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    The EU Clinical Trials Register currently displays   44138   clinical trials with a EudraCT protocol, of which   7324   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-005508-14
    Sponsor's Protocol Code Number:08/0171
    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:2010-03-15
    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 number2008-005508-14
    A.3Full title of the trial
    A phase 3 randomized, placebo-controlled blinded investigation of six weeks vs. six months of oral valgancoclovir therapy in infants with symtomatic congenital cytomegalovirus infection. DMID # 06-0046 (CASG 112)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A six weeks versus six months Study of oral valgancoclovir medicine and dummy medicine in infants with congenital cytomegalovirus infection symtoms.
    A.3.2Name or abbreviated title of the trial where available
    CASG 112
    A.4.1Sponsor's protocol code number08/0171
    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 College london
    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 supportNational Institute of Allergy and Infectious diseases of the National Institutes of Health
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnivesity College London
    B.5.2Functional name of contact pointProfessor Paul Griffiths
    B.5.3 Address:
    B.5.3.1Street AddressDivision of Infection, Centre for Virology, Royal Free Hosptial, Rowland Hill St
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW3 2PF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402078302997
    B.5.5Fax number004402078302854
    B.5.6E-mailp.griffiths@medsch.ucl.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 Valcyte 50 mg/ml Powder for Oral Solution
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City. AL7 1TW. United Kingdom.
    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 nameValganciclovir
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPNasogastric use (Noncurrent)
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVALGANCICLOVIR HYDROCHLORIDE
    D.3.9.1CAS number 175865-59-5
    D.3.9.2Current sponsor code08/0171
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatic Congenital Cytomegalovirus.
    E.1.1.1Medical condition in easily understood language
    Viral infection before birth
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10010430
    E.1.2Term Congenital cytomegalovirus infection
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether six months of antiviral treatment with oral valganciclovir improves hearing outcome in infants with symptomatic congenital CMV disease compared to six weeks.
    E.2.2Secondary objectives of the trial
    To compare the safety profile of six weeks vs six months of antiviral therapy with valganciclovir oral solution in infants with symptomatic congenital CMV.
    To compare the impact on neurologic outcomes of six weeks versus six months of antiviral treatment with valganciclovir oral solution in infants with symtomatic congenital CMV disease.
    To correlate change in amount of virus in blood with hearing and neurologic outcomes.
    To further assess how valganciclovir drug acts in babies and assess how well babies tolerate treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    1. Signed informed consent from parent(S) or legal guardian (s)
    2. Confirmation of CMV from urine or throat swab specimend by culture, shell vial, or PCR tests
    3. Symptomatic congenital CMV disease, as manifest by one or more of the following:
    Thrombocytopenia,
    Petechiae,
    Hepatomegaly,
    Splenomegaly,
    Intrauterine growth restriction,
    Hepatitis (elevated transaminases and/or bilirubin),
    Central nervous system involvement of CMV disease (such as microcephaly), radiographic abnormalities indicative of CMV Central Nervous system disease, abnormal Cerebral Spinal Fluid (CSF) indices for age, chorioretinitis, hearing deficits as detected by formal brainstem evoked response (not a screening ABR), and/or a positive CMV PCR from CSF.
    4. Less than or equal to 30 days of age at study enrollment
    5. Weight at study enrollment greater than or equal to 1800 grams
    6. Gestational age greater than or equal to 32 weeks at birth
    E.4Principal exclusion criteria
    Exclusion Criteria:
    1. Imminent demise
    2. Patients recieving other antiviral agents or immune globulin
    3. Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g. a history of necrotizing enterocolitis)
    4. Documented renal nsufficiency, as noted by a creatinine clearance less than 10 mL/min/1.73m2 at time of study enrollment
    5. Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, or maribivir
    6. Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry)
    7. Current receipt of other investigational drugs
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in best ear hearing assessments between baseline and 6 months, and will be assessed for the analysis population only (those subjects randomized to 6 weeks or 6 months of oral valganciclovir).
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline, 6 months, 12 months and 24 months
    E.5.2Secondary end point(s)
    1. Adverse events which lead to permanent discontinuation of valganciclovir therapy or to irreversible outcome of the adverse event.
    2. Change in best ear hearing assessments between baseline and 12 months.
    3. Change in best ear hearing assessments between baseline and 24 months.
    4. Maximum change in hearing assessments between baseline and 6, 12, and 24 months over left and right ears.
    5. Hearing deterioration between baseline and 6, 12, or 24 months over left and right ears.
    6. Neurologic impairment at 12 months of life, utilizing the Bayley Scales of Infant and Toddler Development.
    7. Neurologic impairment at 24 months of life, utilizing the Bayley Scales of Infant and Toddler Development.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the six month treatment period and the one month thereafter, study subjects will be followed weekly for four weeks, then every other week for eight weeks, then every month for four months.Neurodevelopmental assessments at 12 months and 24 months.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned10
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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 the trial is defined as the last clinic visit/contact at year 2 (Protocol section 7.4 ) for the last subject.
    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 months0
    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 months0
    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 Yes
    F.1.1Number of subjects for this age range: 104
    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) Yes
    F.1.1.2.1Number of subjects for this age range: 26
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 26
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 26
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 26
    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) 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
    Enrollment is of babies less than 30 days of age.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 104
    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)
    The care the subject will receive after the trial has ended will be no different to routine clinical care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-20
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