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    Summary
    EudraCT Number:2007-004692-19
    Sponsor's Protocol Code Number:963
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-004692-19
    A.3Full title of the trial
    Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study investigating efficacy and safety of Cytotect FH, nanometer filtered (BT094)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study investigating efficacy and safety of Cytotect FH, nanometer filtered (BT094)
    A.3.2Name or abbreviated title of the trial where available
    Prevention of congenital CMV infection in infants of mothers with primary CMV infection during preg.
    A.4.1Sponsor's protocol code number963
    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 organisationJ&P MEDICAL RESEARCH Ltd.
    B.5.2Functional name of contact pointProject Manager Oliver Mauric
    B.5.3 Address:
    B.5.3.1Street AddressMooslackengasse 17
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1190
    B.5.3.4CountryAustria
    B.5.4Telephone number+43 1 876 0432 28
    B.5.5Fax number+43 1 876 0432 33
    B.5.6E-mailoliver.mauric@jp-medical-research.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 nameCytotect FH, nanometer filtered
    D.3.2Product code BT094
    D.3.4Pharmaceutical form Solution for infusion
    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.3.8INN - Proposed INNHuman Cytomegalovirus immunoglobulin
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typenot less then
    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 after primary CMV infection during pregnancy
    E.1.1.1Medical condition in easily understood language
    Congenital CMV infection after primary CMV infection during pregnancy
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Prevention 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 paramter.
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Pregnant women, pregnancy after in-vitro fertilisation permitted
    - CMV-specific IgG seronegative pregnant women at screening
    - 18 to 45 years of age
    - Consent to carrying out a histopathological analysis of foetal brain, liver and kidney biopsy specimen in case of pregnancy termination or spontaneous abortion after confirmed seroconversion during pregnancy
    -Written informed consent
    E.4Principal exclusion criteria
    - women with current multiple pregnancy
    - women who are planning a home birth
    - known immunodeficiency (e.g. congenital agammaglobulinaemia or hypo-gamma-globulinaemia, common variable immunodeficiency, severe combined immuno-deficiencies, Wiskott Aldrich syndrome) or immunosuppression (e.g. renal transplanted patients)
    - known hepatitis B or C infections
    - known intolerance to proteins of human origin
    - known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)
    - Known hypersensitivity to homologous immunoglobulins, especially very rare cases of IgA deficiency, when the patient has antibodies against IgA
    - known HIV infection
    - Known pre-existing risk factors for thrombotic events (e.g. history of vascular disease or thrombotic episodes, women with acquired or inherited thrombophilic disorders, severely hypovolemic women or women with diseases which increase blood viscosity)
    - Known renal insufficiency
    - Known hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed
    - Participation in another clinical trial within 90 days before entering the study or during the study and/or previous participation in this study during the same pregnancy
    - Inability or lack of motivation to participate in the study
    - Pregnant women who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study
    - Not willing or able to provide written informed consent to participation in the study after being informed by the investigator about the aim, course and possible risks of the study
    - Not willing to give consent to transmission of personal “pseudonymised” data to the competent authorities
    - Women who are dependant on study site staff, on Biotest AG or its authorised representatives
    E.5 End points
    E.5.1Primary end point(s)
    Number of CMV infected newborns/foetuses at birth from seroconverted mothers as confirmed by CMV-DNA using PCR in urinanalysis within 7 days after birth or (additionally) CMV-DNA using PCR of amniotic fluid.
    E.5.1.1Timepoint(s) of evaluation of this end point
    n.a.
    E.5.2Secondary end point(s)
    Mother: CMV IgG serum level (recombinant blot with avidity / anti-HCMV rec. gB IgG ELISA)
    Foetus: ultrasound abnormalities (EFSUMB level II/III)
    Newborn: CMV-related clinical symptoms (feature/number/severity of abnormalities and clinically relevant laboratory findings
    E.5.2.1Timepoint(s) of evaluation of this end point
    n.a.
    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
    standard of care (no treatment)
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA150
    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 Information not present in EudraCT
    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.
    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: 98
    F.1.1.1In Utero Yes
    F.1.1.1.1Number of subjects for this age range: 98
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 98
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 98
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 98
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 state3700
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16000
    F.4.2.2In the whole clinical trial 16000
    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 responsibility of the pregnant woman’s own physician.
    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 Decision2008-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-22
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