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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2020-000492-21
    Sponsor's Protocol Code Number:7678
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-04-21
    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 number2020-000492-21
    A.3Full title of the trial
    Multicenter randomized two arms study evaluating the efficacy of prophylactic Rituximab in adult EBV negative kidney transplant recipients on incidence of EBV primary infection and post-transplant lymphoproliferative disorders
    Étude prospective multicentrique randomisée évaluant l’efficacité d’un traitement préventif par Rituximab chez des adultes patients transplantés rénaux EBV négatifs sur l’incidence de la primoinfection EBV et des syndromes lymphoprolifératifs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter randomized two arms study evaluating the efficacy of prophylactic Rituximab in adult EBV negative kidney transplant recipients on incidence of EBV primary infection and post-transplant lymphoproliferative disorders
    Étude prospective multicentrique randomisée évaluant l’efficacité d’un traitement préventif par Rituximab chez des adultes patients transplantés rénaux EBV négatifs sur l’incidence de la primoinfection EBV et des syndromes lymphoprolifératifs
    A.3.2Name or abbreviated title of the trial where available
    REPLY
    REPLY
    A.4.1Sponsor's protocol code number7678
    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 SponsorLes Hôpitaux Universitaires de Strasbourg
    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 supportLes Hôpitaux Universitaires de Strasbourg
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLes Hôpitaux Universitaires de Strasbourg
    B.5.2Functional name of contact pointEric DEMONSANT
    B.5.3 Address:
    B.5.3.1Street Address1, place de l'hôpital
    B.5.3.2Town/ cityStrasbourg
    B.5.3.3Post code67091
    B.5.3.4CountryFrance
    B.5.4Telephone number0033388115266
    B.5.5Fax number0033388115494
    B.5.6E-maildpidrci@chru-strasbourg.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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRituximab
    D.3.4Pharmaceutical form Concentrate for 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 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
    Kidney transplantation
    Epstein Barr virus
    Transplantation rénale et virus Epstein Barr
    E.1.1.1Medical condition in easily understood language
    Kidney transplantation
    Epstein Barr virus
    Transplantation rénale et virus Epstein Barr
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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 of our study is to evaluate the efficacy of early infusion of Rituximab in the prevention of EBV primary infection and post-transplant lymphoproliferative disorder (PTLD) occurrence in adult EBV negative kidney transplant recipients transplanted with an EBV positive donor.
    Evaluer l’efficacité d’une perfusion précoce de Rituximab dans la prévention de la primoinfection EBV et du LPT chez le patient adulte EBV séronégatif transplanté avec un donneur EBV séropostitif.
    E.2.2Secondary objectives of the trial
    -The occurrence of PTLD during the 5 post-transplant years
    -The occurrence of post-transplant EBV primary infection during the 5 post-transplant years
    -The kinetics of post-transplant EBV replication
    -The clinical presentation of EBV primary infection
    -The incidence of post-transplant EBV seroconversion during the 5 post-transplant years
    -The post-transplant immune reconstitution kinetics
    -The kidney allograft function and graft survival during the 5 post-transplant years
    -The recipient survival during the 5 post-transplant years
    -The tolerance of Rituximab
    -The incidence of opportunistic infections and malignancies during the 5 years after transplantation
    -The incidence of BK virus and Cytomegalovirus (CMV) infections post-transplantation
    -L’incidence du LPT
    -L’incidence de la primoinfection EBV
    -La cinétique de la réplication de l’EBV
    -La présentation clinique de la primoinfection EBV
    -L’incidence de la séroconversion EBV post-transplantation
    -La cinétique de la reconstitution immunitaire lymphocytaire
    -La fonction du greffon rénal et la survie du greffon
    -La survie du patient
    -La tolérance du Rituximab
    -L’incidence d’infections opportunistes et de cancers
    -L’incidence d’infection à BK virus et à Cytomegalovirus (CMV)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adult patients (age ≥18 years at transplantation)
    -Kidney and kidney pancreas simultaneous transplantation
    -EBV seronegative patients (IgG anti EBNA, IgG anti VCA and IgM anti VCA negative) (from 6 months before transplantation to the day of transplantation, included)
    -Patient who have given written informed consent
    -Negative pregnancy test and use of contraception during all the study
    -EBV positive donor
    -Patient affiliated to a social security scheme
    -Patients de plus de 18 ans affiliés à un régime de protection sociale
    -Patients transplantés du rein et/ou rein-pancréas
    -Patients EBV séronégatifs (IgG anti-EBNA, IgG anti-VCA et IgM anti-VCA négatifs) au moment de la transplantation
    -Patients ayant donné leur consentement écrit
    -Test de grossesse négatif (β-HCG dosage) et utilisation d’une contraception tout au long de l’étude
    -Donneur EBV positif
    E.4Principal exclusion criteria
    -Patient with known HBV active infection
    -Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients
    -Active severe infection
    -Severe Immune deficiency
    -Severe cardiac insufficiency
    -Pregnant or lactating women
    -Women of child bearing potential unless they are using an acceptable birth control methods
    -Patient under judicial protection or under guardianship
    -Patient currently participating in another clinical trial investigating drugs. Observational studies are not considered as an exclusion criterion
    -Any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, is incompatible with the participation in the study
    -Unlikely to comply with the visits scheduled in the protocol
    -Sujet avec infection VHB active connue
    -Hypersensibilité à la substance active ou aux protéines murines, ou à l'un des autres excipients
    -Infection sévère active
    -Immunodéficience sévère
    -Insuffisance cardiaque sévère
    -Femme enceinte ou allaitante
    -Femme en âge de procréer sans contraception efficace
    -Sujet sous sauvegarde de justice
    -Sujet sous tutelle ou curatelle
    -Sujet inclus dans une autre étude de recherche clinique. Les études observationnelles ne sont pas considérées comme critère d’exclusion
    -Toute forme de toxicomanie, de trouble ou d'affection psychiatrique qui, de l'avis de l'investigateur, est incompatible avec la participation à l'étude
    -Patients risquant de ne pas se conformer aux visites prévues dans le protocole
    E.5 End points
    E.5.1Primary end point(s)
    1 year incidence of a composite criteria: EBV primary infection assessed by a positive blood EBV viral load and/or EBV seroconversion ; and/or occurrence of a post-transplant lymphoproliferative disorder
    L’incidence à 1 an d’un critère composite : primoinfection EBV évaluée par PCR sanguine et/ou séroconverison et/ou la survenue d’un syndrome lymphoprolifératif
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year after transplantation
    1 an après la transplantation
    E.5.2Secondary end point(s)
    -1, 2, 3, 4 and 5 years incidence of PTLD after kidney transplantation
    -Incidence of primary EBV infection evaluated by EBV viremia (PCR blood test) at M1, M2, M3, M6, M12, M24, M36, M48, M60 and EBV seroconversion at M1, M3, M6, M12, M24, M36, M48, M60.
    -Delay of occurrence of primary EBV infection
    -Symptoms of EBV primary infection
    -CD19/CD20 reconstitution at M3, M6, M12, M24
    -Graft loss at M1, M2, M3, M6, M12, M24, M36, M48, M60
    -Allograft kidney function evaluated by CKD-EPI formula at M1, M2, M3, M6, M12, M24, M36, M48, M60
    -Recipient survival at M1, M2, M3, M6, M12, M24, M36, M48, M60
    -Incidence of opportunistic infections and malignancies at M1, M2, M3, M6, M12, M24, M36, M48, M60
    -Incidence of BKV viremia (PCR blood test) M1, M3, M6, M12 and M24
    -Delay of BKV viremia
    -Incidence of CMV viremia (PCR blood test) at M1, M3, M6, M12 and M24
    -Delay of CMV viremia
    -Treatment tolerance: allergic reaction, neutropenia
    -AE/SAE
    -Incidence du syndrome lymphoprolifératif à 1, 2, 3, 4 et 5 ans post-transplantation
    -Incidence de primoinfection EBV évaluée par la virémie EBV (PCR sanguine) à 1 , 2, 3, 6, 12, 24, 36, 48 et 60 mois post-transplantation et la séroconversion EBV à 1, 3, 6, 12, 24, 36, 48 et 60 mois post-transplantation
    -Symptomatologie de le primoinfection EBV et son délai de survenue
    -Reconstitution lymphocytaire CD19/CD20 à 3, 6, 12 et 24 mois post-transplantation
    -Survie du patient et du greffon
    -Evaluation de la fonction du greffon rénal par la formule CKD-EPI à 1, 2, 3, 6, 12, 24, 36, 48 et 60 mois post-transplantation
    -Incidence d’infections opportunistes et de malignité à 1, 2, 3, 6, 12, 24, 36, 48 et 60 mois post-transplantation
    -Incidence de l’infection à BK virus évaluée par PCR sanguine à 1, 3, 6, 12 et 24 mois post-transplantation
    -Incidence de l’infection à CMV évaluée par PCR sanguine à 1, 3, 6, 12 et 24 mois post-transplantation
    -Tolérance du traitement par Rituximab, recueil des effets secondaires et des effets secondaires graves
    E.5.2.1Timepoint(s) of evaluation of this end point
    at several diffents timepoint
    à beaucoup de moment différents ( cf secondary endpoint)
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    pas de traitement specifique
    no specific treatment
    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
    pas de traitement spécifique
    no specific treatment
    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 concerned20
    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 undergoing the trial
    Dernière visite du dernier sujet inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state120
    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 Decision2021-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-11
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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