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    Summary
    EudraCT Number:2015-004726-34
    Sponsor's Protocol Code Number:SHP620-302
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-004726-34
    A.3Full title of the trial
    A Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study to assess the efficacy and safety of maribavir compared to valganciclovir for the treatment of cytomegalovirus (CMV) infection in hematopoietic stem cell transplant recipients
    Studio di Fase 3, multicentrico, randomizzato, in doppio cieco, a doppio mascheramento (“double-dummy”), con controllo attivo, per valutare l'efficacia e la sicurezza di maribavir rispetto a valganciclovir per il trattamento delle infezioni da citomegalovirus (CMV) in soggetti sottoposti a trapianto di cellule staminali emopoietiche.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine how safe and effective maribavir versus valganciclovir is in treating cytomegalovirus in hematopoietic stem cell transplant patients.
    Studio per stabilire la sicurezza e l'efficacia di maribavir rispetto a valganciclovir nel trattamento di citomegalovirus in pazienti sottoposti a trapianto di cellule staminali emopoietiche
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberSHP620-302
    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 code02421
    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 code-
    D.3.9.3Other descriptive nameInibitore di serina/treonina chinasi
    D.3.9.4EV Substance CodeSUB03090MIG
    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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.9.4EV 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Recipients
    Infezione da citomegalovirus in riceventi di trapianto di cellule staminali emopoietiche
    E.1.1.1Medical condition in easily understood language
    Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant patients
    Infezione da citomegalovirus in pazienti sottoposti a trapianto di cellule staminali empoietiche
    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 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 valganciclovir in CMV viremia clearance at the end of Study week 8 in asymptomatic CMV infection in hematopoietic stem cell translplant (HSCT) recipients.
    Mettere a confronto l'efficacia di maribavir e valganciclovir nella clearance della viremia da CMV alla fine della settimana 8 dello studio nell'infezione da CMV asintomatica in soggetti che hanno ricevuto trapianto di cellule staminali emopioetiche (HSCT)
    E.2.2Secondary objectives of the trial
    The key secondary objective of this study is to compare the efficacy of maribavir and valganciclovir on maintenance of CMV viremia clearance, achieved at the end of Study Week 8 through Study Week 16 (8 weeks of post-treatment/follow-up Phase).
    L'obiettivo secondari principale di questo studio è mettere a confronto l'efficacia di maribavir e valganciclovir nel mantenimento della clearance della viremia CMV, ottenuta al termine della settimana 8 dello studio fino alla settimana 16 dello studio (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 before completing 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 ≥16 years of age at the time of consent.
    3.Be a recipient of hematopoietic stem cell transplant.
    4.Have a documented asymptomatic CMV infection, with a screening value of CMV DNA ≥2730 IU/mL to ≤273000 IU/mL in whole blood or ≥
    910 IU/mL to ≤ 91000 IU/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. Asymptomatic CMV infection is defined as an infection that does not present with tissue invasive CMV disease, as assessed by the investigator.
    5.Have the current CMV infection as the first episode of CMV viremia after HSCT, either primary or reactivation.
    6.Per investigator's judgment, be eligible for treatment with valganciclovir.
    7.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 ≥1000/mm3 [1.0 x 109/L] b.Platelet count ≥25,000/mm3 [25 x 109/L] c.Hemoglobin ≥8g/dL.
    d.Estimated creatinine clearance ≥60mL/min/1.73m2
    8.Have a negative serum beta human chorionic gonadotropin (β-HCG)
    pregnancy test at screening, if a
    female of child bearing potential. Urine pregnancy tests may be done per institutional requirements;
    however they are not sufficient for eligibility determination. 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 the last dose of study treatment.
    9.Be able to swallow tablets.
    10.Have life expectancy of ≥ 8 weeks.
    11.Have weight ≥40 kg.
    12.Be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
    1. Essere in grado di fornire il consenso informato scritto alla partecipazione allo studio, firmato e datato personalmente prima del completamento di qualsiasi procedura correlata allo studio. Se pertinente, uno o entrambi i genitori o il rappresentante legale autorizzato (LAR) devono fornire la firma del consenso informato e deve esserci documentazione dell'assenso del soggetto prima del completamento di qualsiasi procedura correlata allo studio.
    2. Avere ≥ 16 anni al momento del consenso.
    3. Avere ricevuto trapianto di cellule staminali emopoietiche.
    4. Presentare un'infezione da CMV asintomatica documentata, con valore allo screening al test per il DNA del CMV da ≥2730 IU/ml a ≤273000 IU/ml nel sangue intero o da ≥910 IU/ml a ≤91000 IU/ml nel plasma in 2 valutazioni consecutive distanziate di almeno 1 giorno, come stabilito dalla reazione a catena della polimerasi quantitativa (qPCR) condotta dal laboratorio specialistico centrale o locale o dai risultati di analisi quantitative del DNA del CMV equivalenti. Entrambi i campioni devono essere prelevati entro i 14 giorni precedenti la
    randomizzazione, il secondo dei quali entro i 5 giorni precedenti la randomizzazione. Queste valutazioni devono essere fatte dallo stesso laboratorio e sullo stesso tipo di campione (sangue intero o plasma). Un'infezione da CMV asintomatica è definita come infezione che in base alla valutazione dello sperimentatore non presenta malattia invasiva tissutale da CMV.
    5. Avere infezione da CMV in corso come primo episodio di viremia CMV post HSCT, verificantesi come infezione primaria o come riattivazione di pregressa infezione.
    6.Essere eleggibili, a giudizio dello sperimentatore, a trattamento con valganciclovir.
    7. Presentare tutti i seguenti risultati nell'ambito delle valutazioni di laboratorio di screening (per la qualificazione possono essere usati i risultati del laboratorio centrale o di un laboratorio locale):
    a.Conta assoluta dei neutrofili ≥1000/mm3 [1,0 x 109/l]
    b.Conta piastrinica ≥25.000/mm3 [25 x 109/l]
    c.Emoglobina ≥8g/dl.
    d.Clearance della creatinina stimata ≥60ml/min/1,73m2
    8. Avere un test di gravidanza β-hCG (gonadotropina corionica umana) su siero negativo allo screening, se
    donne in età fertile. Test di gravidanza su urine possono essere eseguiti in conformità ai requisiti istituzionali;
    tuttavia non sono sufficienti per stabilire l'eleggibilità. 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 dopo l’ultima dose di farmaco in studio.
    9. Essere in grado di ingerire compresse.
    10. Avere un'aspettativa di vita ≥8 settimane.
    11. Avere un peso corporeo ≥40 kg.
    12. Essere disposto a ed avere le cognizioni e le capacità per aderire integralmente alle procedure dello studio e alle limitazioni definite nel protocollo.
    E.4Principal exclusion criteria
    1. Have CMV tissue invasive disease as assessed by the investigator at the time of screening and randomization at Visit 2/Day 0.
    2. Have a CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir based on documented evidence.
    3. Be presenting with recurrent CMV infection (defined as a new detection of CMV infection requiring treatment in a subject who had at least one previously documented episode of CMV infection post- transplant, and who has had at least 2 weeks of undetectable CMV DNA between the episodes (during active surveillance, based on same local laboratory and same sample type). The subject must also have been off any anti-CMV treatment between the current and prior infection. Otherwise, the current infection may be considered continuation of the prior infection.
    4. Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus [HSV] co-infection requiring use of any of these agents after the randomization) or would need a co- administration with maribavir for CMV infection.
    5. 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.
    6. Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or cidofovir) for the current CMV infection for longer than 72 hours.
    Note: A subject who is receiving these anti-CMV agents must discontinue their use before the first dose of study treatment. A subjects who may be receiving cidofovir must discontinue this antiviral at least 14 days prior
    to randomization at Visit 2/Day 0 and the first dose of study treatment. Note: Subjects who were administered these anti-CMV agents for prophylaxis should have these treatments completed at least 2 weeks prior to the study entry or start of the treatment for current infection, whichever comes first, and have undetectable CMV DNA (based on local laboratory) for at
    least 2 weeks between the completion of the anti-CMV prophylaxis and onset of the current infection.
    7. Have known hypersensitivity to the active substance or to an excipient of the study treatments.
    8. 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 medication.
    9. Require mechanical ventilation or vasopressors for hemodynamic support at the time of randomization.
    10. Be female and pregnant or nursing.
    11. Have previously completed, discontinued, or have been withdrawn from this study.
    12. Have received any investigational agent with known anti-CMV
    activity within 30 days before initiation of study treatment or CMV vaccine at any time.
    13. Have received any unapproved agent or device within 30 days before initiation of study treatment.
    14. Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the subject.
    15. Have previously received maribavir.
    16. Have 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), as analyzed by local or central lab.
    17. Have known (previously documented) positive results for human immunodeficiency virus (HIV).
    18. Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Subjects who experience relapse or progression of their underlying malignancy (for which HSCT was performed), as determined by the investigator, are not to be enrolled.
    19. Be undergoing treatment for acute or chronic hepatitis C.
    1. Presentare malattia invasiva tissutale da CMV, valutata dallo sperimentatore all'epoca dello screening e della randomizzazione alla Visita 2/Giorno 0.
    2. Presentare un'infezione da CMV nota per la resistenza genotipica a ganciclovir, valganciclovir, foscarnet, o cidofovir in base a prove documentate.
    3. Presentare infezione da CMV ricorrente, (definita come nuova rilevazione di infezione da CMV necessitante di trattamento in un soggetto che aveva avuto almeno un episodio precedentemente documentato di infezione da CMV post trapianto e almeno 2 settimane di DNA del CMV non rilevabile tra gli episodi (durante la sorveglianza attiva, in base ai risultati ottenuti dallo stesso laboratorio locale e dallo stesso tipo di campione). Il soggetto deve anche aver interrotto il trattamento anti-CMV tra l'attuale e la precedente infezione. Altrimenti, l'infezione in corso può essere considerata una continuazione della precedente infezione.
    4. Richiedere la somministrazione di ganciclovir, valganciclovir, foscarnet, o cidofovir per condizioni diverse da CMV all'epoca in cui è iniziato il trattamento in studio (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.
    5. Ricevere leflunomide o artesunato all'inizio del trattamento in studio. 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 del trattamento in studio. I soggetti che ricevono artesunato devono interromperne l'uso prima della prima dose del trattamento in studio.
    6. Essere in trattamento con agenti anti-CMV (ganciclovir, valganciclovir, foscarnet o cidofovir) per l'infezione da CMV in corso da oltre 72 ore.
    Nota: Un soggetto in trattamento con questi agenti anti-CMV deve interromperne l'assunzione prima di assumere la prima dose del trattamento in studio. I soggetti che possono ricevere cidofovir devono interrompere l'uso di questo antivirale almeno 14 giorni prima della randomizzazione alla Visita 2/Giorno 0 e prima della prima dose del trattamento in studio.
    Nota: I soggetti che hanno ricevuto questi agenti anti-CMV a scopo di profilassi devono aver completato questi trattamenti da almeno 2 settimane prima dell'ingresso nello studio o dell'inizio del trattamento per l'infezione in corso, a seconda di quale di questi eventi si verifichi per primo, e DNA del CMV non rilevabile (in base ai risultati del laboratorio locale) per almeno 2 settimane tra la conclusione della profilassi anti-CMV e l'insorgenza dell'infezione in corso.
    7. Presentare ipersensibilità nota al principio attivo o a uno degli eccipienti dei trattamenti in studio.
    8. Manifestare entro le 24 ore precedenti alla prima dose del trattamento in studio episodi gravi di vomito, diarrea o altra grave malattia gastrointestinale, che precluderebbero la somministrazione di farmaci per via orale.
    9. Avere bisogno di ventilazione meccanica o di farmaci vasopressori per fornire un supporto emodinamico al momento della randomizzazione.
    10. Essere una donna in gravidanza o che allatta al seno.
    11. Avere precedentemente completato, interrotto o essere stato/a ritirato/a da questo studio.
    12. Avere ricevuto un agente sperimentale con attività anti-CMV nota, entro i 30 giorni precedenti l'inizio del trattamento in studio o del vaccino anti-CMV in qualsiasi momento.
    13. Avere ricevuto un agente o un dispositivo non approvato entro i 30 giorni precedenti l'inizio del trattamento in studio.
    14. Presentare una condizione medica o chirurgica clinicamente significativa tale da, secondo l'opinione dello sperimentatore, interferire con l'interpretazione dei risultati dello studio, controindicare la somministrazione del trattamento in studio assegnato o compromettere la sicurezza o il benessere del soggetto.
    15. Avere ricevuto un precedente trattamento con maribavir.
    16. Aspartato aminotransferasi nel siero (AST) >5 volte il limite superiore della norma (ULN) allo screening, o alanina aminotransferasi nel siero (ALT) >5 volte l'ULN allo screening o bilirubina totale ≥3,0 volte l'ULN allo screening (eccetto per la sindrome di Gilbert documentata), secondo le analisi del laboratorio centrale o locale.
    17. Presentare risultati positivi noti (precedentemente documentati) al test per il virus dell'immunodeficienza umana (HIV).
    18. Avere un tumore maligno attivo ad eccezione del carcinoma cutaneo non melanomatoso, come stabilito dallo sperimentatore. I soggetti con recidiva o progressione della neoplasia maligna preesistente (per la quale è stato eseguito HSCT), in base a quanto stabilito dallo sperimentatore, non devono essere arruolati.
    19. Essere in trattamento per epatite C acuta o cronica.
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed clearance of plasma CMV DNA (CMV viremia clearance)
    Clearance confermata del DNA del CMV nel plasma (clearance della viremia CMV)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of 8 weeks of treatment
    Alla conclusione di 8 settimane di trattamento
    E.5.2Secondary end point(s)
    At the end of 8 weeks of treatment
    Mantenimento della clearance della viremia CMV
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the end of 8 weeks of treatment through Study Week 16
    Dopo la conclusione di 8 settimane di trattamento fino alla settimana 16 dello studio
    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 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.8.2.4Number 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Belgium
    Canada
    Croatia
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    New Zealand
    Poland
    Singapore
    Spain
    Switzerland
    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 years2
    E.8.9.1In the Member State concerned months7
    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 months7
    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: 110
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 358
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 82
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 285
    F.4.2.2In the whole clinical trial 550
    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
    Terapia standard (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 Decision2017-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-13
    P. End of Trial
    P.End of Trial StatusOngoing
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