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    Summary
    EudraCT Number:2013-001332-22
    Sponsor's Protocol Code Number:RG_12-201
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-31
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-001332-22
    A.3Full title of the trial
    PEPtalk 2: Pilot of a randomised controlled trial to compare VZIG and
    aciclovir as post-exposure prophylaxis against chickenpox in children with
    cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PEPtalk2
    A.3.2Name or abbreviated title of the trial where available
    PEPtalk 2
    A.4.1Sponsor's protocol code numberRG_12-201
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN48257441
    A.5.4Other Identifiers
    Name:CAS CodeNumber:XX2001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Birmingham
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR Research for Patient Benefit
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointTrial Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressCRCTU CRUK
    B.5.3.2Town/ cityVincent Drive, Edgbaston
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0121 415 8211
    B.5.5Fax number0121 414 9520
    B.5.6E-mailPEPtalk2@trials.bham.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHuman Varicella-Zoster Immunoglobulin
    D.3.2Product code VZIG
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhuman varicella-zoster immunoglobulin
    D.3.9.3Other descriptive nameVZIG
    D.3.9.4EV Substance CodeAS12
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250mg to 1000mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAciclovir
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNaciclovir
    D.3.9.4EV Substance CodeAS13
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200mg/5ml to 800mg/5ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAciclovir
    D.3.4Pharmaceutical form Dispersible tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNaciclovir
    D.3.9.4EV Substance CodeAS14
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200mg to 800mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Exposure to Varicella by children who have cancer.
    E.1.1.1Medical condition in easily understood language
    Exposure to chickenpox by children who have cancer.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10046980
    E.1.2Term Varicella
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this pilot trial is to establish the likely rate of patient recruitment in a projected full-scale Phase III trial and to gather data which will allow for an informed sample size calculation for the main trial.

    This will enable a full-scale trial to compare the efficacy, safety and acceptability of varicella zoster immunoglobulin (VZIG) and aciclovir as post-exposure prophylaxis (PEP) for chickenpox in children receiving treatment for cancer. This would address the urgent need for evidence on how best to prevent chickenpox in children receiving treatment for cancer who are exposed to the virus. The proposed definitive study will be a multi-centre randomised controlled trial to compare aciclovir with VZIG.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the pilot study are
    • To create interest in and support for the study among paediatric oncologists
    • To identify the most important costs and health-related quality of life implications and define the data to be collected for the assessment of the cost-effectiveness in a subsequent Phase III trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For Registration:
    a) Under 16 years of age.
    b) EITHER diagnosed with cancer such that there is a standard expectation of
    immunocompromising therapy
    OR currently receiving immunocompromising treatment for cancer
    OR within 6 months (180 days) of having received immunocompromising treatment for
    cancer.
    c) No current or previous allogeneic or autologous haemopoietic stem cell
    transplantation / rescue.
    d) Negative VZV serostatus result at cancer diagnosis or negative VZV
    serostatus result within the last 3 months as assessed locally.
    e) Written informed consent to registration received from parent/legal
    representative and, where appropriate, written patient assent.

    For randomisation:
    a) Patient has previously been registered in the PEPtalk2 trial, having
    satisfied all registration requirements.
    b) Registration criterion (c) continues to apply.
    c) Immunocompromising treatment for cancer must have been initiated prior to
    VZV exposure.
    d) Patient is able to commence either VZIG no more than 10 days after
    experiencing VZV exposure, or aciclovir at 7 days after experiencing VZV
    exposure (see sections 5.1.2 and 5.1.3).
    e) No renal impairment. Renal impairment is expressed in terms of glomerular
    filtration rate (ml/min/1.73m2).
    Child over 1 year: Estimated glomerular filtration rate (ml/min/1.73m2) =
    40 x height (cm) x serum creatinine (micromol/litre).
    Normal renal function: > or equal to 90ml/min/1.73m2.
    f) Written informed consent to randomisation received from parent/legal
    representative and, where appropriate, written patient assent.

    Important note regarding thrombocytopenia: platelets must be > 50 x 109/L to receive an intramuscular injection of VZIG. Therefore, if a child is randomised to receive VZIG and platelets are found to be < 50 x 109/L no more than 48 hours prior to VZIG administration, arrangements must be made by local staff to administer a platelet transfusion prior to VZIG injection. There are no criteria for platelet count if randomised to aciclovir.
    E.4Principal exclusion criteria
    Exclusion from Registration:
    a) 16 years of age or over.
    b) Current or previous allogeneic or autologous haemopoietic stem cell
    transplant/rescue.
    c) Positive VZV serostatus result as assessed locally within the last 3 months.

    Note: renal impairment and thrombocytopenia are not absolute contraindications for registration as they might resolve by the time a chickenpox exposure and screening for randomisation occur.

    Exclusion from randomisation:
    a) Positive VZV serostatus result at time of screening.
    b) Contraindication to either aciclovir or VZIG, including –
    (i) thrombocytopenia (platelets < 50 x 109/L) that has not been corrected by
    platelet transfusion;
    (ii) renal impairment (exclude any child with GFR below 90ml/min/1.73m2);
    (iii) any other contraindications deemed to be relevant by the local Investigator
    or the Sponsor’s Clinical Coordinator(s).
    c) Inability to start either VZIG within 10 days of VZV exposure, or aciclovir
    at 7 days after VZV exposure.
    d) More than one VZV exposure within the past 12 weeks.
    e) Inability to tolerate medications via oral or enteral route.
    f) Pregnancy or lactation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure will be the number of patients randomised within 12 months of the trial opening to recruitment. Considered in relation to the number of patients registered and the number of patients screened, this will allow an informed evaluation of the trial enrolment rate amongst eligible patients. Data will therefore be collected on patients screened for the study at each centre and the number of eligible patients at each centre who agree to registration and to randomisation.

    In addition to the rate of enrolment, the following guidelines will also inform the design of the main study:

    • compliance with allocated treatment;
    • adherence to study follow up;
    • acceptability of study procedures to patients and clinicians;
    • proportion of scheduled quality of life surveys completed;
    • proportion of patients for whom health care resource use and caregiver
    costs are collected.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The end of trial will be 5 months after last randomisation. This will allow sufficient time for the completion of protocol procedures, data collection and data input.

    Trial data will then be analysed within 6 months of the LVLS.
    E.5.2Secondary end point(s)
    To gauge the acceptability of randomisation and intervention with either VZIG or aciclovir to proposed participants and their families and to estimate likely attrition rates
     To describe any symptomatic varicella occurring in trial participants within 12 (+/-2) weeks of either study intervention (VZIG or aciclovir)
     To describe details of the VZV exposure occurring in trial participants
     To assess varicella seroconversion at 12 (+/-2) weeks after PEP administration
     To provide data on which to estimate the required sample size for the full-scale trial
     To measure standardised health outcomes in trial participants who receive PEP and in those who develop varicella
     To collect information about costs and benefits of either study intervention to inform the assessment of cost-effectiveness in a subsequent Phase III trial
     To gauge acceptability of randomisation and intervention to paediatric oncologists
     To create interest in and support for the study among the study among relevant stakeholders including patients, families and healthcare teams
    E.5.2.1Timepoint(s) of evaluation of this end point
    The end of trial will be 5 months after last randomisation. This will allow sufficient time for the completion of protocol procedures, data collection and data input.

    Trial data will then be analysed within 6 months of the LVLS.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of trial will be 5 months after last randomisation. This will allow sufficient time for the completion of protocol procedures, data collection and data input.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days23
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 50
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There is no clinical requirement for continued provision of this trial intervention.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-30
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