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    Summary
    EudraCT Number:2015-004336-35
    Sponsor's Protocol Code Number:IDN-6556-12
    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:2016-03-18
    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 number2015-004336-35
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
    of Emricasan (IDN-6556), an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis
    Ensayo multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar emricasán (IDN 6556), un inhibidor de la caspasa de administración oral, en sujetos con fibrosis por esteatohepatitis no alcohólica (EHNA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of ?definite NASH? with fibrosis (excluding cirrhosis).
    Ensayo multicéntrico, aleatorizado, doble ciego y controlado con placebo para sujetos con un diagnóstico de ?EHNA definitivo? con fibrosis (sin cirrosis).
    A.4.1Sponsor's protocol code numberIDN-6556-12
    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 SponsorConatus Pharmaceuticals 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 supportConatus Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConatus Pharmaceuticals Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address16745 W. Bernardo Drive, Suite 200
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92127
    B.5.3.4CountryUnited States
    B.5.4Telephone number34900834223
    B.5.5Fax number...
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameEmricasan
    D.3.2Product code IDN-6556
    D.3.4Pharmaceutical form Capsule
    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 INNEmricasan
    D.3.9.1CAS number 254750-02-2
    D.3.9.2Current sponsor codeIDN-6556
    D.3.9.3Other descriptive nameEMRICASAN
    D.3.9.4EV Substance CodeSUB88543
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nameEmricasan
    D.3.2Product code IDN-6556
    D.3.4Pharmaceutical form Capsule
    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 INNEmricasan
    D.3.9.1CAS number 254750-02-2
    D.3.9.2Current sponsor codeIDN-6556
    D.3.9.3Other descriptive nameEMRICASAN
    D.3.9.4EV Substance CodeSUB88543
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCapsule
    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
    E.1.1.1Medical condition in easily understood language
    Fibrosis due to NASH
    Fibrosis debido a EHNA
    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 18.1
    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
    To assess whether treatment with emricasan compared to matching placebo in subjects with NASH fibrosis improves fibrosis on liver biopsy by at least one stage without worsening of steatohepatitis using the NASH Clinical Research Network (CRN) Histologic Scoring System.
    Evaluar si el tratamiento con emricasán comparado con placebo equivalente en sujetos con fibrosis por EHNA mejora la fibrosis en biopsia hepática al menos en un estadio, sin empeoramiento de la esteatohepatitis, según el sistema de puntuación histológico de la Red de Investigación Clínica (Clinical Research Network, CRN) sobre EHNA.
    E.2.2Secondary objectives of the trial
    - To assess the safety and tolerability of emricasan in subjects with NASH fibrosis, including any potential effects on metabolic parameters (insulin resistance, glycemic control, lipid levels)
    - To assess whether emricasan compared to placebo can resolve steatohepatitis without worsening of fibrosis in subjects with NASH fibrosis
    - To assess whether emricasan compared to placebo can improve NAFLD Activity Score (NAS), its components (steatosis, lobular inflammation, ballooning), and portal inflammation in subjects with NASH fibrosis
    - To assess whether emricasan compared to placebo can improve collagen and fat content based on liver biopsy morphometry in subjects with NASH fibrosis
    - To assess whether emricasan compared to placebo improves biomarkers (caspase 3/7, cCK18/M30, flCK18/M65, ALT, AST, serum fibrosis markers) in subjects with NASH fibrosis
    - To assess whether emricasan compared to placebo improves health-related quality of life in subjects with NASH fibrosis
    -Evaluar la seguridad y tolerabilidad de emricasán en sujetos con fibrosis por EHNA, incluyendo cualquier posible efecto en los parámetros metabólicos (resistencia a la insulina, control de la glucemia y concentraciones de lípidos)
    -Evaluar si emricasán comparado con placebo puede resolver la esteatohepatitis sin empeoramiento de la fibrosis en sujetos con fibrosis por EHNA
    -Evaluar si emricasán comparado con placebo puede mejorar el índice de actividad de EsHNA (NAS), sus componentes (esteatosis, inflamación lobulillar, balonización)y la inflamación portal en sujetos con fibrosis por EHNA
    Evaluar si emricasán comparado con placebo puede mejorar el contenido de colágeno y grasa según la morfometría de la biopsia hepática en sujetos con fibrosis por EHNA
    Evaluar si emricasán comparado con placebo mejora los biomarcadores (caspasa 3/7, cCK18/M30, flCK18/M65, ALT, AST, marcadores de fibrosis en suero) en sujetos con fibrosis por EHNA
    por EHNA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects 18 years or older, able to provide written informed consent, and able to understand and willing to comply with the requirements of the study
    2. Histological evidence of definite NASH based on NASH CRN criteria, as confirmed by the central histopathologist, on a liver biopsy obtained no more than 6 months prior to Day 1
    3. NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2)
    4. Fibrosis stage 1 (limited to 20% of subjects), stage 2, or stage 3 using the NASH CRN Histologic Scoring System
    a. Subjects with fibrosis stage 1 must also have diabetes mellitus or metabolic syndrome
    5. Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug
    6. If on vitamin E or pioglitazone, subjects must have been on a stable dose for at least 3 months prior to the biopsy (whether historical or qualifying biopsy)
    1.Varones o mujeres mayores de 18 años, capaces de otorgar su consentimiento informado por escrito, y capaces de comprender y dispuestos a cumplir los requisitos del estudio
    2.Evidencia histológica de EHNA confirmada conforme a los criterios de la CRN sobre EHNA, confirmada por el histopatólogo central, en una biopsia hepática obtenida en un plazo no superior a 6 meses antes del día 1
    3.Índice de actividad de EsHNA (NAS) de 4 o superior, con una puntuación mínima de 1 en cada componente de NAS (puntuación de esteatosis de 0-3, de inflamación lobulillar de 0-3 y de balonización de 0-2)
    4.Estadio de fibrosis 1 (limitado al 20 % de los sujetos), estadio 2 o estadio 3, según el sistema de puntuación histológico de la CRN sobre EHNA
    a. Los sujetos con estadio 1 de fibrosis deben presentar también diabetes mellitus o síndrome metabólico (según la definición armonizada de 2009) [1]
    5.Disposición a utilizar métodos anticonceptivos eficaces (tanto varones como mujeres en edad fértil) desde la fase de selección hasta 4 semanas después de la última dosis del fármaco del estudio
    6.Si están en tratamiento con vitamina E o pioglitazona, los sujetos deberán haber recibido una dosis estable durante los últimos 3 meses antes de la biopsia (tanto si se trata de biopsia histológica como obtenida en selección)
    E.4Principal exclusion criteria
    1. Current or history of significant alcohol consumption, defined as more than 20 g/day for females and more than 30 g/day in males on average, or inability to reliably quantify alcohol consumption based on investigator?s judgement
    2. Use of the following drugs (which may have potential hepatotoxic effects) within 6 months prior to Day 1: amiodarone, methotrexate, tamoxifen, valproic acid, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, systemic glucocorticoids for more than 4 weeks at doses greater than replacement doses
    3. Uncontrolled diabetes (glycated hemoglobin [HbA1c] ?9%) within 60 days prior to Day 1
    4. Presence of cirrhosis on liver biopsy (fibrosis stage 4 based on the central histopathologist reading)
    5. Evidence of other forms of chronic liver disease such as:
    a. autoimmune hepatitis
    b. active infection with hepatitis B virus (HBV)
    c. hepatitis C virus (HCV) infection
    d. primary biliary cirrhosis
    e. primary sclerosing cholangitis
    f. Wilson?s disease
    g. alpha-1-antitrypsin deficiency
    h. hemochromatosis or iron overload
    i. drug-induced liver disease
    j. other biliary liver disease
    6. ALT or AST >5 times upper limit of normal (ULN) or total bilirubin >1.5 times ULN during screening (unless subject has elevated total bilirubin due to Gilbert?s as documented in the medical records)
    7. Alpha-fetoprotein >100 ng/mL
    8. Hemoglobin <10 g/L
    9. White blood cell (WBC) count <3.0 × 109/L
    10. Severe renal impairment defined as eGFR (estimated glomerular filtration rate) of less than 50 mL/min/1.73 m2
    11. Current use of the following medications that are considered significant inhibitors of OATP1B1 and OATP1B3 transporters (atazanavir, cyclosporine, eltrombopag,
    gemfibrozil, indinavir, lopinavir, ritonavir, rifampin, saquinavir, simeprevir, telaprevir, tipranovir, or some combination of these medications)
    12. Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months
    13. Inability to safely obtain a liver biopsy
    14. Known human immunodeficiency virus (HIV) infection
    15. Any subject who has made a significant lifestyle change to their diet and/or exercise regimens within 3 months prior to Day 1 or plans to do so during the study
    16. Abuse of controlled substances (including inhaled or injected drugs) or nonprescribed use of prescription drugs within 1 year of screening
    17. History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
    18. Significant systemic or major illness other than liver disease that in the opinion of the investigator would preclude the subject from participating in and completing the study, including but not limited to acute coronary syndrome or stroke within 6 months of screening or major surgery within 3 months of screening
    19. History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QTcF interval >480 milliseconds (msec)
    20. Prior or planned bariatric surgery
    21. If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
    22. Previous treatment with emricasan or active investigational medication in a clinical trial within 6 months prior to Day 1
    1.Antecedentes o consumo actual importante de alcohol, definido como una media de más de 20 g/día en el caso de mujeres y más de 30 g/día en varones, o imposibilidad de cuantificar de manera fiable el consumo de alcohol según el criterio del investigador
    2.Consumo de los siguientes fármacos (que pueden tener posibles efectos hepatotóxicos) en los 6 meses anteriores al día 1: amiodarona, metotrexato, tamoxifeno, ácido valproico, estrógenos a dosis superiores a las utilizadas para tratamientos hormonales sustitutivos o como anticonceptivos, esteroides anabolizantes, glucocorticoides sistémicos durante más de 4 semanas a dosis superiores a las de sustitución
    3.Diabetes no controlada (hemoglobina glucosilada [HbA1c] ? 9 %) en el plazo de 60 días antes del día 1
    4.Presencia de cirrosis en biopsia hepática (estadio de fibrosis 4 según la medición del histopatólogo central)
    5.Evidencia de otras formas de hepatopatía crónica como:
    a.Hepatitis autoinmune
    b.Infección activa por el virus de la hepatitis B (VHB)
    c.Infección por el virus de la hepatitis C (VHC)
    d.Cirrosis biliar primaria
    e.Colangitis esclerosante primaria
    f.Enfermedad de Wilson
    g.Déficit de alfa-1-antitripsina
    h.Hemocromatosis o sobrecarga de hierro
    i.Hepatopatía de origen farmacológico
    j.Otra enfermedad hepática o biliar
    6.ALT o AST > 5 veces por encima del límite normal (LSN) o bilirrubina total > 1,5 veces el LSN durante la selección (salvo que el sujeto presente elevación de la bilirrubina total producida por un síndrome de Gilbert según lo documentado en los registros médicos)
    7.Alfa-fetoproteína > 100 ng/ml
    8.Hemoglobina < 10 g/l
    9.Recuento de leucocitos < 3,0 x 109/l
    10.lnsuficiencia renal grave definida como un índice de FGe (filtración glomerular estimada) inferior a 50 ml/min/1,73 m2
    11.Tratamiento actual con los siguientes medicamentos que se consideran inhibidores importantes de los transportadores OATP1B1 y OATP1B3 (atazanavir, ciclosporina, eltrombopag, gemfibrozilo, indinavir, lopinavir, ritonavir, rifampicina, saquinavir, simeprevir, telaprevir, tipranovir o alguna combinación de estos medicamentos)
    12.Síntomas de cólico biliar, por ejemplo, debido a cálculos biliares sintomáticos, en los últimos 6 meses
    13.Imposibilidad de obtener una biopsia hepática de forma segura
    14.Infección conocida por el virus de la inmunodeficiencia humana (VIH).
    15.Cualquier sujeto que haya realizado algún cambio importante de estilo de vida en su dieta o régimen de ejercicio en los 3 meses anteriores al día 1 o tenga previsto hacerlo durante el estudio
    16.Abuso de sustancias controladas (incluidos fármacos inhalados o inyectados) o consumo no prescrito de fármacos con receta durante el plazo de 1 año antes de la fase de selección
    17.Antecedentes de neoplasia maligna activa, salvo las tratadas con éxito de forma curativa y que se consideren curadas
    18.Enfermedades importantes o sistémicas significativas distintas de hepatopatía y que, en opinión del investigador, impidan la participación del sujeto en el estudio o que pueda completarlo, por ejemplo: síndrome coronario agudo o ictus en los 6 meses previos a la fase de selección, o cirugía mayor en los 3 meses previos a dicha fase de selección
    19.Antecedentes o presencia de arritmias cardíacas preocupantes desde el punto de vista clínico, o prolongación del intervalo QTcF > 480 milisegundos (ms) en el periodo de selección (antes del tratamiento)
    20.Cirugía bariátrica anterior o programada
    21.En mujeres: embarazo planificado o conocido, prueba de embarazo en orina o suero positiva, o lactancia
    22.Tratamiento previo con emricasán o medicamento activo en investigación en un ensayo clínico en un plazo de 6 meses antes del día 1
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in fibrosis stage at 72 weeks;
    All subjects who complete the study will have a liver biopsy at week 72. Subjects discontinuing the study early will be contacted and asked to sign a separate consent to return for a week 72 liver biopsy.
    Cambio desde el momento basal en el estadio de fibrosis a las 72 semanas;
    Los sujetos que completen el estudio se someteran a una biopsia hepática en la semana 72 .
    A los sujetos que abandonen el estudio de forma prematura se les llamará y pedirá que firmen un consentimiento por separado para volver a la semana 72 con el fin de someterse a una biopsia hepática
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 72
    Semana 72
    E.5.2Secondary end point(s)
    - Resolution of steatohepatitis (no ballooning and no more than 1 point in
    inflammation) without worsening of fibrosis
    - Decrease in NAS of at least 2 points without worsening of fibrosis
    -Resolución de la esteatohepatitis (ausencia de balonización y una puntuación de la inflamación no mayor de 1) sin empeoramiento de la fibrosis
    -Reducción en el NAS de al menos 2 puntos sin empeoramiento de la fibrosis
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 72
    Semana 72
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    POP PK
    Evaluación farmacocinética (FC) de la población
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Germany
    Spain
    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
    UVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 264
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 66
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 330
    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)
    As per protocol.
    De acuerdo al protocolo.
    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 Decision2016-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-29
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