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    Summary
    EudraCT Number:2013-004445-17
    Sponsor's Protocol Code Number:hCMV2013
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-01-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-004445-17
    A.3Full title of the trial
    A PROSPECTIVE RANDOMIZED STUDY FOR PREDICTING HUMAN CYTOMEGALOVIRUS (hCMV) INFECTION ACCORDING TO BASELINE hCMV-SPECIFIC T-CELL RESPONSE IN KIDNEY TRANSPLANT PATIENTS
    ESTUDIO PROSPECTIVO, ALEATORIZADO PARA LA PREDCCIÓN DE LA INFECCIÓN POR CITOMEGALOVIRUS HUMANO (hCMV) SEGÚN LA RESPUESTA INMUNOLÓGICA CELULAR ESPECÍFICA BASAL CONTRA EL hCMV EN TRASPLANTADOS RENALES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY FOR THE PREDICTION OF CYTOMEGALOVIRUS INFECTION IN RENAL TRANSPLANT PATIENTS BY THE EVALUATION OF THE IMMUNE RESPONSE BEFORE TRANSPLANTATION
    ESTUDIO PARA LA PREDICCIÓN DE LA INFECCION POR CITOMEGALOVIRUS EN PACIENTES TRANSPLANTADOS RENALES MEDIANTE LA EVALUACIÓN DE LA RESPUESTA INMUNE ANTES DEL TRANSPLANTE
    A.3.2Name or abbreviated title of the trial where available
    RESPECT
    RESPECT
    A.4.1Sponsor's protocol code numberhCMV2013
    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 SponsorHOSPITAL UNIVERSITARI DE BELLVITGE
    B.1.3.4CountrySpain
    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 supportIDIBELL- INSTITUT D'INVESTIGACIÓ BIOMÈDICA DE BELLVITGE
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIDIBELL- INSTITUT D'INVESTIGACIÓ BIOMÈDICA DE BELLVITGE
    B.5.2Functional name of contact pointCAROLINA POLO
    B.5.3 Address:
    B.5.3.1Street AddressFEIXA LLARGA, S/N
    B.5.3.2Town/ cityL'HOSPITALET DE LLOBREGAT
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932607385
    B.5.5Fax number0034932607307
    B.5.6E-mailcpolo@idibell.cat
    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 valcyte
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Farma
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Coated 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
    D.3.9.1CAS number 175865-60-8
    D.3.9.4EV Substance CodeSUB00007MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number450
    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 CYMEVENE
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Powder for solution for infusion
    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
    D.3.9.1CAS number 82410-32-0
    D.3.9.4EV Substance CodeSUB07881MIG
    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.IMP: 3
    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 VALCYTE
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Powder for oral solution
    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
    D.3.9.1CAS number 175865-60-8
    D.3.9.4EV Substance CodeSUB00007MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    cytomegalovirus infection in renal tranplant recipients
    Infección por citomegalovirus en receptores de un transplante renal
    E.1.1.1Medical condition in easily understood language
    cytomegalovirus infection in renal tranplant recipients
    Infección por citomegalovirus en receptores de un transplante renal
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10011831
    E.1.2Term Cytomegalovirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether the incidence of hCMV infection after renal transplantation in the group of patients without receiving prophylactic antiviral therapy (pre-emptive, A2 and B2 groups) will be significantly higher among those patients without hCMV-specific cellular response (memory / effector T cells against antigen hCMV IE-1) (group B2) compared to individuals with detectable hCMV-specific cellular response (group A2) using IFN-gamma ELISPOT technique
    Evaluar si la incidencia de infección por hCMV tras el transplante renal en el grupo de pacientes sin recibir terapia antiviral profiláctica (pre-emptive, grupos A2 y B2) será significativamente mayor entre aquellos pacientes sin respuesta celular hCMV-específica (células T memora/efectoras frente al antígeno IE-1 de hCMV) (grupo B2) en comparación con aquellos indivíduos con respuesta celular detectable hCMV-específica (grupo A2) mediante técnica de ELISPOT IFN-gamma antes del trasplante
    E.2.2Secondary objectives of the trial
    To evaluate-the incidence of late HCMV infection after Receiving prophylactic treatment for 3 months in the group of patients without T cell response memory / effector antigen against hCMV IE-1 (group B1) Compared to Individuals with positive ELISPOT (detection T cell memory / effector antigen against hCMV IE-1) (group A1).
    Assess the effect of type of preventive treatment in the group of patients With the same result of anti-hCMV Elispot.
    To Assess the Ability of spontaneous viral clearance in relation to the response of memory / hCMV-specific to each single EVALUATED by ELISPOT effector.
    To study the behavior in time of the response of hCMV-specific cellular memory (T) by the ELISPOT technique after transplantation under immunosuppressive therapy based on anti-regime clacineutínico Both in patients under antiviral prophylactic strategy or anticipated (Preemptive).
    Evaluar la incidencia de infección tardía por hCMV después de recibir tratamiento profiláctico durante 3 meses en el grupo de pacientes sin respuesta celular T memoria /efectoras frente al antígeno IE-1 de hCMV (grupo B1) en comparación con aquellos individuos con ELISPOT positivo (detección de células T memoria /efectoras frente al antígeno IE-1 de hCMV) (grupo A1).
    Evaluar el efecto del tipo de tratamiento preventivo dentro del grupo de pacientes con el mismo resultado del Elispot anti-hCMV.
    Evaluar la capacidad de aclaramiento viral espontáneo en relación a la respuesta de memoria/efectora hCMV-específica de cada individuo evaluada por técnica de ELISPOT.
    Estudiar el comportamiento en el tiempo de la respuesta de memoria hCMV-específica celular (T) mediante la técnica ELISPOT después del trasplante bajo terapia inmunosupresora basada en un régimen anti-clacineutínico, en pacientes tanto bajo estrategia profiláctica antiviral o anticipada (Preemptive).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects > 18 years old, both male and females, any race, with body weight >34 kg
    2. Subjects are hCMV positive and are due to receive a hCMV seropositive donor renal allograft
    3. Availability of receptor blood samples pre transplant to perform hCMV-specific ELISPOT determination.
    4. Subject is willing to participate in the study and has signed the Informed Consent Form. If a patient is unable to consent by writing, a legal representative is allowed to sign in his place.
    5. Women of Childbearing Potential must have a negative pregnancy test performed at the moment of inclusion and must accept the use of a reliable anticonceptive method during the lenght of the study
    1. Los sujetos deberán tener 18 años o más (y pesar más de 34Kg) y podrán ser de ambos sexos y de cualquier raza.
    2. Los sujetos serán seropositivos para el virus del hCMV y recibirán un injerto seropositivo (IgG positivo).
    3. Se dispone muestra de sangre pre-trasplante del receptor para la determinación del ELISPOT hCMV-específico.
    4. Los sujetos deberán estar dispuestos a otorgar su consentimiento informado por escrito para el ensayo y ser capaces de hacerlo. Si un sujeto no puede otorgar su consentimiento informado por escrito de forma independiente, podrá hacerlo su representante legal en su lugar.
    5. Las mujeres en edad fértil deberán realizar un test de embarazo en el momento de la inclusión y aceptar el uso de un método anticonceptivo médicamente aceptable durante el periodo de selección y mientras reciban la medicación especificada en el protocolo.
    E.4Principal exclusion criteria
    1. hCMV-specific ELISPOT test result indeterminate or lack of receptor blood sample to perform the test
    2. Subjects with a previously known tipe I hypersensibility or documented idiosyncratic reactions to ganciclovir(GCV)/valganciclovir(VGCV).
    3. Pregnant or lactating women.
    5. Any clinically significant disease that in the opinion of the investigator might interfere with the procedures of the trial
    6. Participation in another industry sponsored clinical trial that defines the treatment of CMV infection
    7. Other patients with no renal graft.
    8. Patients with active viral replication of HCV, HBV and / or HIV
    9. Treatment that is to receive maintenance immunosuppression including mTOR inhibitors.
    10. Patients requiring a desensitizing treatment including plasma exchange, Campath-1, Rituximab ®, Soliris ® and / or gamma globulin.
    1. Resultado del test de Elispot contra el hCMV no concluyente o falta de material del receptor.
    2. Los sujetos no podrán tener antecedentes de hipersensibilidad de tipo I ni de reacciones idiosincrásicas a los fármacos ganciclovir(GCV)/valganciclovir (VGCV).
    3. Mujeres embarazadas.
    4. Mujeres en periodo de lactancia.
    5. Los sujetos no podrán presentar ninguna enfermedad clínicamente significativa que pueda interferir en las evaluaciones del estudio.
    6. Participación en otro ensayo clínico promovido por industria farmacéutica, en el que el promotor ya establezca en el protocolo cual debe ser el tratamiento del CMV.
    7. Pacientes portadores de otro injerto no renal.
    8. Pacientes con replicación viral activa de los virus VHC, VHB y/o HIV
    9. Tratamiento que vaya a recibir immunosupresor de mantenimiento que incluya inhibidores de mTor.
    10. Pacientes que requieran de un tratamiento desensibilizador que incluya recambios plasmáticos, Campath-1, Rituximab®, Eculizumab® y/o Gammaglobulina.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of hCMV infection in patients receiving preemtive therapy in both positive and negative ELISPOT groups
    incidencia de infección por hCMV en pacientes que reciben tratamiento Preemptive en ambos grupos (ELISPOT positivo y negativo).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 MONTHS AND 12 MONTHS
    6 MESES Y 12 MESES
    E.5.2Secondary end point(s)
    Incidence of late hCMV infection in patients receiving prophylactic treatment in both positive and negative ELISPOT groups.
    Changes in hCMV-specific T cell immune response after transplantation and under immunosuppressant treatment by IFN-? ELISPOT technique
    Incidence of acute rejection episodes and its correlation with hCMV-specific ELISPOT test results performed before and after transplantation
    Incidence of valganciclovir-related Adverse Events
    Variables secundarias:
    La incidencia de infección por hCMV tardía en aquellos pacientes que reciben tratamiento profiláctico en ambos grupos (ELISPOT positivo y negativo).
    El cambio en la respuesta inmune hCMV-específica de tipo celular (T) tras el trasplante y bajo influencia de la inmunosupresión, medido mediante la técnica ELISPOT IFN-?.
    Incidencia de episodios de rechazo agudo y su posible relación con el resultado de la técnica ELISPOT IFN-? hCMV-específica medida antes y después del trasplante.
    Efectos adversos relacionados con el tratamiento con valganciclovir.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 MESES Y 12 MESES
    6 MESES Y 12 MESES
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    terapia preemptive
    preemtive therapy
    E.8.2.4Number of treatment arms in the trial4
    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
    LVLS
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years2
    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) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state160
    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 Decision2014-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
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