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    Summary
    EudraCT Number:2013-003831-31
    Sponsor's Protocol Code Number:8228-001
    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:2014-04-01
    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 number2013-003831-31
    A.3Full title of the trial
    A Phase III Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-8228 (Letermovir) for the Prevention of Clinically Significant Human Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients
    Ensayo Clínico de Fase III, Randomizado, Controlado con Placebo para Evaluar la Seguridad y Eficacia de MK 8228 (letermovir) en la Prevención de la Infección Clínicamente Significativa por Citomegalovirus (CMV) en Adultos CMV Seropositivos que vayan a Recibir un Trasplante Alogénico de Células Madre Hematopoyéticas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MK-8228 vs. Placebo in Prevention of CMV infection in HSCT Recipients
    MK 8228 frente a placebo en la prevención de la infección por CMV en receptores de un TCMH
    A.3.2Name or abbreviated title of the trial where available
    MK-8228 vs. Placebo in Prevention of CMV infection in HSCT Recipients
    MK 8228 frente a placebo en la prevención de la infección por CMV en receptores de un TCMH
    A.4.1Sponsor's protocol code number8228-001
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/11/849
    D.3 Description of the IMP
    D.3.1Product nameLetermovir
    D.3.2Product code MK-8228
    D.3.4Pharmaceutical form Film-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 INNLetermovir
    D.3.9.1CAS number 917389-32-3
    D.3.9.2Current sponsor codeMK-8228
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/11/849
    D.3 Description of the IMP
    D.3.1Product nameLetermovir
    D.3.2Product code MK-8228
    D.3.4Pharmaceutical form Solution for 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 INNLetermovir
    D.3.9.1CAS number 917389-32-3
    D.3.9.2Current sponsor codeMK-8228
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Clinically significant CMV infection
    Infección clínicamente significativa por CMV
    E.1.1.1Medical condition in easily understood language
    Clinically significant CMV infection
    Infección clínicamente significativa por CMV
    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
    To evaluate the efficacy of MK-8228 in the prevention of clinically significant CMV infection through Week 24 (~6 months) post-transplant following administration of MK-8228 or placebo.
    Evaluar la eficacia de MK 8228 en la prevención de la infección clínicamente significativa por CMV hasta la semana 24 (unos 6 meses) después del trasplante tras la administración de MK 8228 o placebo.
    E.2.2Secondary objectives of the trial
    1) To evaluate the safety and tolerability of MK-8228.
    2) To evaluate the efficacy of MK-8228 in the prevention of clinically significant CMV infection through Week 14 (~100 days) post-transplant.
    3) To evaluate the efficacy of MK-8228 as assessed by time to onset of clinically significant CMV infection through Week 24 (~6 months) post-transplant.
    4) To determine the incidence of CMV disease through Week 14 post -transplant and Week 24 post-transplant.
    5) To assess the incidence of PET for CMV viremia through Week 14 post-transplant and Week 24 post-transplant.
    6) To assess the time to initiation of PET for CMV viremia through Week 14 post-transplant and Week 24 post-transplant.
    1) Evaluar la seguridad y la tolerabilidad de MK 8228.
    2) Evaluar la eficacia de MK 8228 en la prevención de la infección clínicamente significativa por CMV hasta la semana 14 (unos 100 días) después del trasplante.
    3) Evaluar la eficacia de MK 8228, determinada mediante el tiempo transcurrido hasta la aparición de una infección clínicamente significativa por CMV, hasta la semana 24 (unos 6 meses) después del trasplante.
    4) Determinar la incidencia de enfermedad por CMV hasta las semanas 14 y 24 después del trasplante.
    5) Evaluar la incidencia de TP según la viremia por CMV hasta las semanas 14 y 24 después del trasplante.
    6) Evaluar el tiempo transcurrido hasta el inicio del TP según la viremia por CMV hasta las semanas 14 y 24 después del trasplante.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    Merck realizará investigaciones biomédicas futuras en muestras de ADN (sangre) recogidas durante este ensayo clínico. Esta investigación consiste en un estudio de biomarcadores para estudiar aspectos que no estén descritos en el protocolo (como parte del estudio principal) y sólo se realizarán en los pacientes que hayan consentido. El objetivo de la recogida de muestras para investigación biomédica futura es explorar e identificar biomarcadores que ayuden a entender las enfermedades y sus tratamientos. El objetivo global es utilizar dicha información para desarrollar medicamentos más seguros y efectivos y asegurar que los pacientes reciben la dosis correcta de medicación en el momento correcto.
    E.3Principal inclusion criteria
    1. be > or = to 18 years of age on the day of signing informed consent.
    2. have documented seropositivity for CMV (recipient CMV IgG seropositivity [R+]) within 1 year before HSCT.
    3. be receiving a first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant).
    4. have undetectable CMV DNA (as confirmed by the central laboratory) from a plasma sample collected within 5 days prior to randomization.
    5. be within 28 days post-HSCT at the time of randomization.
    6. be highly unlikely to become pregnant or to impregnate a partner
    1. Tener una edad mínima de 18 años el día de la firma del consentimiento informado.
    2. Tener seropositividad documentada para CMV (seropositividad de IgG contra el CMV en el receptor [R+]) en el año previo al TCMH.
    3. Ir a recibir un primer TCMH alogénico (médula ósea, células madre de sangre periférica o trasplante de sangre de cordón).
    4. Tener un valor indetectable de ADN del CMV (confirmado por el laboratorio central) en una muestra de plasma obtenida en los 5 días anteriores a la aleatorización.
    5. Encontrarse en los 28 días posteriores al TCMH en el momento de la aleatorización.
    6. Tener muy escasa probabilidad de quedarse embarazada o de dejar embarazada a su pareja.
    E.4Principal exclusion criteria
    1. received a previous allogeneic HSCT
    2. has a history of CMV end-organ disease within 6 months prior to randomization.
    3. has evidence of CMV viremia from a central or local laboratory at any time prior to randomization.
    4. received within 7 days prior to screening or plans to receive during the study any of the following: ganciclovir; valganciclovir; foscarnet; acyclovir (at doses > 3200 mg PO per day or > 25 mg/kg IV per day); valacyclovir (at doses > 3000 mg PO per day); famciclovir (at doses > 1500 mg PO per day)
    5. received within 30 days prior to screening or plans to receive during the study any of the following: cidofovir; CMV hyper-immune globulin; Any investigational CMV antiviral agent/biologic therapy
    6. has severe hepatic insufficiency within 5 days prior to randomization.
    7. has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 x the upper limit of normal (ULN) or serum total bilirubin > 2.5 x ULN within 5 days prior to randomization.
    8. has end-stage renal impairment with a creatinine clearance less than 10 mL/min, as calculated by the Cockcroft-Gault equation using serum creatinine within 5 days prior to randomization.
    9. has an uncontrolled infection on the day of randomization.
    10. requires mechanical ventilation or is hemodynamically unstable at the time ofrandomization.
    11. has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
    1. Hayan recibido un TCMH alogénico previo.
    2. Tengan antecedentes de enfermedad orgánica por CMV en los 6 meses previos a la aleatorización.
    3. Presenten datos de viremia por CMV según un laboratorio central o local en cualquier momento antes de la aleatorización.
    4. Hayan recibido en los 7 días previos a la selección o tengan previsión de recibir durante el estudio alguno de los fármacos siguientes:
    -ganciclovir
    -valganciclovir
    -foscarnet
    -aciclovir (en dosis > 3200 mg al día por vía oral o 25 mg/kg al día por vía IV)
    -valaciclovir (en dosis > 3000 mg al día por vía oral)
    -famciclovir (en dosis > 1500 mg al día por vía oral)
    5. Hayan recibido en los 30 días previos a la selección o tengan previsión de recibir durante el estudio alguno de los fármacos siguientes:
    -cidofovir
    -hiperinmunoglobulina contra el CMV
    -cualquier antiviral/tratamiento biológico contra el CMV en investigación
    6. Presenten insuficiencia hepática grave en los 5 días anteriores a la aleatorización.
    7. Presenten una concentración sérica de aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) > 5 veces el límite superior de la normalidad (LSN) o de bilirrubina total > 2,5 veces el LSN en los 5 días anteriores a la aleatorización.
    8. Presenten insuficiencia renal terminal con un aclaramiento de creatinina inferior a 10 ml/min, calculado mediante la ecuación de Cockcroft Gault con la creatinina sérica, en los 5 días anteriores a la aleatorización.
    9. Presenten una infección no controlada el día de la aleatorización.
    10. Precisen ventilación mecánica o presenten inestabilidad hemodinámica en el momento de la aleatorización.
    11. Hayan participado previamente o estén participando en la actualidad en un estudio que suponga la administración de una vacuna contra el CMV u otro fármaco experimental contra el CMV o que tengan previsto participar en un estudio de una vacuna contra el CMV u otro fármaco experimental contra el CMV durante este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of the study is the proportion of subjects with clinically significant CMV infection through Week 24 (~6 months) post-transplant, defined as the occurrence of either one of the following outcomes:
    onset of CMV end-organ disease
    OR
    initiation of anti-CMV PET based on documented CMV viremia (as measured by the central laboratory) and the clinical condition of the subject. Initiation of PET in this study refers to the practice of initiating therapy with the following approved anti-CMV agents when active CMV viral replication is documented: ganciclovir, valganciclovir, foscarnet, and/or cidofovir.
    El criterio de valoración principal de la eficacia del estudio será la proporción de sujetos con infección clínicamente significativa por CMV hasta la semana 24 (unos 6 meses) después del trasplante, definida como la aparición de cualquiera de las circunstancias siguientes:
    Aparición de enfermedad orgánica por CMV.
    O BIEN
    Inicio de un TP contra el CMV basándose en la viremia por CMV documentada (medida por el laboratorio central) y la situación clínica del sujeto. El inicio de un TP en este estudio se refiere a la práctica de iniciar tratamiento con los siguientes fármacos aprobados contra el CMV al confirmar la existencia de replicación activa del CMV: ganciclovir, valganciclovir, foscarnet o cidofovir.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24 (~6 months) post- HSCT transplant
    semana 24 (unos 6 meses) después del trasplante de TCMH
    E.5.2Secondary end point(s)
    1. Proportion of subjects with clinically significant CMV infection through Week 14 (~100 days) post-transplant
    2. Time to onset of clinically significant CMV infection through Week 24 (~6 months) post-transplant
    3. Proportion of subjects with CMV disease through Week 14 post-transplant and Week 24 post-transplant
    4. Proportion of subjects with initiation of PET for documented CMV viremia through Week 14 post-transplant and Week 24 post-transplant.
    5. The time to initiation of PET for documented CMV viremia through Week 24 post-transplant.
    1. Proporción de sujetos con infección clínicamente significativa por CMV hasta la semana 14 (unos 100 días) después del trasplante.
    2. Tiempo transcurrido hasta la aparición de una infección clínicamente significativa por CMV hasta la semana 24 (unos 6 meses) después del trasplante.
    3. Proporción de sujetos con enfermedad por CMV hasta las semanas 14 y 24 después del trasplante.
    4. Proporción de sujetos con inicio del TP por viremia por CMV documentada hasta las semanas 14 y 24 después del trasplante.
    5. Tiempo transcurrido hasta el inicio del TP por viremia por CMV documentada hasta la semana 24 después del trasplante.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 14, Week 24
    Semana 12, Semana 24
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Finland
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Lithuania
    New Zealand
    Peru
    Poland
    Romania
    Spain
    Sweden
    Turkey
    United Kingdom
    United States
    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
    LVLS
    LVLS
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 540
    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)
    Subjects will receive local standard of care
    Los sujetos recibiran el tratamiento estandar
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Group for Blood and Marrow Transplantation
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-21
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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