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    Summary
    EudraCT Number:2017-002423-19
    Sponsor's Protocol Code Number:BGB-A317-301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-21
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-002423-19
    A.3Full title of the trial
    A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 versus Sorafenib as First-Line Treatment in Patients with Unresectable Hepatocellular Carcinoma
    Estudio de Fase 3, aleatorizado, abierto y multicéntrico, comparativo de la eficacia y la seguridad de BGB A317 frente a sorafenib como tratamiento de primera línea en pacientes con carcinoma hepatocelular no resecable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study of BGB-A317 Versus Sorafenib in Patients with Unresectable HCC
    Estudio de Fase 3 de BGB A317 frente a sorafenib en pacientes con carcinoma hepatocelular no resecable
    A.4.1Sponsor's protocol code numberBGB-A317-301
    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 SponsorBeiGene, Ltd. c/o BeiGene USA, 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 supportBeiGene, Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene, Inc.
    B.5.2Functional name of contact pointBeiGene Clinical Support
    B.5.3 Address:
    B.5.3.1Street AddressUSA
    B.5.3.2Town/ cityUSA
    B.5.3.3Post codeUSA
    B.5.3.4CountryUnited States
    B.5.6E-mailBeigeneClinicalSupportUS@beigene.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBGB-A317
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBGB-A317
    D.3.9.1CAS number 1858168-59-8
    D.3.9.2Current sponsor codeBGB-A317
    D.3.9.3Other descriptive nameBGB-A317
    D.3.9.4EV Substance CodeSUB189550
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Nexavar 200 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 nameNexavar
    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 INNSORAFENIB TOSYLATE
    D.3.9.1CAS number 475207-59-1
    D.3.9.4EV Substance CodeSUB22347
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unresectable Hepatocellular Carcinoma
    Carcinoma hepatocelular no resecable
    E.1.1.1Medical condition in easily understood language
    Unresectable Hepatocellular Carcinoma is a specific type of Liver cancer that is unable to be removed by surgery.
    El carcinoma hepatocelular no resecable es un tipo específico de cancer de hígado que no se puede eliminar mediante cirugía
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    E.1.2System Organ Class 100000004864
    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 OS between BGB-A317 and sorafenib as first-line treatment in patients with unresectable HCC
    Comparar la supervivencia global (overall survival, OS) entre BGB-A317 y sorafenib como tratamiento de primera línea en pacientes con carcinoma hepatocelular (hepatocellular carcinoma, HCC) no resecable
    E.2.2Secondary objectives of the trial
    •To compare ORR assessed by Blinded Independent Review Committee (BIRC) according to Response Evaluation Criteria in Solid Tumors [RECIST]) Version (v)1.1 between BGB-A317 and sorafenib
    • To compare progression-free survival (PFS) assessed by BIRC according to RECIST v1.1 between BGB-A317 and sorafenib
    • To compare DOR assessed by BIRC according to RECIST v1.1 between BGB-A317 and sorafenib
    • To compare time to progression (TTP) between BGB-A317 and sorafenib
    • To compare health-related quality of life (HRQoL) between BGB-A317 and sorafenib
    • To compare tumor assessment outcomes (ie, ORR, PFS, DOR, TTP) assessed by Investigator according to RECIST v1.1 between BGB-A317 and sorafenib
    • To compare disease control rate (DCR) and clinical benefit rate (CBR), assessed by BIRC and Investigator according to RECIST v1.1, between BGB-A317 and sorafenib
    • To compare safety and tolerability of BGB-A317 versus sorafenib
    •Comparar la tasa de respuesta objetiva,evaluada por un Comité de Revisión independiente desconocedor del tratamiento según los Criterios
    de Evaluación de la Respuesta en Tumores Sólidos Versión(v)1.1,entre BGB-A317 y sorafenib
    •Comparar la supervivencia sin progresión,evaluada por el BIRC según los RECIST v1.1,entre BGB-A317 y sorafenib
    •Comparar la duración de la respuesta,evaluada por el BIRC según los RECIST v1.1,entre BGB-A317 y sorafenib
    •Comparar el tiempo hasta la progresión entre BGB-A317 y sorafenib
    •Comparar la calidad de vida relacionada con la salud entre BGB-A317 y sorafenib
    •Comparar los resultados de las evaluaciones del tumor (ORR,PFS,DOR,TTP) realizadas por el Investigador,según los RECISTv1.1,entre BGB-A317 y sorafenib
    • Comparar la tasa de control de la enfermedad y la tasa de beneficio clínico,evaluadas por el BIRC y por el Investigador,según los RECISTv1.1,entre BGB-A317 y sorafenib
    • Comparar la seguridad y tolerabilidad de BGB-A317 frente a sorafenib
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: SAFETY RUN-IN SUBSTUDY INVESTIGATING SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY ANTITUMOR ACTIVITY OF ANTI-PD-1 MONOCLONAL ANTIBODY BGB-A317 IN JAPANESE PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA
    Protocol Identifier: BGB-A317-301 Substudy
    Primary Study Objectives:
    • To assess the safety and tolerability of BGB-A317 in Japanese patients with hepatocellular carcinoma (HCC)
    • To confirm the pivotal Phase 3 dose of BGB-A317 in Japanese patients
    • To characterize the pharmacokinetics of BGB-A317 in Japanese patients
    Secondary Study Objectives:
    • To assess the preliminary antitumor activity of BGB-A317
    • To assess host immunogenicity to BGB-A317
    Título: SUBESTUDIO PREINCLUSIÓN DE SEGURIDAD, ACERCA DE LA SEGURIDAD, TOLERABILIDAD Y FARMACOCINÉTICA, Y DE VALORACIÓN PRELIMINAR DE LA ACTIVIDAD ANTITUMORAL, DE BGB-A317, UN ANTICUERPO MONOCLONAL ANTI-PD-1, EN PACIENTES JAPONESES CON CARCINOMA HEPATOCELULAR NO RESECABLE
    Identificador del protocolo: Subestudio de BGB-A317-301
    Objetivos principales del subestudio:
    • Evaluar la seguridad y la tolerabilidad de BGB-A317 en pacientes japoneses con carcinoma hepatocelular (hepatocellular carcinoma, HCC)
    • Confirmar la dosis de BGB-A317 para los estudios pivotales de Fase 3 en pacientes japoneses
    • Caracterizar la farmacocinética de BGB-A317 en pacientes japoneses
    Objetivos secundarios del subestudio:
    • Evaluar de forma preliminar la actividad antitumoral de BGB-A317
    • Evaluar la inmunogenia del huésped frente a BGB-A317
    E.3Principal inclusion criteria
    1. Histologically confirmed diagnosis of HCC
    2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach
    3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])
    4. Measurable disease
    5. Child-Pugh score A
    6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
    7. Adequate organ function
    1. Diagnóstico de HCC confirmado histológicamente
    2. Enfermedad en Estadio B o C según la clasificación Barcelona Clinic Liver Cancer (BCLC), no susceptible de o que ha progresado tras la administración de tratamiento loco-regional y no tributaria de una estrategia terapéutica curativa
    3. Ausencia de tratamiento sistémico previo por HCC (con la excepción de los pacientes con HCC incluidos en el subestudio preinclusión de la seguridad [sólo en Japón])
    4. Enfermedad medible
    5. Puntuación A de Child-Pugh
    6. Estado funcional del Easter Cooperative Oncology Group (ECOG) ≤ 1
    7. Función orgánica adecuada
    E.4Principal exclusion criteria
    1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
    2. Tumor thrombus involving main trunk of portal vein or inferior vena cava
    3. Loco-regional therapy to the liver within 28 days before randomization
    4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization
    5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment
    6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
    7. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization
    8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy
    9. QT interval corrected for heart rate (QTc) (corrected by Fridericia’s method) > 450 msec at Screening
    1. Histología conocida de HCC fibrolamelar, HCC sarcomatoide o mixta de colangiocarcinoma y HCC
    2. Trombo tumoral que afecta al tronco principal de vena porta o vena cava inferior
    3. Tratamiento loco-regional en hígado en el plazo de los 28 días anteriores a la aleatorización
    4. Signos clínicos de hipertensión portal con varices esofágicas o gástricas sangrantes en el screening (selección) o en el plazo de los 6 meses anteriores a la aleatorización
    5. Trastorno hemorrágico o trombótico o tratamiento anticoagulante que precisa control del international normalized ratio (esto es, warfarina o agentes similares) en el Screening o en el plazo de los 6 meses anteriores a la aleatorización/reclutamiento en el estudio
    6. Presencia en el Screening de deficiencia inmunitaria o enfermedad autoinmunitaria activas y/o antecedentes de cualquier deficiencia inmunitaria o enfermedad autoinmunitaria que puedan recidivar
    7. Cualquier proceso que haya precisado tratamiento sistémico con corticosteroides (> 10 mg al día de prednisona o equivalente) o con otro inmunosupresor en el plazo de los 14 días anteriores a la aleatorización
    8. Historia de neumopatía intersticial o de neumonitis no infecciosa, salvo en caso de inducción por radioterapia
    9. Intervalo QT corregido según la frecuencia cardíaca (QTc) (corrección de Fridericia) > 450 mseg en el Screening
    E.5 End points
    E.5.1Primary end point(s)
    • Overall Survival (OS) – defined as the time from the date of randomization to the date of death due to any cause
    • Supervivencia global (OS) – definida como el tiempo desde la fecha de aleatorización hasta la fecha de muerte debida a cualquier causa
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS assessed by Blinded Independent Review Committee (BIRC)
    Supervivencia global evaluada por un Comité de Revisión independiente desconocedor del tratamiento
    E.5.2Secondary end point(s)
    • Overall Response Rate (ORR) as assessed by BIRC – defined as the proportion of patients with a documented CR or PR per RECIST v1.1
    • Progression-free survival (PFS)– defined as the time from the date of randomization to the date of the first objectively documented tumor progression, assessed by BIRC per RECIST v1.1, or death, whichever occurs first
    • Duration of response (DOR) – defined as the time from the first determination of an objective response, assessed by BIRC per RECIST v1.1, until the first documentation of progression or death, whichever occurs first
    • Time to progression (TTP) – defined as the time from the date of randomization to the date of the first objectively documented tumor progression, assessed by BIRC per RECIST v1.1
    • Health-related quality of life (HRQoL)
    • Tumor assessment (ie, ORR, PFS, DOR and TTP), assessed by Investigator per RECIST v1.1
    • Disease control rate (DCR) – defined as the proportion of patients whose best overall response (BOR) is CR, PR, or SD, assessed by BIRC and Investigator per RECIST v1.1
    • Clinical benefit rate (CBR) – defined as the proportion of patients who have CR, PR, or SD of ≥ 24 weeks in duration, assessed by BIRC and Investigator per RECIST v1.1
    • Safety assessment
    • Tasa de respuesta objetiva (Overall Response Rate, ORR) evaluada por el BIRC – definida como el porcentaje de pacientes con CR o PR documentadas según RECIST v1.1
    • Supervivencia sin progresión (Progression-free survival, PFS) – definida como el periodo de tiempo transcurrido desde la fecha de la aleatorización a la fecha de la primera documentación objetiva de progresión del tumor, evaluada por el BIRC según RECIST v1.1, o a la muerte, dependiendo de la primera de estas circunstancias que tenga lugar
    • Duración de la respuesta (Duration of response, DOR) – definida como el periodo de tiempo transcurrido desde la primera determinación de una respuesta objetiva, evaluada por el BIRC según RECIST v1.1, hasta la primera documentación de progresión de la enfermedad o la muerte, dependiendo de la primera de estas circunstancias que tenga lugar
    • Tiempo hasta la progresión (Time to progression, TTP) – definido como el tiempo transcurrido desde la fecha de la aleatorización a la fecha de la primera documentación objetiva de progresión del tumor, evaluada por el BIRC según RECIST v1.1
    • Calidad de vida relacionada con la salud (Health-related quality of life, HRQoL)
    • Evaluación del tumor (esto es, ORR, PFS, DOR y TTP), por el Investigador según RECIST v1.1
    • Tasa de control de la enfermedad (Disease control rate, DCR) – definida como el porcentaje de pacientes cuya mejor respuesta global (best overall response, BOR) es CR, PR o SD, evaluada por el BIRC y el Investigador según RECIST v1.1
    • Tasa de beneficio clínico (Clinical benefit rate, CBR) – definida como el porcentaje de pacientes con CR, PR o SD de duración ≥ 24 semanas, evaluada por el BIRC y el Investigador según RECIST v1.1
    • Evaluaciones de la seguridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    • ORR by BIRC
    • PFS by BIRC
    • DOR by BIRC
    • TTP by BIRC
    • HRQoL
    • Tumor assessments (ORR, PFS, DOR, and TTP) assessed by Investigator per RECIST v1.1
    • DCR by BIRC and Investigator
    • CBR by BIRC and Investigator
    • Safety assessment (eg, new adverse events [AEs], AEs present at baseline that worsen in severity during the study, and clinical laboratory abnormalities)
    • ORR según el BIRC
    • PFS según el BIRC
    • DOR según el BIRC
    • TTP según el BIRC
    • HRQoL
    • Evaluaciones del tumor (ORR, PFS, DOR y TTP) por el Investigador según los RECIST v1.1
    • DCR por el BIRC y por el Investigador
    • CBR por el BIRC y por el Investigador
    • Evaluaciones de la seguridad (a saber, nuevos acontecimientos adversos [adverse events, AEs], AEs presentes en el punto basal cuya severidad empeore durante el estudio y anomalías de las determinaciones de laboratorio)
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    China
    European Union
    Japan
    Taiwan
    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
    última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 384
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 256
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 640
    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)
    There are no plans to provide study treatment after End of the study. Patients may be transferred to commercially available drug if available or other therapy as per investigator's medical judgment.
    No hay planes de suministrar tratamiento del estudio después del Fin del studio. Los pacientes pueden ser transferidos a una medicación disponible comercialmente si está disponible o a otra terapia de acuerdo al juicio médico del investigador
    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 Decision2018-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-22
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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