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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:2005-002817-19
    Sponsor's Protocol Code Number:NT18435
    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:2005-12-29
    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 number2005-002817-19
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo que compara la eficacia y seguridad de valganciclovir administrado durante 100 días frente a valganciclovir administrado durante 200 días en la prevención de enfermedad por citomegalovirus en pacientes receptores de alto riesgo de aloinjerto renal
    A.4.1Sponsor's protocol code numberNT18435
    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 SponsorF Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Valcyte
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Farma, S.A.
    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.3.1Product nameValcyte
    D.3.2Product code Ro 107-9070
    D.3.4Pharmaceutical form Film-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 INNValganciclovir
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    Prevención de enfermedad por citomegalovirus en pacientes receptores de alto riesgo de aloinjerto renal
    Prevention of cytomegalovirus (CMV) disease in kidney transplant recipients
    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
    1. Comparar la eficacia de valganciclovir profiláctico (900 mg una vez al día) administrado durante 100 días frente a valganciclovir profiláctico (900 mg una vez al día) administrado durante 200 días, en la prevención de enfermedad por CMV en pacientes receptores de alto riesgo de aloinjerto renal (D+/R-). La variable principal de valoración del estudio será la proporción de pacientes que desarrollen enfermedad por CMV durante las 52 primeras semanas (12 meses) post-transplante.
    2. Comparar la seguridad de valganciclovir profiláctico (900 mg una vez al día) administrado durante hasta 100 días frente a valganciclovir profiláctico (900 mg una vez al día) administrado durante 200 días, en la prevención de enfermedad por CMV pacientes receptores de alto riesgo de aloinjerto renal (D+/R-)
    E.2.2Secondary objectives of the trial
    1. La proporción de pacientes con enfermedad por CMV (en momentos puntuales aparte de los 12 meses post-transplante).
    2. El tiempo transcurrido hasta la enfermedad por CMV.
    3. La proporción de pacientes con viremia por CMV.
    4. El tiempo transcurrido hasta la viremia por CMV.
    5. La proporción de pacientes que experimenten rechazo agudo confirmado por biopsia (RACB).
    6. La proporción de pacientes con pérdida del injerto.
    7. La proporción de pacientes sobrevivientes.
    8. La proporción de pacientes con infecciones oportunistas (IOs).
    9. La proporción de pacientes con seroconversión.
    10. El tiempo transcurrido hasta la seroconversión.
    11. La proporción de pacientes con CMV que demuestre cambios genotípicos asociados al desarrollo de la resistencia del CMV a ganciclovir.
    12. La proporción de pacientes que experimenten diabetes mellitus post-transplante (DMPT).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. El paciente haya recibido en los 10 días anteriores un aloinjerto renal vivo o cadáver primario o secundario.
    2. El paciente sea seronegativo para CMV (confirmado durante los 30 días anteriores al transplante) y ha recibido un aloinjerto de un donante CMV-positivo. A efectos de este estudio, cualquier donante supuestamente seropositivo en base únicamente a la administración inmediatamente anterior a la donación de órganos de una transfusión seropositiva para CMV, no se considerará como donante seropositivo.
    3. La edad del paciente sea >16 años.
    4. El paciente presente una función hematológica y renal post-transplante adecuada, definida como:

    a. Recuento absoluto de neutrófilos (RAN) >1000 células/µL
    b. Recuento de plaquetas >25.000 células/µL
    c. Hemoglobina >8,0 g/dL
    d. Aclaramiento de creatinina estimado (calculado de acuerdo con la fórmula Cockcroft-Gault) de >15 mL/min con evidencia de una evolución favorable de la función renal.

    5. Las mujeres en edad fértil deberán presentar una prueba de embarazo negativa en la selección.
    6. Las pacientes femeninas en edad fértil y los pacientes masculinos con parejas en edad fértil se comprometen a mantener un método anticonceptivo eficaz durante los 90 días posteriores a la suspensión de la medicación de estudio
    7. El paciente deberá ser capaz de tolerar e iniciar la administración de la medicación por vía oral en los 10 días posteriores al transplante. El día de finalización de la cirugía de transplante se definirá como el Día 0.
    8. El paciente entienda el consentimiento informado y firme el mismo.
    E.4Principal exclusion criteria
    1. Exista una sospecha de que el paciente tiene enfermedad por CMV.
    2. El paciente haya recibido tratamiento anti-CMV durante los 30 días anteriores a la selección. (Se podrán utilizar aciclovir, valaciclovir o famciclovir durante un período máximo de 10 días, a la dosis especificada en el prospecto, para el tratamiento de herpes simple o herpes zóster agudo).
    3. El paciente haya recibido un transplante multiórgano (por ej., hígado o páncreas, además del riñón).
    4. El paciente haya recibido un fármaco nuevo en vías de investigación durante los 30 días previos, a no ser que esté aprobado por el representante de Roche Medical Science.
    5. El paciente participe simultáneamente en otro ensayo clínico, a no ser que esté aprobado por un representante de Roche Medical Science.
    6. El paciente presente diarrea grave, no controlada (múltiples deposiciones sueltas) o evidencia de malabsorción.
    7. El paciente haya demostrado en el pasado una reacción alérgica u otra reacción adversa significativa a aciclovir, valaciclovir, ganciclovir o valganciclovir.
    8. El paciente requiera el uso de cualquier medicación prohibida.
    9. La paciente es una mujer en período de lactancia que no suspenderá la lactancia antes del inicio del estudio.
    10. El paciente presente resultados de las pruebas de función hepática superiores a 3 veces el límite superior normal (LSN).
    11. El paciente sea un portador conocido del Virus de la Inmunodeficiencia Humana (VIH), de la Hepatitis B (VHB; HBs Ag positivo) o de la Hepatitis C (VHC; anti-VHC Ac positivo).
    12. Pacientes con neoplasias o antecedentes de neoplasias, a excepción de carcinoma de las células basales o escamosas de la piel no-metastático y tratado con éxito.
    13. Pacientes masculinos cuya pareja esté embarazada.
    14. Pacientes que abusen de sustancias, que presenten algún trastorno psiquiátrico o médico grave que, en opinión del Investigador, podría producir el incumplimiento, invalidar la comunicación con el Investigador o complicar el manejo del paciente (por ej., epilepsia, trastorno bipolar, etc..).
    15. Sea poco probable que el paciente esté disponible durante el curso entero del estudio (104 semanas).
    E.5 End points
    E.5.1Primary end point(s)
    La proporción de pacientes que desarrollen enfermedad por CMV (definida como síndrome de CMV o enfermedad tejido invasiva por CMV) durante los 12 primeros meses post-transplante.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Valganciclovir
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Última visita, último paciente
    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 months0
    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 months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 316
    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)
    Los pacientes recibirán tratamiento de acuerdo a la práctica terapéutica habitual del centro, una vez finalice el ensayo o en el caso de que un paciente discontinúe prematuramente. Adicionalmente, los pacientes que desarrollen CMV durante el ensayo recibirán tratamiento de acuerdo a la práctica habitual del centro.
    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 Decision2006-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-08-13
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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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