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    Summary
    EudraCT Number:2007-004729-16
    Sponsor's Protocol Code Number:1263-301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-20
    Trial results View 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 number2007-004729-16
    A.3Full title of the trial
    UN ESTUDIO ALEATORIZADO, DOBLE CIEGO PARA EVALUAR LA EFICACIA Y SEGURIDAD DEL USO PROFILÁCTICO DE MARIBAVIR FRENTE A GANCICLOVIR ORAL PARA LA PREVENCIÓN DE LA ENFERMEDAD POR CITOMEGALOVIRUS EN RECEPTORES DE TRASPLANTES ORTOTÓPICOS DE HÍGADO

    A RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR VERSUS ORAL GANCICLOVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECIPIENTS OF ORTHOTOPIC LIVER TRANSPLANTS
    A.4.1Sponsor's protocol code number1263-301
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorViroPharma Incorporated
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameMaribavir
    D.3.2Product code VP 41263
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNMARIBAVIR
    D.3.9.1CAS number 176161243
    D.3.9.2Current sponsor codeVP 41263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 RoleComparator
    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 Ganciclovir 500mg Capsules (NDC # 63304-637-28) Abbreviated New Drug Application (ANDA) # 076457
    D.2.1.1.2Name of the Marketing Authorisation holderRanbaxy Pharmaceuticals, Inc; Princeton, NJ 08540 USA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGanciclovir
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNGANCICLOVIR
    D.3.9.1CAS number 82410320
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Evaluar la eficacia y seguridad del uso profiláctico de maribavir frente a ganciclovir oral para la prevención de la enfermedad por citomegalovirus en receptores de trasplantes ortotópicos de hígado.

    Main purpose is to assess the efficacy and safety of prophylactic use of oral Maribavir versus oral Ganciclovir to prevent cytomegalovirus disease in recipients of orthotopic liver transplants at high risk of developing CMV disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009701
    E.1.2Term CMV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la eficacia del uso profiláctico de maribavir frente a ganciclovir oral cuando se administran durante hasta 14 semanas para la prevención de la enfermedad por citomegalovirus en receptores de trasplantes ortotópicos de hígado con alto riesgo de desarrollar enfermedad por CMV

    The main objective of this study is to compare the efficacy of the prophylactic use of oral maribavir versus oral ganciclovir when administered for up to 14 weeks for the prevention of cytomegalovirus disease in recipients of orthotopic liver transplants at high risk developing CMV disease.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son comparar la seguridad y tolerancia del uso profiláctico de maribavir frente a ganciclovir oral cuando se administran durante hasta 14 semanas en esta población de sujetos y evaluar la farmacocinética de maribavir en esta población de sujetos.

    Secondary objectives of this study are to compare the safety and tolerability of the prophylactic use of oral maribavir versus oral ganciclovir when administered for up to 14 weeks in recipients of orthotopic liver transplants at high risk developing CMV disease and to evaluate the pharmacokinetics of maribavir in this subject population.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Igual que el título del protocolo.
    El objetivo del subestudio es evaluar la farmacocinética de maribavir, se realizará en algunos centros seleccionados. Ningun centro de España ni de la UE participarán del subestudio.
    Los detalles del subestudio estan descritos en la página 48 y el Apéndice IX del protocolo.
    E.3Principal inclusion criteria
    Los sujetos deben:
    1.Estar informados de la naturaleza del estudio y proporcionar el consentimiento informado por escrito antes de que se realice cualquier procedimiento específico del estudio.
    2.Tener > 18 años de edad.
    3.Pesar > 40 kg.
    4.Someterse a su primer trasplante ortotópico hígado (el injerto trasplantado puede ser un órgano entero de donante fallecido, un injerto parcial de hígado de donante fallecido o un injerto de donante vivo).
    5.Tener una serología negativa para CMV antes del trasplante y recibir un hígado de un donante con serología positiva para CMV antes del trasplante (es decir, donante positivo / receptor negativo [D+ R–]).
    6.No tener infección por CMV detectable tras el trasplante. Esto debe documentarse mediante pruebas de CMV en sangre usando o bien el ensayo de antigenemia de pp65 de CMV, PCR de ADN de CMV u otro ensayo de detección de ADN de CMV de una muestra recogida tras el trasplante. Pueden usarse los resultados o bien del laboratorio central o bien de un laboratorio local para ver si cumplen los requisitos.
    7.Tener los siguientes hallazgos como parte de las evaluaciones clínicas de selección (pueden usarse los resultados o bien del laboratorio central o bien de un laboratorio local para ver si cumplen los requisitos):
    •Recuento absoluto de neutrófilos (RAN) ≥ 500/mm3 [0,5 x 109/L]
    •Recuento plaquetario ≥ 25.000/mm3 [25 x 109/L]
    8.Aleatorizarse de manera que la dosificación con fármaco del estudio pueda comenzar en el plazo de 10 días tras el trasplante.
    9.Si es mujer, o bien ser posmenopáusica, quirúrgicamente estéril o bien tener una prueba de embarazo en suero negativa como parte de las evaluaciones clínicas de selección. Las mujeres en edad de procrear también deben acceder a usar un método aceptable de control de la natalidad (por ejemplo, abstinencia, DIU o método de barrera), según se determine por el investigador, durante el periodo de administración del fármaco del estudio y durante 3 meses después de eso. No deben usarse anticonceptivos hormonales como el único método de control de la natalidad.
    Si es hombre, debe acceder a usar un método aceptable de control de la natalidad (por ejemplo, abstinencia o método de barrera), según se determine por el investigador, durante el periodo de administración del fármaco del estudio y durante 3 meses después de eso.
    10.Poder tragar comprimidos y cápsulas.
    E.4Principal exclusion criteria
    Los sujetos no deben:
    1.Estar sometiéndose a trasplante de múltiples órganos o haberse sometido a un trasplante de órgano anterior (excepto piel, pelo o córnea).
    2.Tener una infección conocida por virus de inmunodeficiencia humano (VIH) (basándose en pruebas realizadas durante el procedimiento de evaluación del trasplante o durante la selección para este estudio).
    3.Tener una enfermedad de órgano relacionada con CMV en el plazo de los 6 meses anteriores al día de la inclusión.
    4.Estar recibiendo cualquiera de los siguientes tratamientos en el momento de la inclusión:
    •ganciclovir
    •valganciclovir
    •foscarnet
    •cidofovir
    •aciclovir (> 25 mg/kg i.v al día)
    •valaciclovir (> 3 g v.o. al día)
    •famciclovir (> 1500 mg v.o. al día)
    NOTA: Un sujeto puede haber recibido cualquiera de los fármacos enumerados anteriormente antes de la inclusión. Si es el caso, deben suspenderse estos fármacos en el momento de la inclusión; no se requiere ningún periodo de “lavado” mínimo antes de comenzar la dosificación con fármacos del estudio.
    5.Haber recibido inmunoglobulina frente a citomegalovirus en el plazo de los 30 días anteriores al día de la inclusión.
    6.Estar recibiendo tratamiento con fenitoína en el momento de la inclusión.
    7.Tener un aclaramiento de creatinina estimado < 10 mL/min o requerir diálisis en el momento de la inclusión.
    8.Tener vómitos graves, diarrea u otras enfermedades gastrointestinales graves en el plazo de las 24 horas anteriores al momento de la inclusión que descartarían la administración de medicación oral.
    9.Requerir ventilación mecánica o vasopresores para apoyo hemodinámico en el momento de la inclusión.
    10.Estar embarazada (según se determina mediante pruebas de B-hCG antes del inicio del fármaco del estudio) o en periodo de lactancia.
    11.Haber recibido cualquier agente antiviral en investigación o agente inmunosupresor en investigación en el plazo de 30 días antes del inicio del fármaco del estudio.
    12.Haber recibido maribavir en un ensayo clínico anterior.
    13.Tener cualquier estado quirúrgico o médico clínicamente significativo (distinto del motivo subyacente para el trasplante) que en opinión del investigador o el promotor comprometería el desenlace del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración primario de eficacia es la incidencia de enfermedad por CMV (tanto infección por CMV sintomática como enfermedad de órgano por CMV, según lo juzga un comité de criterio de valoración independiente) en el plazo de 6 meses tras el trasplante. La incidencia de enfermedad por CMV también se evaluará en el plazo de 100 días y 12 meses tras el trasplante.
    Las poblaciones de análisis incluyen: ITT (intención de tratar, todos los sujetos aleatorizados al tratamiento); ITT-S (intención de tratar-Seguridad, todos los sujetos de ITT que recibieron al menos una dosis de medicación del estudio); e ITT-E (evaluable para CMV, todos los sujetos de ITT-S con ensayos negativos de CMV al comienzo del tratamiento con fármaco del estudio).
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 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) Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 348
    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)
    Todo sujeto incluido en el estudio continuará siendo controlado por su respetivo médico, mediante la práctica clínica habitual. No requiere procedimientos especiales ni cuidados médicos extra una vez finalizado el ensayo que difieran de los utilizados en pacientes que no hayan participado del estudio.
    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 Decision2008-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-14
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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