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    Summary
    EudraCT Number:2016-004566-26
    Sponsor's Protocol Code Number:3152-301-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    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 number2016-004566-26
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis
    Estudio de fase III, multicéntrico, aleatorizado, con doble enmascaramiento, controlado con placebo, para evaluar la eficacia y seguridad de cenicriviroc para el tratamiento de la fibrosis hepática en pacientes adultos con esteatohepatitis no alcohólica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study of an investigational drug, Cenicriviroc, for the treatment of liver fibrosis in patients with Nonalcoholic Steatohepatitis (NASH).
    Estudio de un medicamento en investigación, Cenicriviroc, para el tratamiento de la fibrosis hepática en pacientes con Esteatohepatitis no alcohólica (EHNA)
    A.3.2Name or abbreviated title of the trial where available
    STELLARIS
    A.4.1Sponsor's protocol code number3152-301-002
    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 SponsorTobira Therapeutics, a subsidiary of Allergan plc
    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 supportTobira Therapeutics, Inc, a subsidiary of Allergan, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTobira Therapeutics, a subsidiary of Allergan plc
    B.5.2Functional name of contact pointKarl Trass (Regulatory Affairs)
    B.5.3 Address:
    B.5.3.1Street Address701 Gateway Blvd, Suite 300
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34913913443
    B.5.5Fax number+1650741 6629
    B.5.6E-mailKarl.Trass@allergan.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 nameCenicriviroc Mesylate
    D.3.2Product code CVC
    D.3.4Pharmaceutical form 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 INNCENICRIVIROC MESYLATE
    D.3.9.1CAS number 497223-25-3
    D.3.9.2Current sponsor codeCENICRIVIROC
    D.3.9.3Other descriptive nameTBR-652
    D.3.9.4EV Substance CodeSUB180705
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboTablet
    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
    Liver fibrosis in Subjects with Nonalcoholic Steatohepatitis
    Fibrosis hepática en pacientes con esteatohepatitis no alcohólica
    E.1.1.1Medical condition in easily understood language
    Fatty Liver where the cells in the liver have abnormal fat built-up and built-up of scar tissue in the liver.
    Hígado graso donde las células del higado tienen una acumulación anormal de grasa y acumulación de tejido cicatrizal
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10053219
    E.1.2Term Non-alcoholic steatohepatitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective (Part 1):
    •Demonstrate the superiority of CVC compared to placebo on liver histology at Month 12 relative to the Screening biopsy, by assessing the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade)
    Primary Objective (Part 2):
    •Demonstrate the superiority of CVC compared to placebo on the composite endpoint of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality, as measured by the time to first occurrence of any of the listed adjudicated events (clinical outcomes composite endpoint) – (all subjects)
    Objetivo principal (parte 1):
    • Demostrar la superioridad de cenicriviroc (CVC) comparado con placebo en la histología hepática en el mes 12 con respecto a la biopsia de la selección, evaluando el siguiente criterio principal de valoración compuesto:
    Objetivo principal (parte 2):
    • Demostrar la superioridad de CVC comparado con placebo en el criterio de valoración compuesto de la progresión histopatológica a cirrosis, resultados clínicos hepáticos y mortalidad por cualquier causa, según el tiempo transcurrido hasta la primera manifestación de cualquiera de los acontecimientos adjudicados que se indican (criterio de valoración compuesto de resultados clínicos) – (todos los pacientes)
    E.2.2Secondary objectives of the trial
    Part 1 and 2: (1)Evaluate the effect of CVC compared to placebo on liver histology relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on steatohepatitis (months 12 and 60, as applicable).
    Part 1 and 2: (2)Evaluate the safety and tolerability of CVC for the treatment of liver fibrosis in adult subjects with NASH.
    Part 2: (3)Evaluate the effect of CVC compared to placebo on liver histology relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade), (months 12 and 60, as applicable)).
    Parte 1 y 2: (1)Evaluar el efecto de CVC comparado con placebo en la histología hepática con respecto a la biopsia de la selección para la proporción de pacientes con mejoría de la fibrosis al menos en 1 etapa (sistema de RIC EHNA) Y independientemente del efecto en la esteatohepatitis (meses 12 y 60, según corresponda).
    Parte 1 y 2: (2)Evaluar el perfil de seguridad terapéutica y tolerabilidad de CVC para el tratamiento de la fibrosis hepática en pacientes adultos con EHNA.
    Parte 2: (3)Evaluar el efecto de CVC comparado con placebo en la histología hepática con respecto a la biopsia de la selección para la proporción de pacientes con mejoría de la fibrosis al menos en 1 etapa (sistema de RIC EHNA)Y ausencia de agravamiento de la esteatohepatitis (ausencia de agravamiento del grado de inflamación lobular o degeneración balonizante de los hepatocitos), (meses 12 y 60, según corresponda).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Pharmacogenetic testing
    The goal of this research is to find variations in DNA that will help identify persons with Liver Fibrosis with Nonalcoholic Steatohepatitis that will have the best response with CVC or to identify persons who will have fewer side effects in order to maximize their benefit from CVC.
    Pruebas Farmacogeneticas opcionales.
    El objetivo dde esta investigación es encontrar variaciones en el ADN que puedan ayudar a identificar con Fibrosis hepática en pacientes con esteatohepatitis no alcohólica que puedan tener la mejor respuesta con CVC o identificat personas que tendrán menos efectos secundarios co el fin de maximizar los beneficios de CVC
    E.3Principal inclusion criteria
    1. Male and female subjects aged between 18-75 years
    2. Ability to understand and sign a written informed consent form (ICF)
    3. Histological evidence of NASH based on central reading of the biopsy slides
    4. Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN System based on central reading of the biopsy slides
    5. Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug.
    1. Pacientes masculinos y femeninos de entre 18 y 75 años de edad
    2. Capacidad para entender y firmar un consentimiento informado por escrito (CI)
    3. Evidencia histológica de fibrosis hepática de etapa 2 o 3 según el sistema RIC EHNA basada en el estudio centralizado de las muestras de biopsia del inicio (véase el criterio 3a acerca del uso de una biopsia anterior en sustitución de la biopsia del inicio)
    4. Las mujeres con posibilidad de quedar embarazadas y los hombres que participen en el estudio deben estar de acuerdo en utilizar al menos 2 métodos anticonceptivos aprobados a lo largo de la duración del estudio y durante los 30 días siguientes a la interrupción del fármaco del estudio. Las mujeres postmenopáusicas deben tener documentado el cese de la menstruación durante ≥ 12 meses y unos niveles de hormona foliculoestimulante (FSH) en suero ≥ 30 mUI/ml en la selección.
    E.4Principal exclusion criteria
    1. Inability to undergo a liver biopsy
    2. Hepatitis B surface antigen (HBsAg) positive
    3. Hepatitis C antibody (HCVAb) positive
    4. Human immunodeficiency virus (HIV)-1 or HIV-2 infection
    5. Prior or planned liver transplantation
    6. Other known causes of chronic liver disease
    7. History or presence of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
    8. Alcohol consumption greater than 21 units/week for males or 14 units/week for females
    9. AST > 200 IU/L in males and females at Screening
    10. ALT > 250 IU/L in males and > 200 IU/L in females at Screening
    11. HbA1c > 10% at Screening
    12. Serum albumin < 3.5 g/dL
    13. Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation
    14. Platelet count < 100,000/mm3
    15. Total bilirubin > 1.5 mg/dL (subjects with hyperbilirubinemia associated with documented Gilbert’s syndrome may be eligible upon review by the medical monitor)
    16. International normalized ratio (INR) > 1.3
    17. Model of end stage liver disease (MELD) score > 12
    18. Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding)
    19. History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
    20. Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
    21. Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
    22. Females who are pregnant or breastfeeding
    23. Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (such as systemic corticosteroids, interleukins, interferons)
    24. Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium–glucose cotransporter 2 (SGLT2) inhibitor, or a thiazolidinedione (TZD) for less than 6 months of stable therapy prior to the liver biopsy at Screening
    25. Receiving ongoing therapy with any disallowed medication between Screening and Baseline visits.
    26. Allergy to the study drug or its components
    27. Receiving any investigational products within 30 days prior to Screening or anticipated use during the trial
    28. Participated in a clinical trial with any investigational product being evaluated for the treatment of liver fibrosis or NASH in the 12 months before Day 1
    29. Participation in any other clinical trial at Screening without approval from the sponsor
    30. Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements
    1. Incapacidad para someterse a una biopsia de hígado
    2. Positivo al antígeno de superficie de la hepatitis B (HBsAg)
    3. Positivo al anticuerpo de la hepatitis C (AcVHC)
    4. Infección por el virus de la inmunodeficiencia humana (VIH-1 o
    VIH-2)
    5. Trasplante hepático previo o previsto
    6. Otras causas conocidas de enfermedad hepática crónica
    7. Antecedentes de presencia de cirrosis y/o descompensación hepática, como ascitis, encefalopatía hepática o hemorragias varicosas
    8. Consumo de alcohol superior a 21 unidades/semana para los hombres o 14 unidades/semana para las mujeres
    9. Aspartato aminotransferasa (AST) > 200 IU/l en hombres y mujeres en la selección
    10. Alanina aminotransferasa (ALT) > 250 IU/l en hombres y > 200 IU/l en mujeres en la selección
    11. Hemoglobina A1c (HbA1c) > 10% en la selección
    12. Albúmina en suero < 3,5 g/dl
    13. Tasa de filtración glomerular (TFG) estimada < 50 ml/min/1,73 m2 según la ecuación de la Modificación de la Dieta en la Enfermedad Renal (MDRD)
    14. Recuento plaquetario < 100.000/mm3
    15. Bilirrubina total > 1,5 mg/dl (los pacientes con hiperbilirrubinemia asociada con síndrome de Gilbert documentado pueden ser aptos previa revisión por parte del supervisor médico)
    16. Índice internacional normalizado (IIN) > 1,3
    17. Puntuación del modelo de hepatopatía en fase terminal > 12
    18. Reducción de peso mediante cirugía bariátrica en los últimos 5 años o prevista durante la realización del estudio (incluyendo la ligadura gástrica)
    19. Antecedentes de neoplasia en los últimos 5 años o neoplasia en curso, salvo carcinoma basocelular y carcinoma de células escamosas cutáneas no invasivo resecado
    20. Infección activa y grave que requiera terapia antibiótica o antifúngica parenteral en un plazo de 30 días antes de la visita de selección
    21. Enfermedad cardiovascular o cerebrovascular clínicamente significativa en los últimos 3 meses
    18. Reducción de peso mediante cirugía bariátrica en los últimos 5 años o prevista durante la realización del estudio (incluyendo la ligadura gástrica)
    19. Antecedentes de neoplasia en los últimos 5 años o neoplasia en curso, salvo carcinoma basocelular y carcinoma de células escamosas cutáneas no invasivo resecado
    20. Infección activa y grave que requiera terapia antibiótica o antifúngica parenteral en un plazo de 30 días antes de la visita de selección
    21. Enfermedad cardiovascular o cerebrovascular clínicamente significativa en los últimos 3 meses
    22. Mujeres embarazadas o que están amamantando
    23. Tratamiento en curso o previsto con radioterapia, agentes quimioterapéuticos citotóxicos y agentes inmunomoduladores (como corticoides sistémicos, interleuquinas o interferones)
    24. Recibir un agonista del receptor del péptido similar al glucagón tipo 1 (GLP-1), un inhibidor de la dipeptidil peptidasa-4 (DPP-4), un inhibidor del cotransportador sodio-glucosa tipo 2 (SGLT2) o una tiazolidinediona (TZD), durante menos de 6 meses de tratamiento estable, antes de la biopsia de hígado de la selección.
    25. Recibir tratamiento constante con algún medicamento no autorizado entre las visitas de selección e inicio
    26. Alergia al fármaco del estudio o a sus componentes
    27. Recibir algún producto experimental durante los 30 días anteriores a la selección o tener previsto su uso durante el ensayo
    28. Haber participado en un ensayo clínico con algún producto experimental que esté siendo evaluado para el tratamiento de la fibrosis hepática o EHNA en los 12 meses anteriores al día 1
    29. Participar en algún otro ensayo clínico en la selección sin la aprobación del promotor
    30. Cualquier otro trastorno clínicamente significativo o tratamiento anterior que, en opinión del investigador, haga al paciente no apto para el estudio o incapaz de cumplir con los requisitos de la administración y el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    (Part 1): Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) on liver histology relative to the Screening biopsy
    (Part 2): Time to first occurrence of any of the following adjudicated events:
    Death (all cause), Histopathologic progression to cirrhosis, Hepatocellular carcinoma, Liver transplant, MELD score ≥15, Ascites , Hospitalization (as defined by a stay of ≥ 24 hours) for onset of: variceal bleed, hepatic encephalopathy (defined by a West Haven Stage of ≥2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis)
    (Parte 1): Proporción de pacientes con mejoría de la fibrosis al menos en 1 etapa (sistema de red de investigación clínica sobre la esteatohepatitis no alcohólica [RIC EHNA]) Y ausencia de agravamiento de la esteatohepatitis (ausencia de agravamiento del grado de inflamación lobular o degeneración balonizante de los hepatocitos) en la histología del hígado en relación a la biopsia de la Selección.
    (Parte 2): Time to first occurrence of any of the following adjudicated events:
    Death (all cause), Histopathologic progression to cirrhosis, Hepatocellular carcinoma (HCC), Liver transplant, MELD score ≥15, Ascites, Hospitalization (as defined by a stay of ≥ 24 hours) for onset of: variceal bleed, hepatic encephalopathy (defined by a West Haven Stage of ≥ 2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: Month 12
    Part 2: Duration of study
    Parte 1: 12 Meses
    Parte 2: Duración del Estudio
    E.5.2Secondary end point(s)
    Parts 1 and 2: Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on steatohepatitis, relative to the Screening biopsy
    Part 2: Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) on liver biopsy relative to the Screening biopsy
    Partes 1 y 2: Proporción de pacientes con mejoría de la fibrosis al menos en 1 etapa (sistema de RIC EHNA), independientemente del efecto en la esteatohepatitis, con respecto a la biopsia de la selección
    Parte 2: Proporción de pacientes con mejoría de la fibrosis al menos en 1 etapa (sistema de red de investigación clínica sobre la esteatohepatitis no alcohólica [RIC EHNA]) Y ausencia de agravamiento de la esteatohepatitis (ausencia de agravamiento del grado de inflamación lobular o degeneración balonizante de los hepatocitos) en la histología del hígado en relación a la biopsia de la Selección.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Months 12 and 60
    Meses 12 y 60
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA110
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Mauritius
    Mexico
    New Zealand
    Norway
    Poland
    Portugal
    Puerto Rico
    Romania
    Singapore
    Spain
    Switzerland
    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
    The primary analysis of Part 1 will occur when approximately 1000 randomized subjects have been followed for at least 12 months. The primary analysis for Part 2 will occur when adjudicated events have been accrued in approximately 240 unique subjects across Part 1 and Part 2.
    El análisis principal de la parte 1 tendrá lugar cuando 1000 pacientes aleatorizados, aproximadamente, hayan sido objeto de seguimiento durante al menos 12 meses. El análisis principal para la parte 2 tendrá lugar cuando se hayan acumulado acontecimientos adjudicados en 240 pacientes concretos, aproximadamente, entre la parte 1 y la parte 2.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    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: 1800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 825
    F.4.2.2In the whole clinical trial 2000
    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)
    Given the planned trial duration of approximately 8 years, subjects are expected to remain in the study until the potential marketing authorization or at the discretion of the investigator.
    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 Decision2017-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-01-08
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