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    Summary
    EudraCT Number:2016-003632-20
    Sponsor's Protocol Code Number:GS-US-320-4018
    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:2017-03-31
    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 number2016-003632-20
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching from Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25mg QD in Subjects with Chronic Hepatitis B who are Virologically Suppressed
    Estudio de fase III, aleatorizado, doble ciego, para evaluar la eficacia y seguridad del cambio de Tenofovir Disoproxil Fumarato (TDF) 300 mg una vez al día a Tenofovir Alafenamida (TAF) 25 mg una vez al día, en pacientes con hepatitis B crónica y supresión virológica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to understand the safety and effectiveness of switching from an existing drug called Viread to a new drug called TAF for the treatment of long term hepatitis B infection
    Estudio para conocer la seguridad y eficacia del cambio de un medicamento existente llamado Viread a un nuevo medicamento llamado TAF para el tratamiento de la infección de hepatitis B a largo plazo
    A.4.1Sponsor's protocol code numberGS-US-320-4018
    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 SponsorGilead Sciences, 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical trials mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34913789830
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.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 Yes
    D.2.1.1.1Trade name Vemlidy
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameVemlidy
    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 INNTENOFOVIR ALAFENAMIDE
    D.3.9.1CAS number 379270-37-8
    D.3.9.4EV Substance CodeSUB121761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 Viread
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameViread
    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 INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.4EV Substance CodeSUB12607MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Hepatitis B
    Hepatitis crónica B
    E.1.1.1Medical condition in easily understood language
    Long term infection with hepatitis B virus
    Infección a largo plazo con el virus de la hepatitis B
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10008910
    E.1.2Term Chronic hepatitis B
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are as follows:
    -To evaluate the efficacy of switching to TAF 25 mg QD versus continued TDF 300 mg QD in virologically suppressed subjects with chronic HBV as determined by the proportion of subjects with HBV DNA >= 20 IU/mL (as defined by the modified US FDA-defined snapshot algorithm) at Week 48
    -To compare the safety and tolerability of switching to TAF 25 mg QD versus continuing TDF 300 mg QD in virologically suppressed subjects with chronic HBV at Week 48
    Los objetivos principales de este estudio son los siguientes:
    • Evaluar la eficacia del cambio a TAF 25 mg una vez al día en comparación con la continuación del tratamiento con TDF 300 mg una vez al día en pacientes con infección crónica por el VHB y supresión virológica, determinada mediante la proporción de pacientes con ADN del VHB >=20 UI/ml (según la definición del algoritmo snapshot de la FDA estadounidense modificado), en la semana 48.
    • Evaluar la seguridad y tolerabilidad del cambio a TAF 25 mg una vez al día en comparación con la continuación del tratamiento con TDF 300 mg una vez al día en pacientes con infección crónica por el VHB y supresión virológica, en la semana 48.
    E.2.2Secondary objectives of the trial
    The key secondary objectives of this study are as follows:
    -To compare the safety of switching to TAF 25 mg QD versus continued TDF 300 mg QD as determined by the percent change from baseline in hip and spine Bone Mineral Density at Week 48
    -To compare the safety of switching to TAF 25 mg QD versus continued TDF 300 mg QD as determined by the change from baseline in estimated creatinine clearance by Cockcroft-Gault method at Week 48
    Los principales objetivos secundarios de este estudio son los siguientes:
    • Comparar la seguridad del cambio a TAF 25 mg una vez al día con la continuación del tratamiento con TDF 300 mg una vez al día, determinada mediante el cambio porcentual desde el inicio hasta la semana 48 en la densidad mineral ósea (DMO) de la cadera y la columna vertebral.
    • Comparar la seguridad del cambio a TAF 25 mg una vez al día con la continuación del tratamiento con TDF 300 mg una vez al día, determinada mediante el cambio desde el inicio en el aclaramiento de creatinina calculado mediante la fórmula de Cockcroft-Gault (TFGeCG), en la semana 48.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of
    study procedures
    2)Adult male and non-pregnant, non-lactating female subjects, >=18 years of age based on the date of the screening visit. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential
    3) Documented evidence of chronic HBV infection previously (e.g., documented HBsAg positive for more than 6 months)
    4) Maintained on TDF 300 mg QD for at least 48 weeks, and as monotherapy for CHB for at least 24 weeks prior to screening and with viral suppression (HBV DNA < LLOQ by local laboratory assessment) for a minimum of 12 weeks prior to Screening, and including a Screening HBV DNA value of < 20 IU/mL (by central laboratory). The assay that will be used to quantify HBV DNA in Study GS-US-320-4018 is the Roche COBAS Ampliprep-COBAS TaqMan Hepatitis B Test v2.0
    5) Estimated creatinine clearance >=50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the Screening evaluation
    6) Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant)
    7) Must be willing and able to comply with all study requirements
    1) Deben poder comprender y firmar un formulario de consentimiento informado por escrito, que debe obtenerse antes de iniciar los procedimientos del estudio
    2) Pacientes adultos, varones y mujeres no embarazadas ni en período de lactancia, de edad >=18 años en la fecha de la visita de selección. Se exige un resultado negativo en una prueba de embarazo en suero en la selección en el caso de las mujeres con capacidad de concebir.
    3) Pruebas documentadas de infección crónica por el VHB previamente (p. ej., resultado positivo en la detección de HBsAg documentado hace más de 6 meses).
    4) Tratamiento con TDF 300 mg una vez al día mantenido durante un mínimo de 48 semanas, y en monoterapia para la HBC durante un mínimo de 24 semanas antes de la selección, y con supresión virológica (ADN del VHB <LID según el análisis del laboratorio local) durante un mínimo de 12 semanas antes de la selección, e incluyendo un valor de ADN del VHB en la selección <20 UI/ml (según el análisis del laboratorio central). El análisis que se empleará para cuantificar el ADN del VHB en el estudio GS-US-320-4018 es el COBAS Ampliprep/COBAS TaqMan Hepatitis B Test v2.0 de Roche.
    5) Aclaramiento de creatinina estimado >=50 ml/min (método de Cockcroft-Gault) según la creatinina sérica y el peso corporal real determinados en la evaluación de selección.
    6) ECG normal (o, en caso de anomalías, el investigador determina que no son clínicamente significativas).
    7) Debe tener voluntad y capacidad de cumplir con todos los requisitos del estudio.
    E.4Principal exclusion criteria
    1) Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
    2) Males and females of reproductive potential who are unwilling to use an “effective”, protocol-specified method(s) of contraception during the study.
    3) Co-infection with HCV, HDV, HIV
    -Subjects who are HCV positive, but have a documented negative HCV RNA, are eligible
    4)Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging)
    5) Current evidence of, or recent (<= 5 year) history of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
    6) Abnormal hematological and biochemical parameters
    7) Received solid organ or bone marrow transplant
    8) Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator
    9) Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection
    (e.g. basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible.
    10) Currently receiving therapy with immunomodulators (e.g. corticosteroids), nephrotoxic agents, or agents capable of
    modifying renal excretion
    11) Known hypersensitivity to study drugs, metabolites, or formulation excipients
    12) Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
    13) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
    14) Use of investigational agents within 3 months of Screening, unless allowed by the Sponsor
    15) Use of any prohibited medications. Subjects on prohibited medications, who are otherwise eligible, will need a wash out period of at least 30 days prior to the Baseline visit.
    1) Mujeres embarazadas, en período de lactancia, o que crean que quizá deseen quedarse embarazadas durante el transcurso del estudio.
    2) Varones y mujeres con capacidad reproductiva que no deseen utilizar un método anticonceptivo “eficaz” especificado en el protocolo durante el estudio.
    3) Infección simultánea con el VHC, VHD o VIH.
    • Son aptos los pacientes con VHC pero con un resultado documentado de ARN del VHC negativo.
    4) Signos de carcinoma hepatocelular (p. ej., mediante una exploración por la imagen reciente).
    5) Signos en curso o antecedentes recientes (<=5 años) de descompensación hepática clínica (p. ej., ascitis, encefalopatía o hemorragia por varices).
    6) Parámetros bioquímicos y hematológicos anormales
    7) Recepción de un trasplante de víscera maciza o médula ósea.
    8) Enfermedad renal, cardiovascular, pulmonar o neurológica, que sea significativa en opinión del investigador.
    9) Neoplasia maligna en los 5 años previos a la selección, a excepción de algunos tipos específicos de cáncer que se curan mediante resección quirúrgica.
    10) Tratamiento en curso con inmunomoduladores (p. ej., corticoesteroides), o con agentes nefrotóxicos o capaces de modificar la excreción renal.
    11) Hipersensibilidad conocida a los fármacos del estudio, los metabolitos o los excipientes de la formulación.
    12) Abuso de sustancias o alcohol en curso que, en opinión del investigador, pueda interferir en el cumplimiento terapéutico del paciente.
    13) Cualquier otra situación clínica o tratamiento previo que, en opinión del investigador, haga que el paciente no sea apto para el estudio o que no pueda cumplir con los requisitos posológicos.
    14) Uso de fármacos en investigación en los 3 meses previos a la selección, a menos que lo permita el promotor.
    15) Uso de alguno de los medicamentos prohibidos. Los pacientes que estén recibiendo medicamentos prohibidos y que, por lo demás, sean aptos para participar, necesitarán un período de lavado de 30 días como mínimo antes de la visita inicial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is:
    -Proportion of subjects with HBV DNA >= 20 IU/mL (as determined by the modified US FDA-defined snapshot algorithm) at Week 48
    Proporción de pacientes con ADN del VHB >=20 UI/ml (según la definición del algoritmo snapshot de la FDA estadounidense modificado) en la semana 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Semana 48
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    -Proportion of subjects with HBV DNA >= 20 IU/mL (as determined by the modified US FDA-defined snapshot algorithm) at Week 96
    -Proportion of subjects with serological response (loss of Hepatitis B s antigen [HBsAg] and seroconversion to anti-HBs,
    and loss of Hepatitis B e antigen [HBeAg] and seroconversion to anti-HBe in HBeAg-positive subjects) at Weeks 48 and 96
    -Proportion of subjects with biochemical response (normal ALT and normalized ALT) at Weeks 48 and 96
    -Change from baseline in fibrosis as assessed by FibroTest® at Weeks 48 and 96
    -Proportion of subjects with HBV DNA < 20 IU/mL and target detected/not detected (i.e. < LLOD) at Weeks 48 and 96
    Los principales objetivos secundarios son:
    • Proporción de pacientes con ADN del VHB >=20 UI/ml (según la definición del algoritmo snapshot de la FDA estadounidense modificado) en la semana 96.
    • Proporción de pacientes con respuesta serológica (pérdida del antígeno s de la hepatitis B [HBsAg] y seroconversión a anti-HBs y pérdida del antígeno e de la hepatitis B [HBeAg] y seroconversión a anti-HBe en pacientes con HBeAg-positivo) en las semanas 48 y 96.
    • Proporción de pacientes con respuesta bioquímica (ALT normal y ALT normalizada) en las semanas 48 y 96.
    • Cambio en la fibrosis evaluada por FibroTest® desde el inicio hasta las semanas 48 y 96.
    • Proporción de pacientes con ADN del VHB <20 UI/ml y proporción detectado/no detectado objetivo (es decir, <LID) en las semanas 48 y 96.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48, Week 96
    Semana 48, semana 96
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Canada
    Hong Kong
    Italy
    Korea, Republic of
    Spain
    Taiwan
    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
    End of Study is defined as when the last subject has completed 96 weeks of treatment, or when the last subject has completed 96 weeks of treatment and up to 24 weeks of treatment free follow-up if appropriate, alternative anti-HBV treatment is not initiated after completing 96 weeks of study treatment.
    El Fin de estudio se define cuando el último paciente ha completado las 96 semanas de tratamiento, o cuando el último paciente ha completado las 96 semanas de tratamiento y hasta 24 semanas de seguimiento sin tratamiento si es apropiado, no se inicia el tratamiento alternativo anti-VHB hasta después de completar 96 semanas de tratamiento del estudio.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 276
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 184
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 460
    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)
    Once a subject has completed their study participation, the long-term care of the participant will return to the responsibility of their primary treating physicians.
    Una vez que un paciente ha completado su participación en el estudio, el cuidado a largo plazo del participante volverá a ser responsabilidad de su médico de atención primaria.
    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 Decision2017-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-30
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