    End point description
    Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35.
    End point type
    Secondary
    End point timeframe
    Screening (SCR), Day 14, and Day 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [11]
    19
    Units: tera (10^12) per liter (TI/L)
    arithmetic mean (standard deviation)
        SCR, n=21,19
    3.165 ( 0.7583 )
    3.293 ( 0.6529 )
        Day 14, n=18, 17
    2.932 ( 0.3479 )
    2.908 ( 0.3854 )
        Day 35, n=16, 16
    3.297 ( 0.5021 )
    3.073 ( 0.4797 )
    Notes
    [11] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean hemoglobin values at Screening, Day 14, and Day 35

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    End point title
    		 Mean hemoglobin values at Screening, Day 14, and Day 35
    End point description
    Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35.
    End point type
    Secondary
    End point timeframe
    Screening (SCR), Day 14, and Day 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [12]
    19 [13]
    Units: Grams per liter (G/L)
    arithmetic mean (standard deviation)
        SCR, n=21,19
    101.6 ( 24.84 )
    99.3 ( 17.94 )
        Day 14, n=18, 17
    91.6 ( 10.02 )
    85.1 ( 12.1 )
        Day 35, n=16, 16
    106.5 ( 16.36 )
    94.4 ( 15.23 )
    Notes
    [12] - Safety Population.
    [13] - Safety Population.
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated result for the indicated urinalysis parameters tested by dipstick at Screening, Day 14, and Day 35

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    End point title
    		 Number of participants with the indicated result for the indicated urinalysis parameters tested by dipstick at Screening, Day 14, and Day 35
    End point description
    Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), urine protein (UP), and urine urobilinogen (UUG). The dipstick is a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, and 3+ (in order of increasing levels). Data are reported as the number of participants who had Neg, Trace, 1+, 2+, and 3+ levels at Screening, Day 14, and Day 35. If a category has not been reported for a specific parameter, then no participants were measured in that category.
    End point type
    Secondary
    End point timeframe
    Screening (SCR), Day 14, and 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [14]
    19 [15]
    Units: Participants
        UB, Neg, SCR, n=21, 19
    21
    19
        UB, Neg, Day 14, n=18, 17
    18
    17
        UB, Neg, Day 35, n=16, 16
    16
    16
        UOB, Neg, SCR, n=21, 19
    19
    19
        UOB, 2+, SCR, n=21, 19
    2
    0
        UOB, Neg, Day 14, n=18, 17
    14
    14
        UOB, Trace, Day 14, n=18, 17
    2
    2
        UOB, 1+, Day 14, n=18, 17
    2
    0
        UOB, 3+, Day 14, n=18, 17
    0
    1
        UOB, Neg, Day 35, n=16, 16
    12
    16
        UOB, Trace, Day 35, n=16, 16
    1
    0
        UOB, 1+, Day 35, n=16, 16
    2
    0
        UOB, 3+, Day 35, n=16, 16
    1
    0
        UG, Neg, SCR, n=21, 19
    19
    19
        UG, Trace, SCR, n=21, 19
    2
    0
        UG, Neg, Day 14, n=18, 17
    14
    17
        UG, Trace, Day 14, n=18, 17
    1
    0
        UG, 1+, Day 14, n=18, 17
    1
    0
        UG, 2+, Day 14, n=18, 17
    1
    0
        UG, 3+, Day 14, n=18, 17
    1
    0
        UG, Neg, Day 35, n=16, 16
    15
    16
        UG, Trace, Day 35, n=16, 16
    1
    0
        UK, Neg, SCR, n=21, 19
    21
    19
        UK, Neg, Day 14, n=18, 17
    17
    17
        UK, 1+, Day 14, n=18, 17
    1
    0
        UK, Neg, Day 35, n=16, 16
    16
    15
        UK, 1+, Day 35, n=16, 16
    0
    1
        UP, Neg, SCR, n=21, 19
    19
    14
        UP, Trace, SCR, n=21, 19
    0
    4
        UP, 1+, SCR, n=21, 19
    0
    1
        UP, 2+, SCR, n=21, 19
    2
    0
        UP, Neg, Day 14, n=18, 17
    9
    12
        UP, Trace, Day 14, n=18, 17
    5
    4
        UP, 1+, Day 14, n=18, 17
    2
    0
        UP, 2+, Day 14, n=18, 17
    2
    1
        UP, Neg, Day 35, n=16, 16
    13
    13
        UP, Trace, Day 35, n=16, 16
    2
    1
        UP, 1+, Day 35, n=16, 16
    1
    2
        UUG, Trace, SCR, n=21, 19
    19
    19
        UUG, 2+, SCR, n=21, 19
    2
    0
        UUG, Trace, Day 14, n=18, 17
    17
    15
        UUG, 1+, Day 14, n=18, 17
    1
    0
        UUG, 2+, Day 14, n=18, 17
    0
    1
        UUG, 3+, Day 14, n=18, 17
    0
    1
        UUG, Trace, Day 35, n=16, 16
    16
    15
        UUG, 3+, Day 35, n=16, 16
    0
    1
    Notes
    [14] - Safety Population
    [15] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean urine specific gravity values at Screening, Day 14, and Day 35

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    End point title
    		 Mean urine specific gravity values at Screening, Day 14, and Day 35
    End point description
    Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.
    End point type
    Secondary
    End point timeframe
    Screening (SCR), Day 14, and Day 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [16]
    19
    Units: ratio
    arithmetic mean (standard deviation)
        SCR, n=21, 19
    1.0146 ( 0.00705 )
    1.0188 ( 0.00912 )
        Day 14, n=18, 17
    1.0158 ( 0.00628 )
    1.0155 ( 0.00685 )
        Day 35, n=16, 16
    1.0137 ( 0.00572 )
    1.0153 ( 0.00642 )
    Notes
    [16] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in systolic blood pressure and diastolic blood pressure at Days 0, 7, 14, 21, and 35

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    End point title
    		 Change from Baseline in systolic blood pressure and diastolic blood pressure at Days 0, 7, 14, 21, and 35
    End point description
    Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline; Days 0, 7, 14, 21, and 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [17]
    19
    Units: Millimeters of mercury
    arithmetic mean (standard deviation)
        SBP, Day 0, n=21, 19
    -1.8 ( 18.23 )
    -4.7 ( 16.85 )
        SBP, Day 7, n=19, 17
    0.9 ( 18.88 )
    -6.1 ( 16.34 )
        SBP, Day 14, n=18, 17
    4.3 ( 20.68 )
    -7.6 ( 18.61 )
        SBP, Day 21, n=17, 17
    -1.4 ( 14.98 )
    -7 ( 13.88 )
        SBP, Day 35, n=16, 16
    2.8 ( 20.14 )
    -4.5 ( 15.08 )
        DBP, Day 0, n=21, 19
    -2.7 ( 16.04 )
    -1.8 ( 13.63 )
        DBP, Day 7, n=19, 17
    1.6 ( 16.37 )
    0.3 ( 13.87 )
        DBP, Day 14, n=18, 17
    3.4 ( 18.29 )
    -5.9 ( 14.69 )
        DBP, Day 21, n=17, 17
    1.5 ( 11.41 )
    -1.2 ( 11.91 )
        DBP, Day 35, n=16, 16
    4.7 ( 14.74 )
    -1.1 ( 11.2 )
    Notes
    [17] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in heart rate at Days 0, 7, 14, 21, and 35

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    End point title
    		 Change from Baseline in heart rate at Days 0, 7, 14, 21, and 35
    End point description
    Heart rate is defined as the number of heartbeats per unit of time. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline; Days 0, 7, 14, 21, and 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [18]
    19
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Day 0, n=21, 19
    1.1 ( 13.66 )
    -1 ( 17.15 )
        Day 7, n=19, 17
    13.3 ( 14.41 )
    3.8 ( 20.42 )
        Day 14, n=18, 17
    12.5 ( 14.7 )
    3.6 ( 25.47 )
        Day 21, n=17, 17
    16.4 ( 14.54 )
    1.8 ( 21.14 )
        Day 35, n=16, 16
    19.2 ( 18.99 )
    3.6 ( 23.6 )
    Notes
    [18] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated electrocardiogram (ECG) findings at Screening and Day 35

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    End point title
    		 Number of participants with the indicated electrocardiogram (ECG) findings at Screening and Day 35
    End point description
    The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening and Day 35 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.
    End point type
    Secondary
    End point timeframe
    Screening (SCR) and Day 35
    End point values
    		 Adult participants: Valaciclovir hydrochloride 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Number of subjects analysed
    21 [19]
    19
    Units: Participants
        SCR, Normal, n=21, 19
    16
    19
        SCR, NCS, n=21, 19
    5
    0
        SCR, CS, n=21, 19
    0
    0
        SCR, NR, n=21, 19
    0
    0
        Day 35, Normal, n=16, 16
    15
    13
        Day 35, NCS, n=16, 16
    1
    2
        Day 35, CS, n=16, 16
    0
    0
        Day 35, NR, n=16, 16
    0
    1
    Notes
    [19] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until the end of the treatment (up to Day 43).
    Adverse event reporting additional description
    SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received VACV more than once.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Adult participants: VACV 500 mg tablet
    Reporting group description
    		 Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).

    Reporting group title
    Pediatric participants: VACV 500 mg granules/tablets
    Reporting group description
    		 Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).

    Serious adverse events
    		 Adult participants: VACV 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Hepatobiliary disorders
    Liver Injury
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lung disorder
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Toxic skin eruption
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adult participants: VACV 500 mg tablet Pediatric participants: VACV 500 mg granules/tablets
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 21 (47.62%)
    8 / 19 (42.11%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 21 (4.76%)
    4 / 19 (21.05%)
         occurrences all number
    1
    6
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 21 (4.76%)
    4 / 19 (21.05%)
         occurrences all number
    1
    5
    Amylase increased
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    4
    C-reactive protein increased
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    Blood bilirubin increased
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
         occurrences all number
    2
    1
    Blood urine present
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Occult blood
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 19 (10.53%)
         occurrences all number
    2
    3
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    3 / 21 (14.29%)
    4 / 19 (21.05%)
         occurrences all number
    3
    4
    Anaemia
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 19 (15.79%)
         occurrences all number
    3
    3
    Febrile neutropenia
         subjects affected / exposed
    6 / 21 (28.57%)
    0 / 19 (0.00%)
         occurrences all number
    6
    0
    Leukopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    4 / 19 (21.05%)
         occurrences all number
    0
    4
    Neutropenia
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    Lymphopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 21 (23.81%)
    2 / 19 (10.53%)
         occurrences all number
    5
    2
    Pyrexia
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 19 (15.79%)
         occurrences all number
    2
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 21 (38.10%)
    4 / 19 (21.05%)
         occurrences all number
    9
    6
    Vomiting
         subjects affected / exposed
    3 / 21 (14.29%)
    5 / 19 (26.32%)
         occurrences all number
    3
    6
    Stomatitis
         subjects affected / exposed
    4 / 21 (19.05%)
    2 / 19 (10.53%)
         occurrences all number
    4
    2
    Nausea
         subjects affected / exposed
    5 / 21 (23.81%)
    3 / 19 (15.79%)
         occurrences all number
    5
    3
    Abdominal pain
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 19 (15.79%)
         occurrences all number
    2
    3
    Constipation
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 19 (15.79%)
         occurrences all number
    2
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Proctalgia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Tongue coated
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 19 (10.53%)
         occurrences all number
    3
    2
    Oropharyngeal pain
         subjects affected / exposed
    4 / 21 (19.05%)
    1 / 19 (5.26%)
         occurrences all number
    4
    1
    Cough
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 19 (5.26%)
         occurrences all number
    3
    1
    Alopecia
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Urticaria
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Pruritus
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 19 (0.00%)
         occurrences all number
    4
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 19 (0.00%)
         occurrences all number
    4
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Bacteraemia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    7 / 21 (33.33%)
    2 / 19 (10.53%)
         occurrences all number
    7
    2
    Fluid retention
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    Hyperglycaemia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Hypomagnesaemia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0

    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.
    None reported
    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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