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    Summary
    EudraCT Number:2007-004692-19
    Sponsor's Protocol Code Number:BIOTEST963
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-004692-19
    A.3Full title of the trial
    Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus during pregnancy. A randomised, open, controlled, prospective, multicentre and multinational study investigating efficacy and safety of Cytotect FH, nanometer filtered (BT094).
    Prevenzione dell'infezione congenita da citomegalovirus nei neonati di madri con infezione primaria da citomegalovirus in gravidanza. Studio prospettico multicentrico e multinazionale, randomizzato, in aperto, controllato, per esaminare l'efficacia e la sicurezza di Cytotect FH, nanofiltrato (BT094).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of congenital CMV infection in infants of mothers with primary CMV infection during pregnancy
    Prevenzione dell'infezione congenita da CMV in neonati di madri con infezione primaria da CMV durante la gravidanza
    A.3.2Name or abbreviated title of the trial where available
    Biotest 963
    Biotest 963
    A.4.1Sponsor's protocol code numberBIOTEST963
    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 SponsorBIOTEST AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBIOTEST AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDIMENSIONE RICERCA
    B.5.2Functional name of contact pointREGULATORY APPROVAL MANAGER
    B.5.3 Address:
    B.5.3.1Street AddressVIALE PARIOLI 12
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00197
    B.5.3.4CountryItaly
    B.5.4Telephone number0680693528
    B.5.5Fax number0680693521
    B.5.6E-mailp.vietti@dimensione-ricerca.com
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/052/06
    D.3 Description of the IMP
    D.3.1Product nameBIOTEST 963
    D.3.2Product code BT094
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBT094
    D.3.9.3Other descriptive namehuman immunoglobulin
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number70
    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.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 CMV INFECTION IN NEWBORN FROM MOTHERS WITH PRIMARY CMV INFECTION DURING PREGNANCY
    INFEZIONE CONGENITA DA CMV IN NEONATI NATI DA MADRI CON INFEZIONE PRIMARIA DURANTE LA GRAVIDANZA
    E.1.1.1Medical condition in easily understood language
    CMV INFECTION IN NEWBORN FROM MOTHERS WITH CMV INFECTION DURING THE PREGNANCY
    INFEZIONE DA CMV IN NEONATI NATI DA MADRI CON INFEZIONE DA CMV DURANTE LA GRAVIDANZA
    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 SOC
    E.1.2Classification code 10010331
    E.1.2Term Congenital, familial and genetic disorders
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10010420
    E.1.2Term Congenital CMV infection
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    OREVENTION OF CONGENITAL CMV INFECTION IN INFANTS OF MOTHERS WITH PRIMARY CMV INFECTION DURING PREGNANCY. THE NUMBER (PERCENTAGE)OF NEWBORNS/FOETUSES WITH CONGENITAL CMV INFECTION IS DEFINED AS THE PRIMARY EFFICACY PARAMETER.
    PREVENZIONE DELL'INFEZIONE CONGENITA DA CITOMEGALOVIRUS CONSEGUENTE A INFEZIONE PRIMARIA DA CMV.CONFRONTO DEL NUMERO DI NEONATI/FETI CON INFEZIONE CONGENITA DA CMV DA MADRI TRATTATE CON BT094 (GRUPPO A), RISPETTO ALLE MADRI NON TRATTATE (GRUPPO B)
    E.2.2Secondary objectives of the trial
    AS MOST IMPORTANT SECONDARY EFFICACY ENDPOINTS CMV SPECIFIC IgG SERUM CONCENTRATION IN MATERNAL BLOOD, ULTRASOUND ABNORMALITIES OF THE FOETUS AND CMV RELATED CLINICAL SYMPTOMS IN THE INFANT WILL BE EVALUATED.
    ENDPOINT SECONDARIO SULL'EFFICACIA è LA CONCENTRAZIONE DI IgG NEL SANGUE MATERNO,SARANNO VALUTATE ANOMALIE CON ECOGRAFIA DEL FETO E I SINTOMI CLINICI RELATAVI A CMV NEI NEONATI
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    1. CENTRAL ASSESSMENT OF PLACENTAL TISSUE (page 51 of 70 protocol vers. 3 07/01/2008)Primary objective: Assessment of placental ijury and assessment of compensatory adaptation

    ALTRI SOTTOSTUDI:
    1.VALUTAZIONE CENTRALE DEL TESSUTO PLACENTARE (PAG 51 DI 70 DEL PROTOCOLLO VERS.3 DEL 07/01/2008); Obiettivo Primario:valutazione del danno placentare e dell'adattamento compensatorio

    E.3Principal inclusion criteria
    1. OREGNANT WOMAN, PREGNANCY AFTER IN VITRO FERTILISATION PERMITTED 2. CMV-SPECIFIC IgG seronegative pregnant women at study entry 3. 18 to 45 years of age 4. consent to carrying out a histopatological analysis of foetal brain, liver and pleen biopsy specimen in case of pregnancy termination or spontaneous abortion after confirmed serconversion during pregnancy.
    1. DONNE INCINTE, SONO PERMESSE ANCHE GRAVIDANZE DOVUTE A FECONDAZIONE IN VITRO 2. DONNE INCINTE CON IgG anti CMV seronegative 3. DONNE DAI 18 AI 45 ANNI D'ETA' 4. DONNE INCINTE CHE CONSENTONO L'ANALISI ISTOPATOLOGICA DEL CERVELLO del feto, BIOPSIA DEL FEGATO E DELLA MILZA IN CASO DI DON NE INCINTE CHE HANNO ABORTO SPONTANEO DOPO LA CONFERMA DELLA SIEROCONVERSIONE DURANTE LA GRAVIDANZA.
    E.4Principal exclusion criteria
    1. women with multigravidity 2. women who are planning a home birth 3. known immunodeficiency or immunosuppression 4. known hepatitis Bor C infections 5. known intolerance to proteins of human origin 6.known intolerance to immunoglobulins or comparable substances 7. known or suspected deficiency of immunoglobulin A 8. known HIV infection 9. Known hypersensivity and/or idiosyncrasy to any of the test compounds or excipients amployed.
    1. donne con multi gravidanza 2. donne che hanno programmato un parto a casa 3. nota immunosoppressione o immunodeficienza 4. nota infezione da epatite B o C 5. nota intolleranza alle proteine di origine umana 6. nota intolleranza alle immunoglobuline o alle sostanze comparabili 7. noto o sospetto deficit di immunoglobulina A 8. nota infezione da HIV 9. nota ipersensibilità e/o idiosincrasia a qualsiasi componenete del farmaco test o eccipiente usato.
    E.5 End points
    E.5.1Primary end point(s)
    number of CMV infected newborns/foetuses at birth from seroconverted mothers as confrimed by CMV-DNA using PCR in urinanalysis within 7 days after birth or (additionally) CMV-DNA using PCR of amniotic fluid.
    numero di neonati/feti infetti alla nascitada CMV da madri sieroconvertite come confermato da CMV-DNA PCR nell'analisi delle urine entro 7 giorni dalla nascita o in aggiunta CMV-DNA PCR del liquido amniotico
    E.5.1.1Timepoint(s) of evaluation of this end point
    duration for the individual pregnant woman depens on CMV serology status, timepoint of inclusion and timepoint of possible CMV seroconversion (about 1 day - 9 months)
    dipende dallo stato sierologico CMV, dal momento dell'inclusione e dal momento della possibile sieroconvrsione CMV ( cica 1 giorno-9 mesi)
    E.5.2Secondary end point(s)
    mother: CMV igG serum level (recombinant blot with avidity/ antiHCMV rec. gB igG ELISA); Foetus: ultrasound abnormalities (EFSUMB level II/III); newborn: clinical symptoms parameters( feature/number/severity of abnormalities and clinically relevant laboratory findings)
    livelli sierici di IgG anti CMV nella madre (immunoblot ricombinante con indice di avidità/test ELISA per le IgG anti HCMV gB ricombinante); nel feto anomalie all'ecografia (EFSUMB livello II/III); nel neonato sintomi clinici correlati al CMV (caratteristiche/numero/gravità delle anomalie e risultati di laboratorio clinicamente rilavanti)
    E.5.2.1Timepoint(s) of evaluation of this end point
    from 1 day to 9 months
    da 1 giorno a 9 mesi
    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 No
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    terapia standard
    standard care
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA409
    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
    The end of the trial is defined as the last visit of the last infant of 2 years undergoing the trial.
    La fine dello studio è definita come l'ultimo visita all'ultimo bambino di 2 anni nato da madre arruolata nello studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 100000
    F.1.1.1In Utero Yes
    F.1.1.1.1Number of subjects for this age range: 25000
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 25000
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 25000
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 25000
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25000
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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 state3600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25000
    F.4.2.2In the whole clinical trial 25000
    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)
    Treatment after end of study drug treatment and medical care given to the pregnant woman after the end of the study is the responsability of the pregnant woman's own physician.
    Il trattamento dopo la fine dello studio e la fine della somministrazione del farmaco sperimentale alle donne incinte è responsabilità del proprio medico curante.
    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 Decision2012-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
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    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
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