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    Summary
    EudraCT Number:2020-006023-33
    Sponsor's Protocol Code Number:SIMFIB
    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:2021-06-23
    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 number2020-006023-33
    A.3Full title of the trial
    Efficacy of simvastatin reducing liver fibrosis in patients with advanced fibrosis due to alcohol: a randomized, double-blind, placebo-controlled clinical trial.
    Eficacia de la simvastatina para reducir la fibrosis hepática en pacientes con fibrosis avanzada debido al alcohol: un ensayo clínico aleatorizado, doble ciego y controlado con placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of simvastatin for the reduction of alcohol-induced liver fibrosis.
    Efficacy of simvastatin for the reduction of alcohol-induced liver fibrosis.
    A.3.2Name or abbreviated title of the trial where available
    SIMFIB
    SIMFIB
    A.4.1Sponsor's protocol code numberSIMFIB
    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 SponsorInstitut d’Investigacions Biomèdiques August Pi i Sunyer
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstituto Carlos III-Beca FIS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU(clinical Trial Unit)
    B.5.2Functional name of contact pointAnna Cruceta
    B.5.3 Address:
    B.5.3.1Street Addressc/ Mallorca 183, planta 1º, despacho 10
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.6E-mailacruceta@clinic.cat
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameSimvastatin
    D.3.4Pharmaceutical form 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 INNSIMVASTATIN
    D.3.9.1CAS number 79902-63-9
    D.3.9.4EV Substance CodeSUB10529MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number40
    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, soft
    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
    reduction of liver fibrosis in patients with advanced fibrosis due to alcohol
    reducción de la fibrosis hepática en pacientes con fibrosis avanzada por alcohol
    E.1.1.1Medical condition in easily understood language
    reduction of liver fibrosis in patients with advanced fibrosis due to alcohol
    reducción de la fibrosis hepática en pacientes con fibrosis avanzada por alcohol
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10001627
    E.1.2Term Alcoholic liver disease
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10019668
    E.1.2Term Hepatic fibrosis
    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
    Proportion of patients with a significant reduction in the degree of liver fibrosis after treatment with simvastatin compared to placebo, analyzed through the histological evaluation of fibrosis using the Ishak scale, defined as a reduction in the fibrosis value of at least one point on the scale
    Proporción de pacientes que presentan una reducción significativa del grado de fibrosis hepática después del tratamiento con simvastatina en comparación con placebo, analizada a través de la evaluación histológica de la fibrosis mediante la escala Ishak, definida como una reducción del valor de fibrosis de al menos un punto en dicha escala
    E.2.2Secondary objectives of the trial
    1. Analyze the effect of simvastatin on liver fibrosis applied by non-invasive methods:
    a. Transient liver elastography.
    B. Magnetic resonance elastography (MRA).
    C. Serum markers and liver fibrosis score validated for ALD
    2. Study the changes in liver fibrosis and other histological parameters of the disease:
    a. Liver fibrosis
    B. "Proportional area of ​​collagen"
    C. Histological parameters of chronic alcoholic liver disease
    3. Study the effect of simvastatin on the intestinal microbiota.
    4. Analyze the markers of systemic inflammation, immune response, bacterial translocation and endothelial dysfunction:
    a. Proinflammatory cytokines
    B. Bacterial translocation markers
    C. Markers of endothelial dysfunction
    D. Inflammatory profile of circulating immune cells: lymphocytes, monocytes, and neutrophils.
    5. Describe the incidence of adverse effects and the safety of the treatment.
    1. Analizar el efecto de simvastatina sobre la fibrosis hepática evaluada por métodos no invasivos:
    a. Elastografía hepática transitoria.
    b. Elastografía por resonancia magnética (ERM).
    c. Marcadores séricos y “scores” de fibrosis hepática validados para la EHA
    2. Estudiar los cambios en la fibrosis hepática y en otros parámetros histológicos de la enfermedad:
    a. Fibrosis hepática
    b. “Collagen proportional area”
    c. Parámetros histológicos de la enfermedad hepática crónica por alcohol
    3. Estudiar el efecto de la simvastatina sobre la microbiota intestinal.
    4. Analizar los marcadores de inflamación sistémica, respuesta inmune, translocación bacteriana y disfunción endotelial:
    a. Citoquinas proinflamatorias
    b. Marcadores de translocación bacteriana
    c. Marcadores de disfunción endotelial
    d. Perfil inflamatorio de las células inmunes circulantes: linfocitos, monocitos y neutrófilos.
    5. Describir la incidencia de efectos adversos y la seguridad del tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Chronic alcohol-related liver disease according to international guidelines (EASL, European Association for the Study of the Liver) (ishak 3-6)and with data of significant liver fibrosis obtained in the diagnostic biopsy at the beginning of the study or in the last biopsy of the patient within 6 months prior to randomization. Significant liver fibrosis is defined by a score on the Ishak fibrosis scale of between 3 and 6.
    3. Patients in the compensated chronic liver disease phase defined by the absence of clinical decompensations at the time of entering the study, with or without data of portal hypertension.
    4. Women of childbearing potential must have a negative urine pregnancy test prior to study enrollment and agree to use highly effective contraceptive methods (combined oral pill, injectable or implanted contraceptive, intrauterine device / hormone delivery system intrauterine) during the study.
    1. Edad ≥ 18 años
    2. Hepatopatía crónica por alcohol según las guías internacionales (EASL, European Association for the Study of the Liver) y con datos de fibrosis hepática significativa obtenidos en la biopsia diagnóstica al inicio del estudio o en la última biopsia del paciente dentro de los 6 meses previos a la aleatorización. Fibrosis hepática significativa se define por una puntuación en la escala de fibrosis de Ishak de entre 3 y 6.
    3. Pacientes en fase de hepatopatía crónica compensada definida por la ausencia de descompensaciones clínicas en el momento de entrar en el estudio, con o sin datos de hipertensión portal.
    4. Las mujeres en edad fértil deben tener una prueba de embarazo negativa en orina antes de la inclusión en el estudio y usar métodos anticonceptivos altamente eficaces (píldora oral combinada, anticonceptivo inyectable o implantado, dispositivo intrauterino / sistema de liberación de hormonas intrauterina/ DIU) durante el estudio.
    E.4Principal exclusion criteria
    1. Patients receiving statins or fibrates.
    2. Patients with other etiologies of liver disease in addition to alcohol: hepatitis C, hepatitis B, autoimmune hepatitis, Wilson's disease, or hemochromatosis.
    3. Patients in whom hepatitis C has been cured with antivirals in the 2 years prior to inclusion in the study.
    4. Patients with a CK elevation of 50% or more above the upper limit of normal at the time of study inclusion.
    5. Gastrointestinal bleeding due to portal hypertension within 12 months prior to inclusion in the study.
    6. Clinical hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy, in the 12 months prior to inclusion in the study.
    7. Patients in need of diuretic treatment in the previous 12 months to control ascites or hydrothorax.
    8. Spontaneous bacterial peritonitis within 12 months prior to study enrollment.
    9.Child-Pugh > 8
    10. Hepatocellular carcinoma of any stage.
    11. Patients with known muscle disease.
    12. Patients with previous rhabdomyolysis.
    13. Patients being treated with strong CYP3A4 enzyme inhibitors (see section 5.2: Concomitant drugs, not allowed and allowed).
    14. Patients being treated with drugs with possible interactions with simvastatin (see section 5.2: Concomitant drugs, not allowed and allowed).
    15. Patients with a history of significant extrahepatic disease with poor short-term prognosis, including New York Heart Association Grade III / V congestive heart failure, GOLD COPD> 2, chronic kidney disease with serum creatinine> 2mg / dL or under therapy of kidney replacement.
    16. Patients with extrahepatic malignancies, including solid tumors and hematologic malignancies.
    17. Patients with a history or increased risk of intestinal obstruction.
    18. Pregnancy or breastfeeding.
    19. Patients included in other clinical trials during the previous month.
    20. Patients with mental disabilities, language barriers, poor social support or any other reason considered by the researcher as essential for adequate understanding, cooperation or compliance with the study.
    21. Presence of data on alcoholic hepatitis in liver biopsy upon inclusion.
    22. Patients with contraindications for statins.
    23. Known hypersensitivity to simvastatin.
    24. Refusal to sign the informed consent.
    1. Pacientes en tratamiento con estatinas o fibratos.
    2. Pacientes con otras etiologías de hepatopatía además del alcohol: hepatitis C, hepatitis B, hepatitis autoinmune, enfermedad de Wilson o hemocromatosis.
    3. Pacientes en los que se ha curado la hepatitis C con antivirales en los 2 años previos a la inclusión en el estudio.
    4. Pacientes con una elevación de CK del 50% o más por encima del límite superior de la normalidad en el momento de la inclusión en el estudio.
    5. Sangrado gastrointestinal por hipertensión portal dentro de los 12 meses previos a la inclusión en el estudio.
    6. Encefalopatía hepática clínica, definida como encefalopatía hepática de grado II-IV, en los 12 meses previos a la inclusión en el estudio.
    7. Pacientes con necesidad de tratamiento con diuréticos en los 12 meses previos para control de la ascitis o hidrotórax.
    8. Peritonitis bacteriana espontánea dentro de los 12 meses previos a la inclusión en el estudio.
    9. Pacientes con puntuación Child-Pugh > 8 puntos.
    10.Carcinoma hepatocelular en cualquier estadio.
    11. Pacientes con enfermedad muscular conocida.
    12. Pacientes con rabdomiolisis previa.
    13. Pacientes en tratamiento con inhibidores potentes de la enzima CYP3A4 (ver sección 5.2: Medicamentos concomitantes, no permitidos y permitidos).
    14. Pacientes en tratamiento con medicamentos con posibles interacciones con simvastatina (ver sección 5.2: Medicamentos concomitantes, no permitidos y permitidos).
    15. Pacientes con antecedentes de enfermedad extrahepática significativa con mal pronóstico a corto plazo, incluyendo insuficiencia cardíaca congestiva Grado III/V de la New York Heart Association, EPOC GOLD >2, enfermedad renal crónica con creatinina sérica >2mg/dL o bajo terapia de reemplazo renal.
    16. Pacientes con neoplasias malignas extrahepáticas, incluidos tumores sólidos y neoplasias hematológicas.
    17. Pacientes con antecedentes o mayor riesgo de obstrucción intestinal.
    18. Embarazo o lactancia.
    19. Pacientes incluidos en otros ensayos clínicos durante el mes previo.
    20. Pacientes con discapacidad mental, barrera idiomática, mal apoyo social o cualquier otra razón considerada por el investigador como imprescindible para la comprensión, cooperación o cumplimiento adecuados en el estudio.
    21. Presencia de datos de hepatitis alcohólica en la biopsia hepática a la inclusión.
    22. Pacientes con contraindicaciones para estatinas.
    23. Hipersensibilidad conocida a la simvastatina.
    24. Negativa a firmar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with a significant reduction in the degree of liver fibrosis after treatment with simvastatin compared to placebo, analyzed through the histological evaluation of fibrosis using the Ishak scale, defined as a reduction in the fibrosis value of at least one point on this scale
    Proporción de pacientes que presentan una reducción significativa del grado de fibrosis hepática después del tratamiento con simvastatina en comparación con placebo, analizada a través de la evaluación histológica de la fibrosis mediante la escala Ishak, definida como una reducción del valor de fibrosis de al menos un punto en dicha escala
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline biopsy in histological fibrosis score measured using the Ishak scale at 6,12,18 months.
    Cambio respecto a la biopsia basal en la puntuación de fibrosis histológica medido a través de la escala de Ishak a los 6,12 y 18 meses.
    E.5.2Secondary end point(s)
    1. Analyze the effect of simvastatin on liver fibrosis evaluated by non-invasive methods:
    to. Change in liver elasticity measured by transient liver elastography at 6, 12, and 18 months.
    b. Change in liver elasticity measured by ERM at 18 months.
    c. Changes in serum markers and liver fibrosis scores validated for ALD and widely used in the general population: FIB-4 (Fibrosis Index for Liver Fibrosis) and ELF (Enhanced liver Fibrosis), pro-collagen 3, hydroxyproline, metalloproteinase 1 and telopeptide, at 18 months.
    2. Study the changes in liver fibrosis and other histological parameters of the disease:
    d. Changes in liver fibrosis assessed using the Metavir scale, the EPOS scale and the “7-tier fibrosis staging system for ALD” scale, at 18 months.
    and. Change in the “collagen proportional area” or area occupied by collagen in liver biopsies stained using psirious network and analyzed with Image J software, at 18 months.
    F. Changes in histological parameters of chronic alcoholic liver disease: steatosis, neutrophil infiltration, Mallory's hyaline, ballooning of hepatocytes, etc .; at 18 months.
    3. Changes in the diversity and taxonomic composition of the intestinal microbiota by massive sequencing, at 18 months of treatment.
    4. Analyze the markers of systemic inflammation, immune response, bacterial translocation and endothelial dysfunction:
    and. Change in levels of pro-inflammatory cytokines associated with alcoholic liver disease: IL-6, TNFα, and procalcitonin; at 18 months.
    F. Change in levels of bacterial translocation markers: bacterial lipopolysaccharide and lipopolysaccharide-bound protein; at 18 months.
    g. Change in levels of endothelial dysfunction markers: nitric oxide (NO), Von Willebrand factor (vWF); at 18 months.
    h. Change in the inflammatory profile of circulating immune cells: lymphocytes, monocytes and neutrophils; at 18 months.
    5. analyse gen SLCO1B1 polimorfism and muscular toxicity
    6.Incidence of adverse effects and safety of treatment
    1. Analizar el efecto de simvastatina sobre la fibrosis hepática evaluada por métodos no invasivos:
    a. Cambio en la elasticidad hepática medido a través de elastografía hepática transitoria a los 6, 12 y 18 meses.
    b. Cambio en la elasticidad hepática medido a través de ERM a los 18 meses.
    c. Cambios en los marcadores séricos y “scores” de fibrosis hepática validados para la EHA y ampliamente utilizados en población general: FIB-4 (Fibrosis Index for Liver Fibrosis) y ELF (Enhanced liver Fibrosis), pro-colágeno 3, hidroxiprolina, metaloproteinasa 1 y telopéptido, a los 18 meses.
    2. Estudiar los cambios en la fibrosis hepática y en otros parámetros histológicos de la enfermedad:
    d. Cambios en la fibrosis hepática evaluada mediante la escala Metavir, la escala EPOS y la escala “7-tier fibrosis staging system for ALD”, a los 18 meses.
    e. Cambio en el “collagen proportional area” o área ocupada por colágeno en biopsias hepáticas teñidas mediante psirious red y analizadas con el software Image J, a los 18 meses.
    f. Cambios en parámetros histológicos de la enfermedad hepática crónica por alcohol: esteatosis, infiltración por neutrófilos, hialina de Mallory, balonización de hepatocitos, etc.; a los 18 meses.
    3. Cambios en la diversidad y composición taxonómica de la microbiota intestinal mediante secuenciación masiva, a los 18 meses de tratamiento.
    4. Analizar los marcadores de inflamación sistémica, respuesta inmune, translocación bacteriana y disfunción endotelial:
    e. Cambio en los niveles de citoquinas proinflamatorias asociadas a la enfermedad hepática por alcohol: IL-6, TNFα y procalcitonina; a los 18 meses.
    f. Cambio en los niveles de marcadores de translocación bacteriana: lipopolisacárido bacteriano y la proteína ligada al lipopolisacárido; a los 18 meses.
    g. Cambio en los niveles de marcadores de disfunción endotelial: óxido nítrico (NO), factor de Von Willebrand (vWF); a los 18 meses.
    h. Cambio en el perfil inflamatorio de las células inmunes circulantes: linfocitos, monocitos y neutrófilos; a los 18 meses.
    5. Analizar los polimorfismos del gen SLCO1B1 y su relación con la toxicidad muscular
    6. Incidencia de efectos adversos y seguridad del tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.
    to. Transient liver elastography at 6, 12, and 18 months.
    b. ERM at 18 months.
    c. FIB-4 and ELF, pro-collagen 3, hydroxyproline, metalloproteinase 1 and telopeptide, at 18 months.
    two.
    d. Changes in liver fibrosis with 3 different scales at 18 months
    and. Change in the “collagen proportional area” in liver biopsies at 18 months
    F. Changes in histological parameters at 18 months
    3. Changes in the intestinal microbiota by massive sequencing, at 18 months
    4. e.Change in: IL-6, TNFα and procalcitonin; at 18 months
    F. Bacterial lipopolysaccharide and protein change at 18 months.
    g. Change in: nitric oxide, Von Willebrand factor at 18 months.
    h. Immune changes at 18 months
    5. Incidence of adverse effects and safety of treatment
    1.
    a. elastografía hepática transitoria a los 6, 12 y 18 meses.
    b. ERM a los 18 meses.
    c. FIB-4 y ELF , pro-colágeno 3, hidroxiprolina, metaloproteinasa 1 y telopéptido, a los 18 meses.
    2.
    d. Cambios en la fibrosis hepática con 3 escalas diferentes a los 18 meses
    e. Cambio en el “collagen proportional area” en biopsias hepáticas a los 18 meses
    f. Cambios en parámetros histológicos a los 18 meses
    3. Cambios en microbiota intestinal mediante secuenciación masiva, a los 18 meses
    4. e.Cambio en : IL-6, TNFα y procalcitonina; a los 18 meses
    f. Cambio lipopolisacárido bacteriano y proteína a los 18 meses.
    g. Cambio en: óxido nítrico , factor de Von Willebrand a los 18 meses.
    h. Cambios inmunológicos a 18 meses
    5. Incidencia de efectos adversos y seguridad del tratamiento
    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 No
    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) 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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state90
    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)
    none
    ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation beca FIS PI20/00579 Instituto de Salud Carlos III
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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