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    Summary
    EudraCT Number:2020-005582-13
    Sponsor's Protocol Code Number:CHUBX2020/26
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-03
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-005582-13
    A.3Full title of the trial
    Prospective pilot study evaluating a therapeutic synergy between the infusion of CMV-specific immunoglobulins and the level before transplantation of negative gamma delta Vdelta 2 T lymphocytes expressing CD16 in patients seropositive for CMV as preventive treatment for CMV infection by
    Etude pilote prospective évaluant une synergie thérapeutique entre la perfusion d'immunoglobulines spécifiques du CMV et le taux avant la greffe des lymphocytes T gamma delta V delta 2 négatifs exprimant le CD16 chez les patients séropositifs pour le CMV en traitement préventif d'une infection à CMV en transplantation rénale.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Synergy between T lymphocytes and anti-CMV immunoglobulins in the prevention of CMV infection.
    Synergie entre lymphocytes T et immunoglobulines anti-CMV dans la prévention de l’infection à CMV.
    A.3.2Name or abbreviated title of the trial where available
    SYNTAGME
    SYNTAGME
    A.4.1Sponsor's protocol code numberCHUBX2020/26
    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 SponsorCHU de Bordeaux
    B.1.3.4CountryFrance
    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 supportBiotest PHARMA SA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointKAMINSKI
    B.5.3 Address:
    B.5.3.1Street AddressPLACE AMELIE RABA-LEON
    B.5.3.2Town/ cityBORDEAUX
    B.5.3.3Post code33000
    B.5.3.4CountryFrance
    B.5.6E-mailhannah.kaminski@chu-bordeaux.fr
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCYTOTECT CP BIOTEST 100 U/mL
    D.3.4Pharmaceutical form Solution for injection
    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
    CMV infection in transplantation
    Infection à CMV en transplantation
    E.1.1.1Medical condition in easily understood language
    CMV infection in transplantation
    Infection à CMV en transplantation
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate the association between the level of gamma-delta Vdelta2 negative T lymphocytes (LTgdVd2neg) expressing CD16 in peripheral blood on the day of transplantation and the occurrence of an infection with CMV within one year of transplantation in patients with positive CMV (R +) serology prior to kidney transplantation and receiving CMV prophylaxis by infusion of CMV-specific immunoglobulins.
    L’objectif principal est d’évaluer l'association entre le taux de lymphocytes T gamma-delta Vdelta2 négatifs (LTgdVd2neg) exprimant le CD16 dans le sang périphérique le jour de la transplantation et la survenue d’une infection à CMV au cours de l’année suivant la transplantation chez les patients ayant une sérologie CMV positive (R+) avant transplantation rénale et recevant une prophylaxie anti-CMV par perfusions d'immunoglobulines spécifiques du CMV.
    E.2.2Secondary objectives of the trial
    - To assess the association between the level of gamma-delta Vdelta2 negative T lymphocytes expressing CD16 in peripheral blood on the day of transplantation and the occurrence of CMV disease during the year following transplantation in patients with positive CMV serology before renal transplantation and receiving anti-CMV prophylaxis by infusion of CMV-specific immunoglobulins.
    - To determine a threshold of LTgdVd2neg CD16 + predictive of an effective therapeutic response to anti-CMV Ig in R + patients in preventive treatment of post-transplant CMV infection
    - Determine the percentage of NK lymphocytes in peripheral blood expressing CD16, which may be associated with protection from CMV infection after infusion of anti-CMV Ig
    - Describe the phenotypic kinetics of LTgd and NK lymphocytes in patients receiving anti-CMV Ig.
    - Evaluer l'association entre le taux de lymphocytes T gamma-delta Vdelta2 négatifs exprimant le CD16 dans le sang périphérique le jour de la transplantation et la survenue d’une maladie à CMV au cours de l’année suivant la transplantation chez les patients ayant une sérologie CMV positive avant transplantation rénale et recevant une prophylaxie anti-CMV par perfusion d'immunoglobulines spécifiques du CMV.
    - Déterminer un seuil de LTgdVd2neg CD16+ prédictif d'une réponse thérapeutique efficace aux Ig anti-CMV chez les patients R+ en traitement préventif d'une infection à CMV post-transplantation
    - Déterminer le pourcentage des lymphocytes NK dans le sang périphérique exprimant le CD16, pouvant être associés à une protection de l'infection à CMV après perfusion d'Ig anti-CMV
    - Décrire la cinétique phénotypique des LTgd et des lymphocytes NK des patients recevant des Ig-anti CMV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Man or woman over 18 years old,
    2) Patient candidate for a first transplant or re-transplantation, registered on the national waiting list of the Biomedicine Agency.
    3) Patients seropositive for CMV (positive serology during the pre-transplant assessment or on D0 transplant)
    4) Patients receiving a kidney transplant from a deceased donor or a living donor.
    5) Women of childbearing age presenting a negative pregnancy test on inclusion and giving their consent to the establishment of effective contraception throughout the study period and two months after stopping the period of monitoring.
    6) Patient affiliated or beneficiary of a social security insurance.
    1) Homme ou femme âgé(e) de plus de 18 ans,
    2) Patient candidat à une première transplantation ou à une re-transplantation, inscrit sur la liste d’attente nationale de l’Agence de la Biomédecine.
    3) Patients séropositifs pour le CMV (sérologie positive lors du bilan pré-greffe ou à J0 de greffe)
    4) Patients recevant un greffon rénal provenant d’un donneur décédé ou d’un donneur vivant.
    5) Femmes en âge de procréer présentant un test de grossesse négatif à l’inclusion et donnant leur accord pour la mise en place d’une contraception efficace durant toute la période de l’étude et deux mois après l’arrêt de la période de suivi.
    6) Patient affilié ou bénéficiaire d’un régime de sécurité sociale.
    E.4Principal exclusion criteria
    1) Patients seronegative for CMV (R-).
    2) Historical or current Incompatible Graft rate (TGI)> 85%.
    3) Patients who received anti-CMV treatment within 28 days of transplantation.
    4) Indication for induction therapy with anti-lymphocyte globulin, rituximab, polyvalent intravenous immunoglobulins or any other immunomodulatory molecule, and treatment with inhibitor mTOR, themselves described associated with a decrease in the incidence of CMV infections
    5) Patients who have received or are receiving a solid organ transplant other than a kidney transplant.
    6) Patients known to be seropositive for human immunodeficiency virus (HIV), hepatitis B virus (HBV; Ag HbS positive) or hepatitis C virus (HCV; anti-HCV antibodies positive),
    7) Allergy, contraindication or known intolerance to specific anti-CMV Ig, mycophenolic acid, basiliximab, corticosteroids, cyclosporine A, tacrolimus or to excipients of these products.
    8) Any form of substance abuse, psychiatric disorder or any condition, which, according to the investigator, may complicate communication during follow-up.
    9) Foreseeable inability to comply with the visits / check-ups planned in the protocol.
    10) Patients under guardianship / curatorship
    1) Patients séronégatifs pour le CMV (R-).
    2) Taux de Greffon Incompatible (TGI) historique ou actuel > 85%.
    3) Patients ayant reçu un traitement anti-CMV dans les 28 jours avant la transplantation.
    4) Indication à un traitement d’induction par globulines anti-lymphocytaire, rituximab, immunoglobulines polyvalentes intraveineuses ou tout autre molécule immunomodulatrice, et traitement par mTOR inhibiteur, eux-mêmes décrits associés à une diminution de l’incidence des infections à CMV
    5) Patients ayant reçu ou recevant une transplantation d’organe solide autre qu’une transplantation rénale.
    6) Patients connus séropositifs pour le virus de l’immunodéficience humaine (VIH), le virus de l’hépatite B (VHB ; Ag HbS positif) ou le virus de l’hépatite C (VHC ; anticorps anti-VHC positifs),
    7) Allergie, contre-indication ou intolérance connue aux Ig anti-CMV spécifiques, l’acide mycophénolique, le basiliximab, les corticostéroïdes, la cyclosporine A, le tacrolimus ou à des excipients de ces produits.
    8) Toute forme d’abus de substance, de désordre psychiatrique ou tout état, susceptible selon l’investigateur, de compliquer la communication lors du suivi.
    9) Incapacité prévisible à se plier aux visites/bilans planifiés dans le protocole.
    10) Patients sous tutelle/curatelle
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the association between the LTgd CD16 + level on the day of transplantation and the occurrence of CMV infection in the year following transplantation.
    Le critère de jugement principal est l’association entre le taux de LTgd CD16+ le jour de la transplantation et la survenue d’une infection à CMV au cours de l’année suivant la transplantation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after inclusion
    12 mois après l'inclusion
    E.5.2Secondary end point(s)
    1) the association between the level of LTgdVd2neg CD16 + in the peripheral blood on the day of transplantation and the occurrence of CMV disease in the year after transplantation.
    2) the value of LTgdVd2neg CD16 + in peripheral blood on the day of transplantation associated with the absence of CMV infection during the year after transplantation.
    3) the association between the level of NK lymphocytes, another cell population expressing CD16, and the occurrence of CMV infection in the year following transplantation.
    4) the kinetics of the phenotype of LTgdVd2neg CD16 + and NK in peripheral blood at one year of post-transplantation follow-up.
    5) comparison of the incidence of CMV infection in the group of patients in this study compared to that in a historical group of R + patients in preemptive follow-up without CMV Ig.
    1) l’association entre le taux de LTgdVd2neg CD16+ dans le sang périphérique le jour de la transplantation et la survenue d’une maladie à CMV au cours de l’année suivant la transplantation.
    2) la valeur de LTgdVd2neg CD16+ dans le sang périphérique le jour de la transplantation associé à l'absence d'infection à CMV au cours de l’année suivant la transplantation.
    3) l’association entre le taux de lymphocytes NK, autre population cellulaire exprimant le CD16, et la survenue d’une infection à CMV dans l’année suivant la transplantation.
    4) la cinétique du phénotype des LTgdVd2neg CD16+ et des NK dans le sang périphérique à un an de suivi post transplantation.
    5) la comparaison de l’incidence d’une infection à CMV dans le groupe de patients de cette étude comparée à celle dans un groupe historique de patients R+ en suivi préemptif sans Ig CMV.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be assessed 12 months after inclusion
    Tous les critères secondaires seront évalués 12 mois après l'inclusion
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 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
    last visit of the last subject
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 Yes
    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 state36
    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
    aucun
    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 Decision2021-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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