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    Summary
    EudraCT Number:2012-001970-28
    Sponsor's Protocol Code Number:CMV-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-10-10
    Trial 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 number2012-001970-28
    A.3Full title of the trial
    Does CMV reactivation cause functional impairment of CMV specific CD4+ T-cells? The potential for valaciclovir to prevent CMV-mediated adverse modulation of the immune system in patients with ANCA-associated vasculitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does cytomegalovirus affect the function of the body’s immune cells? The potential for anti-viral treatment to prevent the negative effects of cytomegalovirus on the immune system in patients with vasculitis
    A.3.2Name or abbreviated title of the trial where available
    CMV modulation of the immune system in ANCA-associated vasculitis - v1
    A.4.1Sponsor's protocol code numberCMV-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01633476
    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.1.3.4CountryUnited Kingdom
    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 supportWellcome Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportVasculitis UK
    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 pointProfessor Lorraine Harper
    B.5.3 Address:
    B.5.3.1Street AddressSchool of Immunity and Infection, University of Birmingham Research Laboratories
    B.5.3.2Town/ cityBirmimngham
    B.5.3.3Post codeB15 2WB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01213713238
    B.5.6E-maill.harper@bham.ac.uk
    D. IMP Identification
    D.IMP: 1
    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 Yes
    D.2.1.1.1Trade name VALACICLOVIR 500 MG FILMCOATED TABLETS
    D.2.1.1.2Name of the Marketing Authorisation holderRanbaxy (UK) Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameValaciclovir hydrochloride
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    This study will investigate the modulation of the immune system by Cytomegalovirus (CMV) in ANCA-associated vasculitis.

    Specifically the study will investigate the potential for valaciclovir to prevent CMV-mediated adverse modulation of the immune system in patients with ANCA-associated vasculitis.
    E.1.1.1Medical condition in easily understood language
    This study will investigate the potential for antiviral treatment to prevent the negative effects of Cytomegalovirus (CMV) on the immune system in patients with vasculitis.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10011831
    E.1.2Term Cytomegalovirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10050894
    E.1.2Term Anti-neutrophil cytoplasmic antibody positive vasculitis
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Aim 1
    To investigate the association between CMV reactivation and the impairment of the function of CMV committed T-cells in ANCA associated vasculitis

    Aim 2
    To determine whether treatment of ANCA associated vasculitis patients with valaciclovir leads to a reduction in CMV reactivation and improved function of CMV committed T-cells
    E.2.2Secondary objectives of the trial
    Safety of valaciclovir treatment in ANCA associated vasculitis.

    Effects of CMV on the immune system in patients with ANCA associated vasculitis patients.

    Effects of valaciclovir on the immune response in ANCA associated vasculitis patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Documented diagnosis of ANCA associated vasculitis
    • In stable remission (no documented clinical disease activity) for at least 6 months prior to entry.
    • On maintenance immunosuppression with maximum 2 agents.
    • Documented evidence of CMV infection.
    • Documentation that female patients of child bearing age are not pregnant.
    • Written informed consent for study participation
    E.4Principal exclusion criteria
    • Severe chronic kidney disease (Stage 5).
    • Other significant chronic infection (HIV, HBV, HCV, TB).
    • B-cell or T-cell depleting therapy within 12 months.
    • Treatment with anti-CMV therapies in last month
    • Underlying medical conditions, which in the opinion of the Investigator place the patient at unacceptably high risk for participating in the study.
    • Inability to fully or appropriately participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of patients with CMV reactivation, as assessed by measurable viral load on quantitative blood or urine CMV testing by PCR technique.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary timepoint
    At end of 6-month treatment with valaciclovir.

    Secondary timepoint
    At 6 months follow up post cessation of treatment with valaciclovir.
    E.5.2Secondary end point(s)
    • Safety as defined by side effects sufficient to stop treatment with trial drugs or serious adverse events and suspected
    unexpected serious adverse reactions (SUSARs).
    • Change in the immune characteristics of the CMV 'committed' T cell population
    • Change in markers of inflammation in the blood
    • Persistence of valaciclovir effect on immune characteristics of T cells
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary timepoint
    At end of 6-month treatment with valaciclovir.

    Secondary timepoint
    At 6 months follow up post cessation of treatment with valaciclovir.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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 No
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No additional treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 No
    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 No
    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)
    Patients will receive normal standard of care for vasculitis at the end of the trial.

    At present there is no proven long-term benefit for patients to receive valaciclovir.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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