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    Summary
    EudraCT Number:2015-004725-13
    Sponsor's Protocol Code Number:SHP620-303
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-004725-13
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to
    Assess the Efficacy and Safety of Maribavir Treatment Compared to
    Investigator-assigned Treatment in Transplant Recipients with
    Cytomegalovirus (CMV) Infections that are Refractory or Resistant to
    Treatment with Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir.
    Studio di Fase 3, multicentrico, randomizzato, in aperto, con controllo attivo per valutare l'efficacia e la sicurezza del trattamento con Maribavir rispetto al trattamento assegnato dallo Sperimentatore in riceventi di trapianto affetti da infezioni da Citomegalovirus (CMV) refrattarie o resistenti al trattamento con Ganciclovir, Valganciclovir, Foscarnet, o Cidofovir
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study to determine how safe and effective maribavir versus standard of
    care is in treating cytomegalovirus in transplant patients
    Studio per stabilire la sicurezza e l'efficacia di maribavir rispetto allo standard di cura nel trattamento del citomegalovirus in pazienti sottoposti a trapianto
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberSHP620-303
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:SHP620-303Number:-
    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 SponsorSHIRE HUMAN GENETIC THERAPIES, 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 supportShire ViroPharma Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire
    B.5.2Functional name of contact pointKaren Hager
    B.5.3 Address:
    B.5.3.1Street Address300 Shire Way
    B.5.3.2Town/ cityLexington MA
    B.5.3.3Post code02 421
    B.5.3.4CountryUnited States
    B.5.4Telephone number7814820884
    B.5.5Fax number6178037298
    B.5.6E-mailkhager@shire.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/3/13/1133
    D.3 Description of the IMP
    D.3.1Product nameMaribavir
    D.3.2Product code SHP620
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMARIBAVIR
    D.3.9.1CAS number 176161-24-3
    D.3.9.2Current sponsor codeSHP620
    D.3.9.3Other descriptive nameinibitore Serina/Treonina Chinasi
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 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 VALCYTE - 60 COMPRESSE RIVESTITE CON FILM DA 450 MG IN BOTTIGLIA
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVALGANCICLOVIR CLORIDRATO
    D.3.9.1CAS number 175865-59-5
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameVALGANCICLOVIR CLORIDRATO
    D.3.9.4EV Substance CodeSUB16471MIG
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 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 FOSCAVIR - 24 MG/ML SOLUZIONE PER INFUSIONE 1 FLACONE 250 ML
    D.2.1.1.2Name of the Marketing Authorisation holderCLINIGEN HEALTHCARE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameFoscavir
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFOSCARNET
    D.3.9.1CAS number 63585-09-1
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB02258MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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: 4
    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 CYMEVENE - 500 MG/10 ML POLVERE E SOLVENTE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO POLVERE + 1 FIALA SOLVENTE DA 10 ML
    D.2.1.1.2Name of the Marketing Authorisation holderRoche S.p.A
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameCymevene
    D.3.2Product code -
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameGANCICLOVIR
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    CMV infections resistant or refractory in transplant patients
    Infezioni da CMV resistenti o refrattarie in pazienti sottoposti a trapianto
    E.1.1.1Medical condition in easily understood language
    CMV infections resistant or refractory in transplant patients
    Infezioni da CMV resistenti o refrattarie in pazienti sottoposti a trapianto
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021829
    E.1.2Term Infection in solid organ transplant recipients
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021819
    E.1.2Term Infection in marrow transplant recipients
    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 compare the efficacy of maribavir to investigator-assigned anti CMV
    therapy in CMV viremia clearance after 8-week treatment in transplant
    recipients who are refractory or resistant to prior anti-CMV treatment.
    Mettere a confronto l'efficacia di maribavir rispetto alla terapia anti-CMV assegnata dallo sperimentatore nella clearance della viremia da CMV dopo un trattamento di 8 settimane in soggetti che hanno ricevuto trapianto refrattari o resistenti a precedente trattamento anti-CMV.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of the 2 study treatment arms on CMV viremia
    clearance and tissue invasive CMV disease improvement or resolution
    after 8-week treatment and maintenance of this treatment effect
    through Study Week 16 (8 weeks of post-treatment/follow-up phase)
    Mettere a confronto l'efficacia di 2 bracci di trattamento in studio sulla clearance della viremia da CMV e sul miglioramento o la risoluzione di malattia invasiva tissutale da CMV dopo un trattamento di 8 settimane e mantenimento di questo effetto di trattamento fino alla Settimana dello studio 16 (8 settimane di fase di follow-up/post-trattamento)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Be able to provide written, personally signed, and dated informed consent to participate in the study beforecompleting any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the subject before completing any study-related procedures.
    2. Be a recipient of hematopoietic stem cell or solid organ transplant
    3.Have a documented CMV infection in whole blood or plasma, with a screening value of ≥2730 IU/mL in whole blood or ≥910IU/ml in plasma in 2 consecutive assessments, separated by at
    least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable
    quantitative CMV DNA results. Both samples should be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. Same laboratory and same sample type (whole blood or plasma) should be used for these assessments.
    4.Have a current CMV infection refractory or resistant to treatment. Refractory is defined as documented failure to achieve >1 log10
    decrease in CMV DNA level in whole blood or plasma after 2 or more weeks of treatment with IV ganciclovir, oral valganciclovir, IV foscarnet, or IV
    cidofovir (or any combination thereof). Resistant is defined as documented failure to achieve >1 log10 (common logarithm to base 10) decrease in CMV DNA level in whole blood or plasma after an interval of 2 or more weeks of treatment with IV ganciclovir, oral valganciclovir, IV foscarnet, or IV cidofovir (or any combination thereof) AND
    documentation of 1 or more CMV genetic mutations associated with resistance to ganciclovir, valganciclovir, foscarnet, or cidofovir.
    5.Per investigator's judgment, be eligible for treatment with at least 1 of the available anti-CMV therapy (ganciclovir, valganciclovir, foscarnet, or
    cidofovir)
    6.Be ≥12 years of age at the time of consent
    7.Weight ≥35 kg
    8.Have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification):
    a.Absolute neutrophil count (ANC) ≥1000/mm3 [1.0 x 109/L]
    b.Platelet count ≥25000/mm3 [25 x 109/L]
    c.Hemoglobin ≥8g/dL
    d.Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2 as assessed by Modification of Diet in Renal Disease (MDRD) formula for
    subjects ≥18 years of age or Schwartz formula for subjects <18 years of age.
    9.All females of child bearing potential must have a negative serum β-human chorionic gonadotropin (β-HCG) pregnancy test at screening. Sexually active females of child bearing potential must agree
    to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment
    administration period and for 90 days afterward if treated with maribavir, ganciclovir, valganciclovir, or cidofovir and for 180 days afterward if treated with foscarnet.
    10.Be able to swallow tablets
    11.Be willing and have an understanding and ability to fully comply with
    study procedures and restrictions defined in the protocol
    12.Be willing to provide necessary samples (eg, biopsy) for the diagnosis of tissue invasive CMV disease at baseline as determined by the
    investigator
    13.Life expectancy of ≥8 weeks
    1.Essere in grado di fornire consenso informato scritto alla partecipazione allo studio, firmato e datato personalmente prima del completamento di qualsiasi procedura correlata allo studio. Se pertinente, un genitore/entrambi i genitori o il rappresentante legale autorizzato (LAR) devono fornire la firma del consenso informato e deve esserci la documentazione di assenso da parte del soggetto prima di completare qualsiasi procedura dello studio.
    2.Aver ricevuto trapianto di cellule staminali emopoietiche o trapianto di organo solido
    3.Presentare un'infezione documentata da CMV con un valore allo screening di ≥2730 IU/mL nel sangue intero, o ≥910 IU/ml nel plasma, in 2 valutazioni consecutive separate da almeno 1 giorno come stabilito dalla reazione a catena della polimerasi quantitativa dal laboratorio specialistico centrale o locale (qPCR) o risultati di analisi del DNA di CMV quantitative paragonabili. Entrambi i campioni devono essere prelevati entro 14 giorni prima della randomizzazione e il secondo campione deve essere ottenuto entro 5 giorni prima della randomizzazione. Per queste valutazioni deve essere utilizzato il medesimo laboratorio e il medesimo tipo di campione (sangue intero o plasma).
    4.Presentare un'attuale infezione da CMV refrattaria o resistente al trattamento. Refrattario si definisce come mancato raggiungimento documentato di una diminuzione >1 log10 del livello del DNA di CMV nel sangue intero o nel plasma dopo 2 o più settimane di trattamento con ganciclovir EV, valganciclovir orale, foscarnet EV, o cidofovir EV (o qualsiasi combinazione di questi). Resistente si definisce come mancato raggiungimento documentato di una diminuzione >1 log10 (logaritmo comune in base 10) del livello del DNA di CMV nel sangue intero o nel plasma dopo un intervallo di 2 o più settimane di trattamento con ganciclovir EV, valganciclovir orale, foscarnet EV, o cidofovir EV (o qualsiasi combinazione di questi) E documentazione di 1 o più mutazioni genetiche di CMV associate a resistenza a ganciclovir, valganciclovir, foscarnet, o cidofovir.
    5.A giudizio dello sperimentatore, essere eleggibile per il trattamento con almeno 1 dei farmaci anti-CMV disponibili (ganciclovir, valganciclovir, foscarnet, o cidofovir)
    6.Avere ≥ 12 anni al momento del consenso
    7.Peso ≥ 35 kg
    8.Presentare tutti i seguenti risultati nell'ambito delle valutazioni di laboratorio di screening (per la qualificazione possono essere usati risultati del laboratorio centrale o di un laboratorio locale):
    a. Conta assoluta dei neutrofili (ANC) ≥1000/mm3 [1,0 x 109/L]
    b. Conta piastrinica ≥25000/mm3 [25 x 109/L]
    c. Emoglobina ≥ 8g/dL
    d. Velocità di filtrazione glomerulare stimata (eGFR) >30 mL/min/1,73m2 valutata in base alla Formula di modificazione della dieta nella malattia renale (MDRD) per i soggetti ≥18 anni di età o alla formula di Schwartz per i soggetti <18 anni di età.
    9.Tutte le donne in età fertile devono presentare un test di gravidanza su siero negativo per la gonadotropina corionica umana β (β hCG) allo screening. Le donne sessualmente attive in età fertile devono accettare di aderire ai requisiti di contraccezione applicabili previsti dal protocollo. Se di sesso maschile, il soggetto deve accettare di usare un metodo contraccettivo accettabile, come definito nel protocollo, durante il periodo di somministrazione del trattamento in studio e successivamente per 90 giorni se trattato con maribavir, ganciclovir, o cidofovir e per 180 giorni successivamente se trattato con foscarnet.
    10.Essere in grado di ingerire compresse
    11.Essere disposto ed avere le cognizioni e le capacità per aderire integralmente alle procedure dello studio e alle limitazioni definite nel protocollo
    12.Essere in grado di fornire i campioni necessari (ad es. biopsie) per la diagnosi di malattia da CMV invasiva del tessuto al baseline stabilita dallo sperimentatore
    13.Aspettativa di vita di ≥8 settimane
    E.4Principal exclusion criteria
    1.Have a current CMV infection that is considered refractory or resistant
    due to inadequate adherence to prior anti-CMV treatment, to the best
    knowledge of the investigator
    2.Requires ganciclovir, valganciclovir, foscarnet, or cidofovir
    administration for conditions other than CMV when study treatment is
    initiated (example: herpes simplex virus (HSV) coinfection requiring use
    of any of these agents after the randomization) or would need a
    coadministration with maribavir for CMV infection
    (example: intraocular administration of ganciclovir for CMV retinitis).
    NOTE: A subject who is not continuing with the same anti-viral
    drug(s)(ganciclovir, valganciclovir, or foscarnet) for the study must
    discontinue their use before the first dose of study drug. If subject is
    currently being treated with cidofovir and is assigned another anti-CMV
    agent by the investigator, the subject must discontinue its use at least
    14 days prior to randomization at Visit 2/Day 0 and the first dose of
    study treatment.
    3.Be receiving leflunomide, or artesunate when study treatment is initiated. NOTE: Subjects who may be receiving leflunomide must
    discontinue the use at least 14 days prior to randomization at Visit
    2/Day 0 and the first dose of study treatment. Subjects receiving
    artesunate must discontinue the use prior to the first dose of
    study treatment.
    4.Have severe vomiting, diarrhea, or other severe gastrointestinal illness
    within 24 hours prior to the first dose of study treatment that would
    preclude administration of oral/enteral medication
    5.Have known hypersensitivity to the active substance or to an excipient
    for a study treatment
    6.Have tissue invasive CMV disease with central nervous system
    involvement
    7.Serum aspartate aminotransferase (AST) >5 times upper limit of
    normal (ULN) at screening, or serum alanine aminotransferase (ALT) >5
    times ULN at screening, or total bilirubin ≥3.0 x ULN at screening
    (except for documented Gilbert's syndrome), by local or central lab.
    NOTE: Subjects with biopsy confirmed CMV hepatitis will not be excluded
    from study participation despite AST or ALT >5 times ULN at screening.
    8.Have positive results for human immunodeficiency virus (HIV).
    Subjects must have a confirmed negative result within 3 months of study
    entry or be willing to be tested at screening. Local laboratory results are
    acceptable.
    9.Require mechanical ventilation or vasopressors for hemodynamic
    support at the time of enrollment
    10.Be female and pregnant or breast feeding
    11.Have previously received maribavir
    12.Have received any investigational agent with known anti-CMV activity
    within 30 days before initiation of study treatment or investigational
    anti-CMV vaccine at any time
    13.Have active malignancy with the exception of nonmelanoma skin
    cancer. Subjects who have had a HSCT and who experience relapse or
    progression of the malignancy, as per investigator's opinion are not to
    be enrolled.
    14.Undergoing treatment for acute or chronic hepatitis C
    15.Have any clinically significant medical or surgical condition that, in
    the investigator's opinion, could interfere with the interpretation of
    study results, contraindicate the administration of the assigned study
    treatment, or compromise the safety or well-being of the subject
    1.Presentare un'attuale infezione da CMV considerata refrattaria o resistente a causa di aderenza inadeguata a precedente trattamento anti-CMV, per quanto a conoscenza dello sperimentatore
    2.Richiedere la somministrazione di ganciclovir, valganciclovir, foscarnet, o cidofovir per condizioni diverse da CMV quando il trattamento in studio è iniziato (per esempio infezione concomitante da virus herpes simplex (HSV) che richieda l'uso di uno qualsiasi di questi agenti dopo la randomizzazione) o di somministrazione concomitante di maribavir per infezione da CMV (per esempio somministrazione intraoculare di ganciclovir per retinite da CMV). NOTA: Un soggetto che non prosegue il trattamento con lo stesso farmaco (o farmaci) antivirale/i (ganciclovir, valganciclovir, o foscarnet) per lo studio deve interromperne l'utilizzo prima della prima dose di farmaco in studio. Se un soggetto è attualmente in trattamento con cidofovir ed è assegnato a un altro agente anti-CMV dallo sperimentatore, deve interromperne l'uso almeno 14 giorni prima della randomizzazione alla Visita 2/Giorno 0 e prima della prima dose di trattamento in studio.
    3.Ricevere leflunomide o artesunato quando il trattamento in studio inizia. NOTA: I soggetti che possono ricevere leflunomide devono interromperne l'uso almeno 14 giorni prima della randomizzazione alla Visita 2/Giorno 0 e prima della prima dose di trattamento in studio. I soggetti che ricevono artesunato devono interromperne l'uso prima della prima dose di trattamento in studio.
    4.Presentare gravi episodi di vomito, diarrea o altra grave malattia gastrointestinale entro 24 ore prima della prima dose di trattamento in studio che precluderebbero la somministrazione di farmaci per via orale/enterica
    5.Presentare nota ipersensibilità al principio attivo o a un eccipiente di un trattamento in studio
    6.Presentare una malattia da CMV invasiva tissutale con coinvolgimento del sistema nervoso centrale
    7.Aspartato aminotransferasi nel siero (AST) >5 volte il limite superiore della norma (ULN) allo screening, o alanina aminotransferasi nel siero (ALT) >5 volte il ULN allo screening, o la bilirubina totale ≥3,0 x ULN allo screening (eccetto per sindrome di Gilbert documentata), secondo le analisi del laboratorio centrale o locale. NOTA: I soggetti con epatite da CMV confermata da biopsia non saranno esclusi dalla partecipazione allo studio nonostante AST o ALT >5 volte il ULN allo screening.
    8.Presentare risultati positivi al test per il virus dell'immunodeficienza umana (HIV). I soggetti devono presentare un risultato negativo confermato entro 3 mesi dall'ingresso nello studio o essere disposti a sottoporsi al test allo screening. Sono accettabili risultati del laboratorio locale.
    9.Avere bisogno di ventilazione meccanica o di vasopressori per supporto emodinamico al momento dell'arruolamento
    10. Essere una donna in stato di gravidanza o allattare al seno
    11. Aver ricevuto in precedenza trattamento con maribavir
    12. Aver ricevuto trattamento con qualsiasi agente sperimentale con nota attività anti-CMV entro 30 giorni prima dell'inizio del trattamento in studio o vaccino sperimentale anti-CMV in qualsiasi momento
    13. Presentare tumore maligno attivo con l'eccezione di carcinoma cutaneo non melanomatoso. I soggetti che si sono sottoposti a HSCT e che manifestano recidiva o progressione del tumore maligno, secondo il giudizio dello sperimentatore, non devono essere arruolati.
    14. Essere in trattamento per epatite C acuta o cronica
    15. Presentare una condizione clinicamente o chirurgicamente significativa tale che, secondo l'opinione dello sperimentatore, potrebbe interferire con l'interpretazione dei risultati dello studio, controindicare la somministrazione del trattamento in studio assegnato, o compromettere la sicurezza o il benessere dei soggetti

    E.5 End points
    E.5.1Primary end point(s)
    Confirmed CMV viremia clearance
    Clearance della viremia da CMV confermata

    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of 8 weeks of treatment
    Alla fine di 8 settimane di trattamento
    E.5.2Secondary end point(s)
    Achievement of CMV viremia clearance at the end of 8 weeks of treatment and esolution/improvement of tissue invasive CMV disease for subjects symptomatic at baseline or achievement of clearance of viremia and no symptoms of tissue invasive CMV disease for subjects
    asymptomatic at baseline at the end of 8 weeks of treatment, followed by maintenance of this treatment effect for an additional 8 weeks off treatment (ie, Follow-up Week 16)
    Raggiungimento della clearance della viremia da CMV al termine di 8 settimane di trattamento e risoluzione/miglioramento di malattia da CMV invasiva tissutale per soggetti sintomatici alla baseline o raggiungimento della clearance della viremia e assenza di sintomi della malattia da CMV invasiva tissutale per soggetti asintomatici alla baseline al termine di 8 settimane di trattamento, seguito da mantenimento di questo effetto di trattamento per altre 8 settimane dalla sospensione del trattamento (ossia, alla Settimana 16 di Follow-up)
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of 8 weeks of treatment
    alla fine delle 8 settimane di trattamento
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Australia
    Austria
    Belgium
    Canada
    Croatia
    Czech Republic
    France
    Germany
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Singapore
    Spain
    Sweden
    Switzerland
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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 Yes
    F.1.1Number of subjects for this age range: 1
    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.1.1.6.1Number of subjects for this age range: 17
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 281
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 53
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients > 12 years are eligible for participation. They are generally not able to give consent personally.
    Sono eleggibili per la partecipazione allo studio pazienti con età >12 anni. Questi pazienti non sono generalmente capaci di dare il proprio consenso personalmente
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 209
    F.4.2.2In the whole clinical trial 351
    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)
    Standard-Of-Care
    Standard-Of-Care
    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 Decision2017-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
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