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    Summary
    EudraCT Number:2020-002383-32
    Sponsor's Protocol Code Number:997
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-01
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-002383-32
    A.3Full title of the trial
    Prevention of maternal-fetal Cytomegalovirus transmission after primary maternal infection with gestational age ≤ 14 weeks – an open-label, single-arm, prospective trial investigating efficacy and safety of Cytotect CP Biotest
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study investigating efficacy and safety of Cytotect CP Biotest in preventing maternal-fetal transmission of cytomegalovirus
    A.3.2Name or abbreviated title of the trial where available
    PreCyssion
    A.4.1Sponsor's protocol code number997
    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 organisationBiotest AG
    B.5.2Functional name of contact pointCorporate Clinical Research
    B.5.3 Address:
    B.5.3.1Street AddressLandsteinerstraße 5
    B.5.3.2Town/ cityDreieich
    B.5.3.3Post code63303
    B.5.3.4CountryGermany
    B.5.4Telephone number004961038019865
    B.5.5Fax number00496103801180
    B.5.6E-mail997@biotest.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 Yes
    D.2.1.1.1Trade name Cytotect CP Biotest 100 U/mL solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderBiotest Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/06/408
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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) No
    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
    Prevention of maternal-fetal cytomegalovirus transmission after primary maternal infection with gestational age ≤ 14 weeks
    E.1.1.1Medical condition in easily understood language
    Prevention of cytomegalovirus transimission from mother to fetus during early pregnancy
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036654
    E.1.2Term Prevention
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main purpose of the trial is to demonstrate efficacy and safety of Cytotect CP Biotest in preventing maternal-fetal transmission of cytomegalovirus (CMV).
    Primary Objective
    • To determine the overall rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation)
    E.2.2Secondary objectives of the trial
    Efficacy:
    • To determine the rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation) in the 2 subgroups:
    o Subjects with periconceptionally acquired infection
    o Subjects with infection acquired during first trimester
    • To measure maternal CMV viral load, anti-CMV IgG Levels, anti-CMV IgG avidity, anti-CMV IgM index
    • To determine soluble fms-like tyrosine kinase 1 (sFlt-1) concentration in maternal serum
    • To evaluate vitality and growth of the fetuses/newborns
    •To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery
    • To measure the number of CMV-DNA copies in the urine of newborns
    Safety:
    Trial Subject
    • To assess the number, severity, causality, outcome, and seriousness of all adverse events (AEs)/ treatment-emergent AEs (TEAEs)/ AEs of special interest until delivery (+3 days) in both mother and fetus/ newborn
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained from subjects indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it
    2. Pregnant women, age 18 to 45 years
    3. Pregnant women at trial entry with gestational age ≤14 weeks; pregnancy after in-vitro fertilization permitted
    4. Detection of early primary CMV infection
    E.4Principal exclusion criteria
    1. Women with current multiple pregnancy
    2. History of severe pre-eclampsia or severe gestational hypertension (GHTN), which required medical intervention. Definition according to AWMF guideline (AWMF, 2019)
    3. Presence of severe disease impairing course of pregnancy (e.g. diabetes, epilepsy, cancer)
    4. Clinically significant congenital or acquired autoimmune disease
    5. Known immunosuppressive (e.g., transplanted patients) or immunodeficient condition
    6. Known infection with hepatitis B or C, or HIV from the medical history or active infection at screening as assessed by respective virus serology
    7. Maternal CMV infection prior to this pregnancy
    8. Covid-19 infection at time of inclusion
    9. Any signs or symptoms indicating an increased risk of abortion or premature labor or has known negative effect on fetus with exception of a CMV infection
    10. Active infection according to TORCH serology with exception of CMV in the assessment of the investigator
    11. Known major fetal anomalies or demise
    12. Intolerance to proteins of human origin or known allergic reactions to components of the trial product
    13. Selective absolute IgA deficiency or known antibodies to IgA
    14. Known pre-existing clinically relevant risk factors for thrombotic events
    15. Known renal insufficiency with serum creatinine levels >1.4 mg/dL and proteinuria (albuminuria) at screening (≥30 mg/dL or dipstick reading of 1+ and greater)
    16. Participation in another clinical trial within 90 days before entering the trial or during the trial
    17. Women who are dependent on trial site staff, on Biotest AG or its authorized representatives
    18. Inability or lacking motivation to participate in the trial
    19. Medical condition, laboratory finding, or physical examination finding that in the opinion of the investigator precludes participation
    20. Eligibility for a subgroup where enrollment was stopped
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the overall rate of maternal-fetal transmission at the time of amniocentesis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 20 [- 1 week / +2 weeks] of gestation
    E.5.2Secondary end point(s)
    • Maternal-fetal CMV transmission in the subgroups
    • CMV viral load (CMV DNA copies/mL) in maternal blood
    • Anti-CMV IgG levels
    • Anti-CMV IgG avidity
    • Detection of CMV IgG and IgM antibodies
    • Soluble fms-like tyrosine kinase 1 (sFlt-1) / Placental Growth Factor (PlGF)
    • Vitality, growth and heart rate of the fetus and Apgar-score, head circumference at delivery
    • CMV-DNA at delivery or within the first 3 days in urine of the newborn
    E.5.2.1Timepoint(s) of evaluation of this end point
    During pregnancy, at week 20 [- 1 week / +2 weeks] of gestation and at delivery
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Prevention of viral maternal-fetal transmission during pregnancy
    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 No
    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 No
    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 concerned5
    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
    Date of delivery (+3 days) for the last subject in the trial
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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.1.1.1In 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) No
    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: 80
    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 state80
    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
    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 Decision2021-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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