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    Summary
    EudraCT Number:2017-002912-15
    Sponsor's Protocol Code Number:CHUBX2016/40
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-28
    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 number2017-002912-15
    A.3Full title of the trial
    Secondary Prophylaxis after CMV disease in Kidney transplant patients targeted by γδ T cells immunomonitoring.
    Prophylaxie secondaire après une infection à CMV chez les greffés rénaux ciblée par l’immunosurveillance des lymphocytes T γδ.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Secondary prophylaxis after CMV disease in kidney transplants targeted by γδ T cells monitoring.
    Prophylaxie secondaire ciblée par l’immunosurveillance des lymphocytes T γδ après infection à CMV.
    A.3.2Name or abbreviated title of the trial where available
    SPARCKLING
    SPARCKLING
    A.4.1Sponsor's protocol code numberCHUBX2016/40
    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 supportCHU de Bordeaux
    B.4.2CountryFrance
    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 pointHannah Kaminski
    B.5.3 Address:
    B.5.3.1Street AddressPlace Amélie Raba Léon
    B.5.3.2Town/ cityBordeaux
    B.5.3.3Post code33000
    B.5.3.4CountryFrance
    B.5.4Telephone number+33556795449
    B.5.5Fax number+33556796173
    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 Yes
    D.2.1.1.1Trade name Rovalcyte
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namevalganciclovir
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVALGANCICLOVIR HYDROCHLORIDE
    D.3.9.1CAS number 175865-59-5
    D.3.9.4EV Substance CodeSUB16471MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number496.3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 2
    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 Cymevan
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form 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.3.8INN - Proposed INNGANCICLOVIR SODIUM
    D.3.9.1CAS number 107910-75-8
    D.3.9.4EV Substance CodeSUB02312MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 transplants patients
    Patients greffés rénaux
    E.1.1.1Medical condition in easily understood language
    Kidney transplants patients
    Patients greffés rénaux
    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
    We aim to demonstrate that the expansion of γδ T cells at the end of curative treatment predicts the absence of virological and clinical relapses.
    L’objectif principal est d’évaluer l’incidence de la survenue de récidive virologique à un an d’une infection à CMV chez les patients transplantés rénaux bénéficiant d’une prophylaxie basée sur la surveillance des LT γδ.
    E.2.2Secondary objectives of the trial
    - Assessment of the incidence of clinical recurrence at one year of CMV infection in renal transplant patients with the choice of prophylaxis based on LT γδ monitoring.
    - description of the dynamics of LT γδ expansion in all patients.
    - Assessment of the incidence of clinical or virological recurrence upon discontinuation of prophylaxis.
    - Evaluation of the duration of secondary prophylaxis with this strategy.
    - The evaluation of the saving of prophylaxis treatment.
    - Assessing the impact of antiviral resistant infections confirmed by genotypic analysis (UL97 and UL54 mutations) sought in recidivism in case of clinical suspicion.
    - Evaluation of patients with adverse reaction (AR) and / or severe AR (SIG).
    - Evaluation of renal function by GFR in MDRD at one year of infection.
    - Assessment of adherence.
    - L’évaluation de l’incidence de la récidive clinique à un an d’une infection à CMV chez les patients transplantés rénaux avec le choix d’une prophylaxie basée sur la surveillance des LT γδ.
    - La description de la dynamique de l’expansion de LT γδ chez tous les patients.
    - L’évaluation de l’incidence de récidive clinique ou virologique à l’arrêt du traitement prophylaxique.
    - L’évaluation de la durée de la prophylaxie secondaire avec cette stratégie.
    - L’évaluation de l’épargne de traitement prophylaxique.
    - L’évaluation de l’incidence des infections résistantes aux antiviraux confirmées par analyse génotypique (mutations UL97 et UL54) recherchées lors de la récidive en cas de suspicion clinique.
    - L’évaluation des patients présentant un effet indésirable (EI) et/ou un EI grave (EIG).
    - L’évaluation de la fonction rénale par le DFG en MDRD à un an de l’infection.
    - L’évaluation de l’observance.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female over 18 years of age without weight or ethnicity, kidney transplant.
    - Affiliate or beneficiary of a social security scheme.
    - Patient with CMV infection symptomatic or not and requiring curative treatment with ganciclovir or valganciclovir.
    - Free, informed and written consent signed by the participant and the investigator (at the latest, the day of inclusion and before any examination required by the research).
    - Homme ou femme âgé de plus de 18 ans sans critère de poids ni d’ethnie, greffé de rein.
    - Patient affilié ou bénéficiaire d’un régime de sécurité sociale.
    - Patient présentant une infection à CMV symptomatique ou non et nécessitant un traitement curatif par ganciclovir ou valganciclovir.
    - Consentement libre, éclairé et écrit signé par le participant et l’investigateur (au plus tard, le jour de l’inclusion et avant tout examen nécessité par la recherche).
    E.4Principal exclusion criteria
    - Documented resistance to antivirals.
    - Patient hemodialysis.
    - Neutrophil count less than 500 / μL and / or platelet count less than 25,000 / μL, and / or lower hemoglobin 8 g / dL.
    - Contraindication to valganciclovir, including known hypersensitivity to valganciclovir and / or aciclovir and / or valaciclovir or to ganciclovir or their excipients, known severe intolerance to valganciclovir or ganciclovir.
    - Women of childbearing age without pregnancy test negative at inclusion and without effective contraception (estrogen-progestogen, intra-uterine device) throughout the study period and two months after the end of the follow-up period.
    - Nursing women.
    - Men without recourse to mechanical contraception during treatment and for at least 90 days after treatment.
    - On-going participation in another clinical trial to evaluate a drug. Participation in an observational study will not be considered a contraindication.
    - Predictable inability of the patient to comply with planned visits in the protocol.
    - Non-negativity of the CMV PCR at 8 weeks (5%, n = 2).
    - Résistance documentée aux antiviraux.
    - Patient hémodialysés.
    - Nombre de polynucléaires neutrophiles inférieur à 500/µL et/ou nombre de plaquettes inférieur à 25 000/µL, et/ou hémoglobine inférieure 8 g/dL.
    - Contre-indication au valganciclovir, dont hypersensibilité connue au valganciclovir et/ou aciclovir et/ou valaciclovir ou au ganciclovir ou à leurs excipients, intolérance sévère connue au valganciclovir ou ganciclovir.
    - Les femmes en âge de procréer sans test de grossesse négatif à l’inclusion et sans contraception efficace (œstroprogestatif, dispositif intra utérin) durant toute la période de l’étude et deux mois après l’arrêt de la période de suivi.
    - Femmes allaitantes.
    - Hommes sans recours à une contraception mécanique durant le traitement et pendant au moins 90 jours après le traitement.
    - Participation en cours à un autre essai clinique d’évaluation d’un médicament. La participation à une étude observationnelle ne sera pas considérée comme une contre-indication.
    - Incapacité prévisible du patient à se plier aux visites planifiées dans le protocole.
    - Non négativation de la PCR CMV à 8 semaines (5%, n=2).
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the cumulative incidence of virologic recurrence at one year of CMV infection. Recurrence is defined as positive CMV (as measured at M1, M2, M3, M6, M9 and M12 after the onset of infection).
    Le critère de jugement principal est l’incidence cumulée de la récidive virologique à un an d’une infection à CMV. La récidive est définie par une ADNémie CMV positive (mesurée à M1, M2, M3, M6, M9 et M12 après le début de l’infection).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    Criteria for effectiveness:
    - The percentage and its standard deviation of one-year clinical recurrences of CMV infection in renal transplant patients with prophylaxis based on LTγδ monitoring.
    - The description of the kinetics of LT γδ.
    - The proportion of infections resistant to antivirals confirmed by genotypic analysis (mutations UL97 and UL54) sought during the recurrence in case of clinical suspicion.
    - The percentage and standard deviation of clinical or virological recurrences at the end of prophylaxis.
    - The mean duration and its standard deviation of secondary prophylaxis with this strategy.
    - The evaluation of the saving of prophylaxis treatment by number of subject and duration of treatment.
    - mean GFR and estimated standard deviation (according to the MDRD formula) to M12.
    - Observance with a patient notebook.
    Tolerance criteria:
    - Proportion of patients with an adverse reaction (AR) and / or a severe AR (SAE).
    Les critères de jugement secondaires sont des :
    Critères d’efficacité :
    - Le pourcentage et son écart-type des récidives cliniques à un an d’une infection à CMV chez les patients transplantés rénaux avec une prophylaxie basée sur la surveillance des LTγδ.
    - La description de la cinétique des LT γδ.
    - La proportion des infections résistantes aux antiviraux confirmées par analyse génotypique (mutations UL97 et UL54) recherchées lors de la récidive en cas de suspicion clinique.
    - Le pourcentage et écart-type des récidives cliniques ou virologiques à l’arrêt du traitement prophylaxique.
    - La durée moyenne et son écart-type de la prophylaxie secondaire avec cette stratégie.
    - L’évaluation de l’épargne de traitement prophylaxique par nombre de sujet et durée de traitement.
    - DFG moyen et écart-type estimé (selon la formule MDRD) à M12.
    - L’observance avec un cahier patient.
    Critères de tolérance :
    - Proportion de patients présentant un effet indésirable (EI) et/ou un EI grave (EIG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    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 Yes
    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) 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 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 concerned2
    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 patient last visit
    Derniere visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state37
    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
    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 Decision2017-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-23
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