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    Summary
    EudraCT Number:2016-004599-23
    Sponsor's Protocol Code Number:GSN000300
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-04
    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 number2016-004599-23
    A.3Full title of the trial
    A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase
    Ensayo clínico doble ciego, aleatorizado y controlado con placebo para evaluar la eficacia y la seguridad de GKT137831 oral en pacientes con colangitis biliar primaria tratados con ácido ursodesoxicólico y con fosfatasa alcalina persistentemente elevada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase
    Un estudio para evaluar la eficacia y la seguridad de GKT137831 en pacientes con colangitis biliar primaria que están siendo tratados con ácido ursodesoxicólico y que tienen la fosfatasa alcalina siempre elevada
    A.4.1Sponsor's protocol code numberGSN000300
    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 SponsorGenkyotex SA
    B.1.3.4CountryFrance
    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 supportGenkyotex Innovation SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenkyotex Innovation SA
    B.5.2Functional name of contact pointIsabelle Aelbrecht
    B.5.3 Address:
    B.5.3.1Street Address516, rue Pierre et Marie Curie
    B.5.3.2Town/ cityLabège
    B.5.3.3Post code31670
    B.5.3.4CountryFrance
    B.5.4Telephone number+34932275753
    B.5.6E-mailisabelle.aelbrecht@genkyotex.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.3.2Product code GKT137831
    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 INNGKT137831
    D.3.9.1CAS number 1218942-37-0
    D.3.9.3Other descriptive nameGKT137831
    D.3.9.4EV Substance CodeSUB57852
    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 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
    Primary Biliary Cholangitis
    Colangitis biliar primaria
    E.1.1.1Medical condition in easily understood language
    Primary Biliary Cholangitis
    Colangitis biliar primaria
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036680
    E.1.2Term Primary biliary cirrhosis
    E.1.2System Organ Class 100000023866
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of oral GKT137831 in comparison with placebo, in subjects with PBC receiving UDCA and with persistently elevated Alkaline Phosphatase (ALP).
    Evaluar la eficacia de GKT137831 oral en comparación con placebo en sujetos con CBP tratados con AUDC y con fosfatasa alcalina (FA) persistentemente elevada.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety of oral GKT137831 in comparison with placebo, in subjects with PBC.
    - To estimate the population pharmacokinetics (PK) of GKT137831 and explore any potential Pharmacokinetics-Pharmacodynamics (PK-PD) relationships in this subject population.
    - To explore any relationship between genetic parameters and therapeutic responses in a subset of subjects.
    - Evaluar la seguridad de GKT137831 oral en comparación con placebo en sujetos con CBP.
    - Calcular los parámetros farmacocinéticos (FC) de GKT137831 en la población y analizar cualquier posible relación entre la farmacocinética y la farmacodinámica (FC-FD) en esta población de sujetos.
    - Analizar cualquier relación entre los parámetros genéticos y las repuestas terapéuticas en un subgrupo de sujetos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    1. Male or female aged 18 to 80 years, inclusive.
    2. Willing and able to give written informed consent and to comply with the requirements of the study.
    3. PBC diagnosis as demonstrated by the presence of > or = 2 of the following 3 diagnostic factors:
    -History of elevated ALP levels (> ULN) for at least 6 months
    -Positive anti-mitochondrial antibody (AMA) titer or if AMA negative or in low titer (< 1:80) PBC-specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex])
    -Liver biopsy consistent with PBC (based on historic liver biopsy), including non-suppurative, destructive cholangitis affecting mainly the interlobular and septal bile ducts.
    4. Serum ALP > or = 1.5 x ULN.
    5. Serum GGT > or = 1.5 x ULN.
    6. UDCA treatment for at least 6 months and stable dose for at least 3 months prior to Visit 1.
    7. Subjects being treated for pruritus with colestyramine must be on a stable dose of colestyramine for at least 8 weeks prior to baseline/Day 1 (Visit 2). Subjects must be willing and able to take colestyramine at least 2 hours before or after study medication.
    8. Female subjects of childbearing potential must use a highly effective method of contraception to prevent pregnancy for 4 weeks before randomization and must agree to continue strict contraception for 90 days after last administration of investigational medicinal product (IMP). Male participants with female partners of childbearing potential must be willing to use a condom and require their partner to use an additional form of adequate contraception as approved by the Investigator. This requirement begins at the time of informed consent and ends 90 days after the last administration of IMP. Male study participants must also not donate sperm from baseline until 90 days after the last administration of IMP.
    Criterios de inclusión:
    1. Hombre o mujer de entre 18 y 80 años de edad, ambos incluidos.
    2. Dispuesto y capaz de otorgar consentimiento informado escrito y de respetar las obligaciones del estudio.
    3. Diagnóstico de CBP demostrado mediante la presencia de al menos dos de los tres factores de diagnóstico siguientes:
    - Historial de niveles de FA elevados (superiores al LSN) durante al menos 6 meses.
    - Nivel de anticuerpos antimicondriales (AMA) positivo o, en caso de que sea negativo o bajo (<1:80), anticuerpos específicos de CBP (anti-GP210 y/o anti-SP100 y/o anticuerpos contra los principales componentes M2 [PDC-E2, complejo ácido 2-oxoglutárico deshidrogenasa]).
    - Biopsia hepática consistente con CBP (según historial de biopsias hepáticas), incluyendo colangitis destructiva no supurativa que afecte principalmente a los conductos biliares interlobulares y septales.
    4. FA en suero > o = 1,5 veces el LSN.
    5. GGT en suero > o = 1,5 veces el LSN.
    6. Tratamiento con AUDC durante al menos 6 meses y dosis estable durante al menos 3 meses antes de la visita 1.
    7. Los sujetos tratados de pruritos con colestiramina deberán mantener una dosis estable de colestiramina durante al menos 8 semanas antes de la visita inicial/día 1 (visita 2). Los sujetos deberán estar dispuestos a tomar colestiramina al menos 2 horas antes o después de la medicación del estudio.
    8. Las participantes mujeres en edad fértil deberán utilizar métodos anticonceptivos altamente eficaces para evitar el embarazo durante 4 semanas antes de la aleatorización y deberán aceptar continuar con el uso estricto de anticonceptivos durante 90 días tras la última administración del producto médico en fase de investigación (PMI). Los participantes masculinos con parejas que sean mujeres en edad fértil deberán estar dispuestos a utilizar preservativos e instar a su pareja a utilizar un método adicional de anticoncepción adecuado y aprobado por el Investigador. Este requisito entrará en vigor desde el momento en que se entregue el consentimiento informado y finalizará 90 días después de la última administración del PMI. Asimismo, los hombres que participen en el estudio no deberán donar semen desde la visita inicial y hasta pasados 90 días tras la última administración del PMI.
    E.4Principal exclusion criteria
    1. A positive pregnancy test or breast-feeding for female subjects.
    2. Any hepatic decompensation, defined as a past or current history of hepatic encephalopathy, gastrointestinal tract bleeding due to esophageal varices, or ascites
    3. International normalized ratio (INR) > 1.2 unless subject is on anticoagulant therapy.
    4. ALT > 3 x ULN.
    5. Total bilirubin > 1 x ULN.
    6. Planned or current plasmapheresis or other extra-corporeal treatments (e.g., molecular adsorbent recirculation system (MARS)) for treatment-refractory pruritus.
    7. History of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score > or = 15.
    8. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma.
    9. Hepatorenal syndrome (type I or II) or Screening serum creatinine > ULN
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    7. Subjects being treated for pruritus with colestyramine must be on a
    stable dose of colestyramine for at least 8 weeks prior to baseline/Day 1
    (Visit 2). Subjects must be willing and able to take colestyramine at
    least 2 hours before or after study medication.
    8. Female subjects of childbearing potential must use a highly effective
    method of contraception to prevent pregnancy for 4 weeks before
    randomization and must agree to continue strict contraception for up to
    90 days after last administration of investigational medicinal product
    (IMP). Male participants with female partners of childbearing potential
    must be willing to use a condom and require their partner to use an
    additional form of adequate contraception as approved by the
    Investigator. This requirement begins at the time of informed consent
    and ends 90 days after the last administration of IMP. Male study
    participants must also not donate sperm from baseline until 90 days
    after the last administration of IMP.

    E.4 PRINCIPAL EXCLUSION CRITERIA (list the most important)
    English 1. A positive pregnancy test or breast-feeding for female subjects.
    2. Any hepatic decompensation, defined as a past or current history of
    hepatic encephalopathy, gastrointestinal tract bleeding due to
    esophageal varices, or ascites
    3. International normalized ratio (INR) > 1.2 unless subject is on
    anticoagulant therapy.
    4. ALT > 3 x ULN.
    5. Total bilirubin > 1 x ULN.
    6. Planned or current plasmapheresis or other extra-corporeal
    treatments (e.g., molecular adsorbent recirculation system (MARS)) for
    treatment-refractory pruritus.
    7. History of liver transplantation, current placement on a liver
    transplant list or current Model for End Stage Liver Disease (MELD) score
    ≥ 15.
    8. Cirrhosis with complications, including history or presence of:
    spontaneous bacterial peritonitis, hepatocellular carcinoma.
    9. Hepatorenal syndrome (type I or II) or Screening serum creatinine >
    ULN.
    10. Competing etiology for liver disease (e.g., hepatitis C, active
    hepatitis B, non-alcoholic steatohepatitis (NASH), alcoholic liver disease
    (ALD), autoimmune hepatitis, primary sclerosing cholangitis, Gilbert's
    Syndrome).
    11. Subjects receiving prohibited medications within 3 months of
    Screening (Visit 1) according to the list (a, b and c) provided in Section
    6.6.2.
    12. Treatment with any investigational agent within 4 weeks of Visit 1 or
    5 half-lives of the investigational medicinal product (whichever is
    longer).
    13. A history of long QT syndrome.
    14. Evidence of any of the following cardiac conduction abnormalities
    during the screening period:
    - A QTc Fredericia interval >450 milliseconds for males and >470
    milliseconds for females.
    - A second or third degree atrioventricular block not successfully treated
    with a pacemaker.
    15. History of cancer in the preceding 5 years, except adequately treated
    non-melanoma skin cancer, carcinoma in situ of the cervix, in situ
    prostate cancer, in situ breast ductal carcinoma, or superficial bladder
    cancer stage 0).
    16. The occurrence of any acute infection requiring systemic antibiotic therapy within the 2 weeks prior the Screening Visit (Visit 1), or human
    immunodeficiency virus (HIV) infection.
    17. A history of bone marrow disorder including aplastic anemia, or
    marked anemia defined as hemoglobin < 10.0 g/dL (or 6.2 mmol/L).
    18. Any condition which, in the opinion of the Investigator, constitutes a
    risk or contraindication for the participation of the subject in the study,
    or which could interfere with the study objectives, conduct, or
    evaluation.
    1. Para las mujeres, prueba de embarazo positiva o lactancia.
    2. Cualquier descompensación hepática, definida como un historial anterior o actual de encefalopatía hepática, sangrado gastrointestinal debido a varices esofágicas o ascitis.
    3. Índice internacional normalizado (IIN) >1,2 salvo que el sujeto esté en tratamiento anticoagulante.
    4. ALT >3 veces el LSN.
    5. Bilirrubina total >1 vez el LSN.
    6. Plasmaféresis planificada o actual, u otros tratamientos extracorpóreos (por ejemplo, el sistema de recirculación molecular absorbente [MARS]) para el prurito resistente al tratamiento.
    7. Historial de trasplante hepático, inclusión actual en una lista de trasplante hepático o puntuación actual > o = 15 en la escala MELD (modelo de enfermedad hepática terminal).
    8. Cirrosis con complicaciones, incluyendo historial o presencia de: peritonitis bacteriana espontánea y carcinoma hepatocelular.
    9. Síndrome hepatorrenal (tipo I o II) o creatinina en suero en la selección >LSN.
    10. Etiología conflictiva con la enfermedad hepática (por ejemplo, hepatitis C, hepatitis B activa, esteatosis hepática no alcohólica [EHNA], hepatopatía alcohólica [HPA], hepatitis autoinmune, colangitis esclerosante primaria o síndrome de Gilbert).
    11. Los sujetos que reciban medicamentos prohibidos a menos de 3 meses de la selección (visita 1) según la lista (a, b y c) provista en la sección 6.6.2.
    12. Tratamiento con cualquier agente en investigación a menos de 4 semanas de la visita 1 o a 5 períodos de la semivida del producto médico en investigación (lo que sea mayor).
    13. Historial de síndrome de QT largo.
    14. Evidencia de cualquiera de las siguientes anomalías en la conducción cardíaca durante el período de selección:
    • Un intervalo QTc de Fredericia de >450 milisegundos para los hombres y >470 milisegundos para las mujeres.
    • Un bloqueo atrioventricular de segundo o tercer grado tratado sin éxito con un marcapasos.
    15. Historial de cáncer en los 5 años anteriores, excepto cáncer de piel distinto al melanoma correctamente tratado, carcinoma in situ del cuello uterino, cáncer de próstata in situ, carcinoma ductal in situ de mama o cáncer superficial de vejiga en estadio 0.
    16. La aparición de cualquier infección aguda que requiera tratamiento con antibióticos sistémicos en las dos semanas anteriores a la visita de selección (visita 1) o infección por virus de inmunodeficiencia humana (VIH).
    17. Historial de trastorno de la médula ósea, incluyendo anemia aplásica o anemia marcada, definida como hemoglobina <10,0 g/dl (o 6,2 mmol/l).
    18. Cualquier afección que, en opinión del Investigador, suponga un riesgo o una contraindicación para la participación del sujeto en el estudio o que pueda interferir en los objetivos, la realización o la evaluación del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Primary:
    - the percent change from baseline to Week 24 (Visit 7) in serum GGT.
    Primary:
    - El cambio porcentual entre la visita basal y la semana 24 (visita 7) de la GGT en suero
    E.5.1.1Timepoint(s) of evaluation of this end point
    The percent change from baseline to Week 24 (Visit 7) in serum GGT.
    Serum GGT will be assessed during every treatment visit. (visit's 2-7)
    El cambio porcentual entre la visita basal y la semana 24 (visita 7) de la GGT en suero. Los niveles séricos de GGT se evaluarán en cada visita de tratamiento (visitas 2 a 7)
    E.5.2Secondary end point(s)
    - Absolute and percent change in serum GGT from baseline to each assessment.

    - Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to Weeks 12 and 24.

    - Absolute and percent change in serum levels of highsensitivity C-reactive protein (hsCRP) and fibrinogen from baseline to each
    assessment.

    - Absolute and percent change in serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and conjugated and total bilirubin, from baseline to each assessment.

    - Absolute and percent change in serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), conjugated and total bilirubin, and Cytokeratin-18 (CK-18), from baseline to each assessment.

    - Absolute and percent change in the Fibrosis-4 (FIB-4) and AST to Platelet Ratio Index (APRI) scores, from baseline to each assessment (FIB-4: age (years) x AST (IU/L)/(platelet count (109/L) x (ALT (IU/L)1/2, APRI: AST (IU/L)/ upper normal limit AST)x100/platelet count (10E9/L).

    - Absolute and percent change in liver stiffness as assessed by transient elastography (FibroScan or similar technology), from baseline to Week 24, in patients with values at baseline and Week 24.

    - Absolute and percent change in serum levels of collagen fragments indicative of collagen formation and degradation from baseline to Weeks 12 and 24.

    -Absolute and percent change in total bile acids from baseline to Week 12 and 24.
    - El cambio porcentual y absoluto de la GGT en suero entre la visita basal y cada evaluación.
    - El cambio absoluto de los resultados de fibrosis hepática mejorada (FHM) entre la visita basal y las semanas 12 y 24.
    - El cambio porcentual y absoluto de la FA en suero entre la visita basal y cada evaluación.
    - El cambio porcentual y absoluto de los niveles en suero de proteína C reactiva de alta sensibilidad (PCR-as) y fibrinógeno entre la visita basal y cada evaluación.
    - El cambio porcentual y absoluto de los niveles en suero de alanina aminotransferasa (ALT), aspartato aminotransferasa (AST), bilirrubina conjugada y total entre la visita basal y cada evaluación.
    - El cambio porcentual y absoluto de los resultados de fibrosis-4 (FIB-4) y del índice de la relación AST/plaquetas (APRI) entre la visita basal y cada evaluación (FIB-4: edad [años] x AST [IU/l]/(recuento plaquetario [109/l] x ALT [IU/l]1/2), APRI: (AST [IU/l]/límite normal superior AST)x100/recuento plaquetario [10E9/l].
    - El cambio porcentual y absoluto de la rigidez hepática evaluada mediante elastografía transitoria (FibroScan o tecnología similar) entre la visita basal y la semana 24 en pacientes con valores en la visita basal y la semana 24.
    - El cambio porcentual absoluto de los niveles en suero de fragmentos de colágeno, que indiquen la formación y degradación de colágeno entre la visita basal y las semanas 12 y 24.
    - El cambio porcentual y absoluto en el total de ácidos biliares entre la visita basal y las semanas 12 y 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints of the secondary endpoints are included within the secondary objective endpoints section E.5.2 (above)

    Most secondary assessments will be assessed from baseline to each visit however the ELF score and collagen fragments will be assessed from baseline to week 12 and week 24.
    The change in liver stiffness (FibroScan or similar technology) will be assessed from baseline to week 24.
    los puntos temporales de evaluación de los criterios de valoración secundarios se mencionan en la sección anterior
    La mayoría de las evaluaciones secundarias se evaluarán desde basal en cada visita. Sin embargo, el indicador de fibrosis hepática mejorada (FHM) y los fragmentos de colágeno se evaluarán desde la visita basal hasta la semana 12 y semana 24
    El cambio en la elastografía transitoria (FibroScan o tecnología similar) se evaluará desde basal hasta la semana 24
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Belgium
    Canada
    Germany
    Greece
    Israel
    Italy
    Spain
    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
    LVLS
    Última visita del Último paciente
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 102
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-08
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