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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2019-001032-54
    Sponsor's Protocol Code Number:19PH192
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-19
    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 number2019-001032-54
    A.3Full title of the trial
    Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy
    Impact du traitement anti-cytomégalovirus (valganciclovir) dans la prise en charge des poussées de rectocolite hémorragique (RCH) nécessitant un traitement par vedolizumab : étude thérapeutique randomisée comparant une stratégie avec ou sans antiviral
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy
    Impact du traitement anti-cytomégalovirus (valganciclovir) dans la prise en charge des poussées de rectocolite hémorragique (RCH) nécessitant un traitement par vedolizumab : étude thérapeutique randomisée comparant une stratégie avec ou sans antiviral
    A.3.2Name or abbreviated title of the trial where available
    CYTOVEDO
    CYTOVEDO
    A.4.1Sponsor's protocol code number19PH192
    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 Saint Etienne
    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 Saint Etienne
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Saint Etienne
    B.5.2Functional name of contact pointproject manager
    B.5.3 Address:
    B.5.3.1Street AddressURCIP - Bâtiment recherche
    B.5.3.2Town/ citySAINT ETIENNE CEDEX 2
    B.5.3.3Post code42055
    B.5.3.4CountryFrance
    B.5.4Telephone number0477829272
    B.5.5Fax number0477127820
    B.5.6E-mailmarie.peuriere@chu-st-etienne.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 valganciclovir
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare France SAS
    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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 vedolizumab
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    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 namevedolizumab
    D.3.4Pharmaceutical form Powder for suspension 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 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
    Patient with active ulcerative colitis who failed to anti-TNF with endoscopic active disease with an endoscopic Mayo score> 1 and 2 biopsies of the inflammatory tissue and presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR.
    Patient avec poussée inflammatoire de rectocolite hémorragique sous anti-TNF avec score Mayo endoscopique > 2 avec infection à CMV dans le tissu inflammatoire (charge virale supérieure à 5 UI/100000cellules)
    E.1.1.1Medical condition in easily understood language
    Patient with active ulcerative colitis who failed to anti-TNF with endoscopic active disease with an endoscopic Mayo score> 2 and presence of a CMV infection (inflammatory tissue = 5UI/100000cells)
    Patient avec poussée inflammatoire de rectocolite hémorragique sous anti-TNF avec score Mayo endo > 2 avec infection à CMV dans le tissu inflammatoire (charge virale supérieure à 5 UI/100000cell)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10058881
    E.1.2Term Cytomegalovirus viremia
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of a therapeutic strategy of co-administration of vedolizumab and antiviral in terms of clinical responses to week 6 in relapsing patients with active UC, anti-TNF failure and CMV positive.
    Evaluer l’efficacité d’une stratégie thérapeutique de co-administration de vedolizumab et d’antiviral en termes de réponses cliniques à S6, chez des patients en poussée porteurs d’une RCH active, en échec aux anti-TNF et positive pour CMV.
    E.2.2Secondary objectives of the trial
    - Compare the two treatment groups (co-prescribing antiviral vs. no antiviral), in relapsing patients with active UC, anti-TNF failure and CMV positive :

    - clinical remission rates at week 6,
    - mucosal healing rates at week 6,
    - CMV viral load (qPCR in inflammatory tissue) at week 6
    - clinical remission rates at week 52
    - the colectomy rate at week 52

    - Evaluate tolerance to antiviral therapy in co-administration with vedolizumab in relapsing patients with active UC, anti-TNF failure and CMV positive.
    - Comparer entre les deux groupes de traitement (co-prescription d’antiviral vs pas d’antiviral), chez des patients en poussée porteurs d’une RCH active, en échec aux anti-TNF et positive pour CMV :

    • les taux de rémission clinique à S6,
    • les taux de cicatrisation muqueuse à S6,
    • la charge virale CMV (qPCR dans le tissu inflammatoire) à S6
    • les taux de rémission clinique à S52
    • le taux de colectomie à S52

    - Evaluer la tolérance au traitement antiviral en co-administration avec le vedolizumab, chez des patients en poussée porteurs d’une RCH active, en échec aux anti-TNF et positive pour CMV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient with active UC
    - Patient with active ulcerative colitis who failed to anti-TNF (infliximab, adalimumab, golimumab) after induction (no primary response) or clinical recurrence (secondary failure).
    - Patient with endoscopic active disease with an endoscopic Mayo score> 2 and 2 biopsies of the inflammatory tissue.
    - Presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR.
    - Patient présentant une RCH active
    - Patient présentant une poussée inflammatoire de RCH sous anti-TNF (infliximab, adalimumab, golimumab) soit après l’induction (non réponse primaire) soit en récidive clinique (échec secondaire).
    - Patient ayant bénéficié d’une rectosigmoïdoscopie montrant un score Mayo endoscopique > 2 avec 2 biopsies du tissu inflammatoire.
    - Présence d’une infection à CMV dans le tissu inflammatoire objectivée par une charge virale supérieure à 5 UI/100000cellules par qPCR.
    E.4Principal exclusion criteria
    - Patient with severe acute colitis
    - Patient treated by ciclosporin or Prograf.
    - HIV+
    - Clostridium difficile infection.
    - CMV positive viremia (strongly recommending the use of an anti-CMV in the recommendations of GETAID). Insofar as the patients included will be in thrust with CMV colic, it is licit to make a blood viremia
    - Patient with intolerance or contraindication to the treatment used
    - Pregnant or breastfeeding woman
    - Patient présentant une colite grave
    - Patient sous ciclosporine ou Prograf.
    - Patient HIV+.
    - Infection à Clostridium difficile.
    - Virémie CMV positive (rendant très fortement conseillée l’utilisation d’un anti-CMV dans les recommandations du GETAID). Dans la mesure où les patients inclus seront en poussée avec du CMV colique, il est licite de faire une virémie sanguine pour éliminer une primo-infection (risque d’infection sévère) ou une multiplication très active du virus lors de la réactivation.
    - Patient présentant une intolérance ou une contre-indication au traitement utilisé
    - Femme enceinte ou allaitante
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients in clinical response to week 6 in the arm with antiviral versus the arm without antiviral
    Pourcentage de patients en réponse clinique à S6 dans le bras avec antiviral versus le bras sans antiviral
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 6
    semaine 6
    E.5.2Secondary end point(s)
    - Clinical remission at week 6
    - Clinical remission at week 52
    - Viral load in tissue at week 6
    - Mucosal healing at week 6
    - Adverse effects in both arms
    - Rate of colectomy at week 52
    - rémission clinique à la semaine 6
    - rémission clinique à la semaine 52
    - valeur de charge virale CMV à la semaine 6
    - cicatrisation muqueuse à la semaine 6
    - nombre et gravité des effets secondaires du traitement
    - nombre de colectomie à la semaine 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 6 and week 52
    semaine 6 et semaine 52
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 Yes
    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
    none
    aucun
    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 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.1.3Elderly (>=65 years) Yes
    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
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    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 Decision2019-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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