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    Summary
    EudraCT Number:2012-002488-88
    Sponsor's Protocol Code Number:GS-US-321-0105
    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:2013-05-20
    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 number2012-002488-88
    A.3Full title of the trial
    A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in Subjects with Advanced Liver Fibrosis but not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
    Ensayo en fase 2b, de determinación de dosis, aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de GS-6624, un anticuerpo monoclonal contra la proteína tipo lisil oxidasa 2 (LOXL2) , en pacientes con fibrosis hepática avanzada pero no cirrosis secundaria a esteatohepatitis no alcohólica (EHNA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigational study to assess the safety and efficacy of a new investigational drug in subjects with liver fibrosis but no liver cirrhosis secondary to non-alcoholic steatohepatitis (NASH)
    Estudio para evaluar la seguridad y eficacia de un nuevo medicamento en investigación en pacientes con fibrosis hepática pero no cirrosis secundaria a esteatohepatitis no-acohólica (EHNA)
    A.4.1Sponsor's protocol code numberGS-US-321-0105
    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 SponsorGilead Sciences 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 supportGilead Sciences Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences Inc
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address333 Lakeside Drive
    B.5.3.2Town/ cityFoster City
    B.5.3.3Post codeCA 94404
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650574 3000
    B.5.5Fax number+1650578 9264
    B.5.6E-mailclinical.trials@gilead.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 GS-6624
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGS-6624
    D.3.9.2Current sponsor codeGS-6624
    D.3.9.4EV Substance CodeSUB33243
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGS-6624
    D.3.9.2Current sponsor codeGS-6624
    D.3.9.4EV Substance CodeSUB33243
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Liver Fibrosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
    Fibrosis hepática avanzada secundaria a esteatohepatitis no alcohólica (EHNA)
    E.1.1.1Medical condition in easily understood language
    Liver Fibrosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
    Fibrosis hepática secundaria a esteatohepatitis no alcohólica (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 14.1
    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 evaluate whether GS-6624 is effective at preventing the progression of liver fibrosis in subjects with NASH.
    Evaluar si GS-6624 es eficaz para prevenir la progresión de la fibrosis hepática en pacientes con EHNA.
    E.2.2Secondary objectives of the trial
    To assess the safety of GS-6624 in subjects with NASH;
    To assess the immunogenicity of GS-6624 in this population;
    To assess whether baseline LOXL2 levels are predictive of response to GS-6624 therapy (active arms) and/or prognostic for disease progression (placebo arm);
    To compare different efficacy assessment tools in this population;
    To determine whether non-invasive measures of fibrosis can predict regression of fibrosis and prevention of cirrhosis in this population.
    Evaluar la seguridad de GS-6624 en pacientes con EHNA;
    Evaluar la inmunogenicidad de GS-6624 en esta población.
    Evaluar si las concentraciones basales de LOXL2 son predictivas de la respuesta al tratamiento con GS-6624 (grupos de tratamiento activo) y/o pronósticas de progresión de la enfermedad (grupo placebo).
    Comparar distintos instrumentos de evaluación de la eficacia en esta población.
    Determinar si medidas no invasivas de la fibrosis pueden predecir la regresión de la fibrosis y la prevención de la cirrosis en esta población.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    MRE Substudy
    The Magnetic Resonance Elastography (MRE) Substudy will consist of approximately 50 subjects from selected investigative sites with the ability to perform MRE. Subjects will undergo a liver stiffness assessment by MRE at Baseline Visit, Week 48 and the End of Treatment Visit (Week 96).

    Impedance Ultrasonography Substudy
    The Impedance Ultrasonography Substudy will consist of approximately 50 subjects from selected investigative sites with the ability to perform impedance ultrasonography (such as Fibroscan). Subjects will undergo a liver stiffness assessment by impedance ultrasonography at Baseline Visit, Week 48 and the End of Treatment Visit (Week 96).
    Como parte de este estudio se realizarán dos subestudios exploratorios en centros que cuenten con la capacidad pertinente:

    - En el subestudio de elastografía por resonancia magnética (ERM) participarán unos 50 pacientes procedentes de centros de investigación seleccionados con capacidad para realizar esta prueba. Estos pacientes se someterán a una evaluación de la rigidez hepática mediante ERM en la visita basal, en la semana 48 y en la visita de final del tratamiento (semana 96).

    - En el subestudio de ecografía de impedancia participarán unos 50 pacientes procedentes de centros de investigación seleccionados con capacidad para realizar esta prueba (como Fibroscan). Estos pacientes se someterán a una evaluación de la rigidez hepática mediante ecografía de impedancia en la visita basal, en la semana 48 y en la visita de final del tratamiento (semana 96).
    E.3Principal inclusion criteria
    1. Males and females 18 - 65 years of age;
    2. Be willing and able to provide written informed consent;
    3. Have chronic liver disease due to NASH defined as macrovesicular steatosis involving >5% of hepatocytes on a liver biopsy with associated lobular inflammation;
    4. Stage 3-4 fibrosis by Ishak score on a liver biopsy. If the subject is deemed ineligible for this study, the liver biopsy, if performed according to protocol specifications and is within 3 months of the screening visit, may be used to determine eligibility for the GS-US-321-0106 study (another Gilead
    Sciences NASH study that also must be IRB/EC approved at participating centers);
    5. Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease;
    6. Must be willing and able to comply with all study requirements;
    7. Must have AST and ALT ? 10 x clULN (refer to the central laboratory manual for normal ranges);
    8. Must have serum creatinine < 2.0 mg/dL;
    9. Female subjects of childbearing potential must have a negative serum pregnancy test prior to starting study treatment. For the purposes of this study, a female subject of child-bearing potential is a woman who has not had a hysterectomy, bilateral oophorectomy, or medically-documented ovarian failure. Women ? 50 years of age with amenorrhea of any duration will be considered to be of childbearing potential;
    10. All female subjects who are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the study period and for 90 days following the last dose of study drug. If females utilize hormonal agents as one of their contraceptive methods, the same hormonal method must have been used for at least 1 month before study dosing. Females on hormonal methods must also utilize a barrier method as another form of contraception (See Section 7.11.2);
    11. Lactating females must agree to discontinue nursing before starting study treatment.
    12. Male subjects, if not vasectomized, are required to use barrier contraception (condom plus spermicide) during heterosexual intercourse from the screening through the study completion
    and for 90 days following the last dose of study drug.
    1.Varones y mujeres de 18-65 años de edad.
    2.Disposición y capacidad para otorgar el consentimiento informado por escrito.
    3.Tener hepatopatía crónica debida a EHNA definida como esteatosis macrovesicular con >5 % de hepatocitos en una biopsia hepática acompañada de inflamación lobular;
    4.Fibrosis en estadio 3-4 de Ishak en una biopsia hepática. Si se considera que el paciente no es apto para el estudio, la biopsia hepática, en caso de que se practique según las especificaciones del protocolo y en los 3 meses anteriores a la visita de selección, podrá utilizarse para determinar si es apto para el estudio GS-US-321-0106 (otro de los estudios de Gilead Sciences que forman parte del programa sobre la EHNA que también debe ser aprobado por el CEIC de los centros participantes);
    5.Exclusión de otras causas de hepatopatía, como hepatitis viral y hepatopatía alcohólica.
    6.Disposición y capacidad para cumplir todos los requisitos del estudio.
    7.AST y ALT ? 10 veces el LSNlc (véanse los intervalos normales en el manual del laboratorio central).
    8.Creatinina sérica < 2,0 mg/dl.
    9.Las mujeres en edad fértil deberán dar negativo en una prueba de embarazo en suero realizada antes del comienzo del tratamiento del estudio. A efectos de este estudio, una mujer en edad fértil es aquella que no se ha sometido a una histerectomía ni ovariectomía bilateral y que no tiene insuficiencia ovárica documentada médicamente. Se considerará en edad fértil a las mujeres de edad ? 50 años con amenorrea de cualquier duración.
    10.Todas las mujeres en edad fértil deberán comprometerse a utilizar un método anticonceptivo muy eficaz cuando mantengan relaciones heterosexuales desde la visita de selección, durante todo el período del estudio y hasta 90 días después de la última dosis del fármaco del estudio. En el caso de mujeres que utilicen fármacos hormonales como uno de los métodos anticonceptivos, deberá haberse utilizado el mismo método hormonal durante al menos un mes antes de la administración de la medicación del estudio. Las mujeres que estén empleando métodos hormonales deberán utilizar un método de barrera como otro método anticonceptivo (véase la sección 7.11.2).
    11.Las mujeres lactantes deberán comprometerse a interrumpir la lactancia materna antes del inicio del tratamiento del estudio.
    12.Los varones, en caso de no estar vasectomizados, deberán comprometerse a utilizar un método anticonceptivo de barrera (preservativo con espermicida) cuando mantengan relaciones heterosexuales desde la visita de selección, durante todo el período del estudio y hasta 90 días después de la última dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    1. Pregnant or breast feeding;
    2. Cirrhosis of the liver;
    3. Any history of hepatic decompensation, including ascites, hepatic encephalopathy, variceal bleeding;
    4. Weight reduction surgery in the past 5 years;
    5. HCV RNA positive;
    6. HBsAg positive;
    7. Alcohol consumption greater than 21oz/week for males or 14oz/week for females (1oz/25mL of alcohol is present in 1 12oz/300mL beer, 1 4oz/125mL glass of wine, and a 1 oz/25mL measure of 40% proof alcohol)
    8. Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at screening. Subjects on stable methadone or buprenorphine maintenance treatment for at least 6 months
    prior to screening may be included in the study. Subjects with a positive urine drug screen due to prescription opioid-based medication are eligible if the prescription and diagnosis are reviewed and approved by the investigator;
    9. Clinically significant cardiac disease;
    10. History of malignancy, other than non-melanomatous skin cancer, within 5 years prior to screening;
    11. Major surgical procedure within 30 days prior to screening or the presence of an open wound;
    12. Known hypersensitivity to the investigation product or any of its formulation excipients;
    13. History of bleeding diathesis within 6 months of screening;
    14. Unavailable for follow-up assessment or concern for subject?s compliance with the protocol procedures;
    15. Participation in an investigational trial of a drug or device within 30 days prior to screening;
    16. Any other condition that in the opinion of the investigator renders the subject a poor risk for inclusion into the study.
    1.Embarazo o lactancia.
    2.Cirrosis hepática;
    3.Antecedentes de descompensación hepática, tales como ascitis, encefalopatía hepática, hemorragia por varices;
    4.Cirugía de adelgazamiento en los 5 años precedentes.
    5.ARN del VHC positivo.
    6.HBsAg positivo.
    7.Consumo de alcohol de más de 600 gramos/semana en varones y 400 gramos/semana en mujeres (hay 28 grs/25 ml de alcohol en una cerveza de 336 grs/300mL, en un vaso de vino de 115 grs/125 ml y en una unidad de alcohol con una graduación de 40 % de 28 grs/125 ml
    8.Análisis toxicológico en orina positivo para anfetaminas, cocaína u opiáceos (por ejemplo, heroína o morfina) en el momento de selección. Podrán participar en el estudio los pacientes en tratamiento de mantenimiento estable con metadona o buprenorfina durante al menos 6 meses antes de la selección. Los pacientes con un análisis toxicológico en orina positivo para medicamentos de venta con receta a base de opiáceos podrán participar en caso de que la prescripción y el diagnóstico sean revisados y aprobados por el investigador.
    9.Cardiopatía clínicamente importante.
    10.Antecedentes de cáncer, aparte de un cáncer de piel distinto del melanoma, en los 5 años previos a la selección.
    11.Intervención de cirugía mayor en los 30 días previos a la selección o presencia de una herida abierta.
    12.Hipersensibilidad conocida al producto en investigación o a cualquiera de los excipientes de la formulación.
    13.Antecedentes de diátesis hemorrágica en los 6 meses previos a la selección.
    14.Indisponibilidad para la evaluación de seguimiento o preocupación por el cumplimiento de los procedimientos del protocolo por parte del paciente.
    15.Participación en un estudio de investigación de un fármaco o un producto sanitario en los 30 días previos a la selección.
    16.Cualquier otra situación que, en opinión del investigador, haga que el paciente corra un riesgo elevado en caso de participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be:
    1. Prevention of progression of fibrosis as assessed by change from baseline in morphometric quantitative collagen on liver biopsy;
    El criterio de valoración principal será:
    1.Prevención de la progresión de la fibrosis, evaluada mediante la variación con respecto al momento basal del colágeno cuantitativo morfométrico en la biopsia hepática.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will complete the 96 week treatment course with blinded study medication and will undergo repeat HbA1c liver biopsy at weeks 48 and 96 to assess the primary endpoint.
    Los pacientes completarán el ciclo de tratamiento de 96 semanas con la medicación enmascarada del estudio y se someterán a un nuevo análisis de HbA1c y a una nueva biopsia hepática en las semanas 48 y 96 para evaluar el criterio de valorazión principal
    E.5.2Secondary end point(s)
    Exploratory efficacy endpoints will include:
    1. Prevention of progression to cirrhosis as assessed by change from baseline in Ishak fibrosis stage on liver biopsy.
    2. Prevention of progression of liver disease as assessed by change from baseline in the MELD score;
    3. Reduction in the amount of activated hepatic stellate cells as assessed by change from baseline in ?-smooth muscle actin on liver biopsy;
    4. Reduction in fibrosis disease activity as assessed by change from baseline in serum LOXL2 levels;
    5. Change from baseline in non-invasive markers of fibrosis including the ELF? test score and
    FibroSURE/FibroMAX/FibroTest;
    6. Number of clinical events of hepatic decompensation occurring in each arm (including variceal bleeding, ascites, hepatic encephalopathy, development of hepatocellular carcinoma or
    death);
    7. Change from baseline on liver enzymes: ALT, AST, bilirubin, GGT and alkaline phosphatase;
    8. Change from baseline in HOMA-IR.

    Substudy endpoints will include:
    1. Reduction in liver fibrosis as assessed by change from baseline in liver stiffness by MRE;
    2. Reduction in liver fibrosis as assessed by change from baseline in liver stiffness by impedance ultrasonography.

    Subgroup analyses will be conducted to assess:
    ? The effect of weight loss on the efficacy parameters. Subjects who lose at least 5% of their body weight will be compared to subjects who fail to lose this much weight across all of the above efficacy parameters.
    Los criterios de valoración exploratorios de la eficacia serán:
    1.Prevención de la progresión a cirrosis, evaluada mediante la variación con respecto al momento basal del estadio de fibrosis de Ishac en la biopsia hepática.
    2.Prevención de la progresión de la hepatopatía, evaluada mediante la variación con respecto al momento basal de la puntuación MELD.
    3.Reducción de la cantidad de células estrelladas hepáticas activadas evaluada mediante la variación con respecto al momento basal de la ?-actina del músculo liso en la biopsia hepática.
    4.Reducción de la actividad de la enfermedad en cuanto a fibrosis, evaluada mediante la variación con respecto al momento basal de la concentración sérica de LOXL2.
    5.Variación con respecto al momento basal de los marcadores no invasivos de fibrosis, entre ellos la prueba ELFTM y el FibroSURE/FibroMAX/FibroTest.
    6.Número de episodios clínicos de descompensación hepática que se produzcan en cada grupo (entre ellos, hemorragia por varices, ascitis, encefalopatía hepática, desarrollo de un carcinoma hepatocelular o muerte).
    7.Variación con respecto al momento basal de las enzimas hepáticas: ALT, AST, bilirrubina, GGT y fosfatasa alcalina.
    8.Variación con respecto al momento basal del índice HOMA-IR.
    Los criterios de valoración de los subestudios serán los siguientes:
    1.Reducción de la fibrosis hepática evaluada mediante la variación con respecto al momento basal de la rigidez hepática mediante ERM.
    2.Reducción de la fibrosis hepática evaluada mediante la variación con respecto al momento basal de la rigidez hepática mediante ecografía de impedancia.
    Se realizarán análisis de subgrupos para evaluar:
    El efecto de la pérdida de peso sobre los parámetros de eficacia. Se comparará a los pacientes que pierdan al menos el 5 % de su peso con los que no logren perder este peso en todos los parámetros de eficacia anteriores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoints:
    Subjects will complete the 96 week treatment course with blinded study medication and will undergo repeat HbA1c liver biopsy and HVPG measurement at weeks 48 and 96. Repeat non-invasive markers of fibrosis and fibrogenesis will be assessed at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96. Chemistry and hematology will be assessed every 4 weeks, allowing for the MELD score to be calculated at 4 week intervals. The HOMA-IR will be calculated at baseline, Week 48 and Week 96.

    Subjects will undergo a liver stiffness assessment by MRE at the Baseline Visit, Week 48 and the End of Treatment Visit (Week 96).

    Subjects will undergo a liver stiffness assessment by impedance ultrasonography at the Baseline Visit, Week 48 and the End of Treatment Visit (Week 96).
    Los pacientes completarán el ciclo de tratamiento de 96 semanas con la medicación enmascarada del estudio y se someterán a un nuevo análisis de HbA1c y a una nueva biopsia hepática en las semanas 48 y 96.Se evaluarán los marcadores no invasivos de fibrosis y fibrogenia en las semanas 4, 8, 12, 24, 36, 48, 60, 72, 84 y 96.Los análisis de bioquímica y hematología se harán cada 4 semanas,lo cual permitirá calcular la puntuación MELD en cada visita.A partir de las pruebas analíticas obtenidas en las semanas 48 y 96 se calculará el índice HOMA-IR.Los sujetos se someterá a una evaluación hepática por ERM en la visita basal, semana 48 y al final del tto (sem 96).Los sujetos se someterán a una evaluación de la hepática mediante ecografía en la visita basal, sem 48 y lal final del tto (sem 96).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Canada
    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
    Last Subject Last visit
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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: 225
    F.1.3Elderly (>=65 years) No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 225
    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)
    Gilead will provide no post trial treatment. Treatment following the trial will not be be the standard offered to someone with their underlying disease and will be determined by the treating physician.
    Gilead no proporcionará tratamiento tras el ensayo. El tratamiento después del ensayo no será el tratamiento estándar ofrecido a alguien con enfermedad subyacente y se determinará por el médico que le trate.
    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 Decision2013-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-29
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