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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   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:2013-003068-30
    Sponsor's Protocol Code Number:CMV-MM-2
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003068-30
    A.3Full title of the trial
    CONgenital Cytomegalovirus: Efficacy of antiviral treatment in a non-Randomized Trial with historical control group
    CONgenitaal Cytomegalovirus: Effectiviteit van antivirale behandeling in een niet-geRandomiseerde studie met historische controle groep
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of antiviral treatment of congenital cytomegalovirus in a non-randomized trial with historical control group
    Effectiviteit van antivirale behandeling van congenitale cytomegalovirus in een niet-gerandomiseerde studie met historische controle groep
    A.3.2Name or abbreviated title of the trial where available
    CONCERT study 2.0
    CONCERT studie 2.0
    A.4.1Sponsor's protocol code numberCMV-MM-2
    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 SponsorLUMC
    B.1.3.4CountryNetherlands
    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 supportFonds NutsOhra
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLUMC
    B.5.2Functional name of contact pointFleurtje Schornagel
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310715265383
    B.5.5Fax number00310715266761
    B.5.6E-mailf.a.j.schornagel@lumc.nl
    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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.2Product code 34730
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNVALGANCICLOVIR HYDROCHLORIDE
    D.3.9.1CAS number 175865-59-5
    D.3.9.4EV Substance CodeSUB16471MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Congenital cytomegalovirus infection.
    Sensorineural Hearingloss.
    Congenitale cytomegalovirus infectie.
    Sensorineurale Gehoorverlies.
    E.1.1.1Medical condition in easily understood language
    Congenital cytomegalovirus infection.
    Hearingloss.
    Aangeboren (via de baarmoeder) cytomegalovirus infectie.
    Gehoorverlies.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10010420
    E.1.2Term Congenital CMV infection
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigate whether early valganciclovir treatment of children with SNHL of ≥ 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent deterioration of the hearing loss at 18-22 months follow­-up.
    Onderzoeken of vroege behandeling met valganciclovir bij kinderen met gehoorverlies van ≥ 20 dB, unilateraal of bilateraal, en een congenitale CMV infectie de verergering van het gehoorverlies bij 18-22 maanden follow-up kan tegegaan.
    E.2.2Secondary objectives of the trial
    1) Investigate whether early valganciclovir treatment of children with
    SNHL of ≥ 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent cognitive and motor retardation. Communicative and speech development will be extensively assessed.
    2) Investigate whether early valganciclovir treatment of children with
    SNHL of ≥ 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection reduces the CMV viral load in urine and blood samples during 6 weeks treatment and one week after completion of treatment. At age 18-22 months (follow-up) solely the urine sample will be investigated for the viral load.
    3) Investigate whether drug resistance has evolved.
    1) Onderzoeken of vroege behandeling met valganciclovir bij kinderen met gehoorverlies van ≥ 20 dB, unilateraal of bilateraal, en een congenitale CMV infectie cognitieve en bewegings retardatie kan
    voorkomen. Communicatieve en spraak ontwikkeling worden getest bij 18-22 maanden leeftijd follow-up.
    2) Onderzoeken of vroege behandeling met valganciclovir bij kinderen met gehoorverlies van ≥ 20 dB, unilateraal of bilateraal, en een congenitale CMV infectie de CMV virale load zal verlagen in urine en
    bloed dat wekelijks wordt afgenomen gedurende de 7 weken na inclusie, en bij 18-22 maanden. Bij 18-22 maanden zal alleen urine worden afgenomen.
    3) Eventuele medicatie resistentie onderzoeken.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Treatment group and refusal control group
    - Infants with congenital CMV infection, and hearing loss (≥ 20 dB, in one or both ears).
    - Age at time of inclusion is ≤ 12 weeks after birth.
    - Born at ≥ 37 weeks gestational age.
    - Birth weight ≥ 2500 gram.
    - Parental signed informed consent.

    Historical control group
    - Infants with congenital CMV infection, and hearing loss (≥ 20 dB, in one or both ears).
    - Age at time of inclusion is > 13 weeks after birth.
    - Born at ≥ 37 weeks gestational age.
    - Birth weight ≥ 2500 gram.
    - Parental signed informed consent.
    Behandel groep en weiger controle groep:
    - Kinderen met congenitaal CMV en gehoorverlies (≥ 20 dB unilateraal of bilateraal)
    - Leeftijd bij inclusie ≤ 12 weken.
    - Geboorte bij ≥ 37 weken na conceptie.
    - Geboorte gewicht ≥ 2500 gram.
    - Toestemmingsverklaring door ouders ondertekend.

    Historische controle groep:
    - Kinderen met congenitaal CMV en gehoorverlies (≥ 20 dB, unilateraal of bilateraal).
    - Leeftijd bij inclusie > 13 weken na geboorte.
    - Geboren bij ≥ 37 na conceptie.
    - Geboorte gewicht ≥ 2500 gram.
    - Toestemmingsverklaring door ouders ondertekend.
    E.4Principal exclusion criteria
    Treatment group and refusal control group
    - Previously noted (≤ 12 weeks after birth) symptoms possibly related to congenital CMV, for which medical attention was requested. For example: intra uterine growth retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly, thrombocytopenia, elevated transaminases, elevated bilirubin.
    - Treatment with other antiviral agents or immunoglobulins.
    - Solely applicable for treatment group: leucopenia < 0,5 x 10*9/L (blood sample tested at t=0).


    Historical control group
    - Previously encountered (≤ 12 weeks after birth) symptoms possibly related to congenital CMV, for which medical attention was requested For example: intra uterine growth retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly, thrombocytopenia, elevated transaminases, elevated bilirubin.
    - Treatment with (val)ganciclovir.
    - Treatment with other antiviral agents or immunoglobulins.
    Behandel groep en weiger controle groep:
    - Eerder gevonden (≤ 12 weken na geboorte) symptomen mogelijk passend bij congenitaal CMV, waarvoor medische zorg werd gezocht. Bijvoorbeeld: intra uteriene groei achterstand, petechieen, hepatosplenomegalie, icterus, microcephalie, thrombocytopenie, verhoogde transaminasen, hyperbilirubine.
    - Behandeling met andere antivirale medicatie of immunoglobulines.
    - Voor behandel groep: leukopenie < 0,5 x 10*9/L (bloed getest bij t=0).

    Historische controle groep:
    - Eerder gevonden (≤ 12 weken na geboorte) symptomen mogelijk passend bij congenitaal CMV, waarvoor medische zorg werd gezocht. Bijvoorbeeld: intra uteriene groei achterstand, petechieen, hepatosplenomegalie, icterus, microcephalie, thrombocytopenie, verhoogde transaminasen, hyperbilirubine.
    - Behandeling met (val)ganciclovir.
    - Behandeling met ander antivirale medicatie of immunoglobulines.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the status of the sensorineural hearing loss expressed in dB, in children with congenital CMV at age 18-22 months follow-up.
    Sensorineural gehoorverlies (in dB), bij kinderen met congenitaal CMV bij leeftijd 18-22 maanden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Hearing loss will be evaluated at age 18-22 months.
    Gehoorverlies wordt bepaald bij leeftijd 18-22 maanden.
    E.5.2Secondary end point(s)
    The secondary endpoint is the development of the infants.

    The tertiary endpoint is the viral load (in dried blood spots,blood and urine) during 7 weeks after inclusion and at age 18-22 months follow-up (for infants in the treatment and refusal control group). For infants in the historical control group materials collected previously will be tested when available.

    The final endpoint is the possibility of development of drug resistance.
    Secundaire eindpunt is de ontwikkeling van de kinderen.

    Tertiaire eindpunt is de virale load (in dried blood spot, bloed en urine) gedurende de 7 weken na inclusie en bij 18-22 maanden follow-up (voor kinderen in de behandel en weiger controle groep). Voor kinderen in de historische controle groep zullen deze materialen ook worden getest indien beschikbaar.

    Als laatste eindpunt wordt eventuele medicatie resistentie onderzocht.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The development of the infants will be tested at age 18-22 months follow-up.
    For treated infants and infants in the refusal control group the viral load will be determined at inclusion and weekly in urine during
    the first 7 weeks after inclusion (total 8 moments). For treated infants it will be determined at inclusion and weekly in blood samples (total 8 moments). For untreated infants it will be determined twice in blood (at inclusion and in week 6). At age 18-22 months follow-up the viral load will be determined in urine for all infants (also the infants in the historical control group).
    De ontwikkeling van de kinderen wordt bij leeftijd 18-22 maanden follow-up onderzocht.

    De behandelde kinderen en kinderen in de weiger controle groep wordt de virale load bij inclusie en daarna wekelijks gedurende de 7 weken na inclusie bepaald (totaal 8 momenten). Voor behandelde kinderen wordt bij inclusie en daar wekelijks gedurende de behandeling de virale load in bloed bepaald (totaal 8 momenten). Voor onbehandelde kinderen wordt de virale load in bloed tweemaal bepaald (inclusie en in week 6). Bij leeftijd 18-22 maanden wordt voor alle kinderen de virale load in urine bepaald (ook voor kinderen in de historische controle groep).
    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 No
    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) 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 No
    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
    Reguliere behandeling
    Regular care
    E.8.2.4Number of treatment arms in the trial3
    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 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 last visit of the last subject.
    Het laatste bezoek van de laatste proefpersoon.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 50
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 50
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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.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)
    None other than expected normal treatment. All subjects in the treatment group will have been treated at the start of the trial. Treatment of congenital CMV after
    1 year of age has not been shown to be effective. Treatment of hearing loss will be continued as standard care in the Netherlands.
    It is possible that follow-up after 18-22 months will be provided. However, this is beyond this specific trial.
    Niet afwijkend van normale behandeling voor gehoorverlies. Aile proefpersonen in de behandel groep zijn behandeld in het begin van de studie. Er bestaat geen bewijs voor effectiviteit voor de behandeling van congenitaal CMV na de leeftijd van 1 jaar. Behandeling van gehoorverlies zal voortduren zoals in reguliere zorg. Het is mogelijk dat follow-up na 18-22 maanden ook zal worden aangeboden. Dit is echter buiten deze studie om.
    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 Decision2013-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-30
    P. End of Trial
    P.End of Trial StatusCompleted
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