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    Summary
    EudraCT Number:2017-004137-91
    Sponsor's Protocol Code Number:Gesida92016
    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:2017-12-13
    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 number2017-004137-91
    A.3Full title of the trial
    A single-arm, open-label, multicenter phase IV trial to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir alfa-namide as first-line treatment in naïve patients with HIV-1 infection with severe immunosuppression
    Estudio fase IV, abierto, multicéntrico, de un único brazo para evaluar la eficacia y seguridad de elvitegravir/cobicistat/emtricitabina/tenofovir alafenamida como tratamiento de primera línea en pacientes naïve con infección por VIH-1 con inmunosupresión severa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A single-arm, open-label, multicenter phase IV trial to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir alfa-namide as first-line treatment in naïve patients with HIV-1 infection with severe immunosuppression
    Estudio fase IV, abierto, multicéntrico, de un único brazo para evaluar la eficacia y seguridad de elvitegravir/cobicistat/emtricitabina/tenofovir alafenamida como tratamiento de primera línea en pacientes naïve con infección por VIH-1 con inmunosupresión severa
    A.3.2Name or abbreviated title of the trial where available
    GENIS
    GENIS
    A.4.1Sponsor's protocol code numberGesida92016
    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 SponsorFundacion SEIMC-GESIDA
    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 supportGilead
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación SEIMC-GESIDA
    B.5.2Functional name of contact pointMaria Yllescas
    B.5.3 Address:
    B.5.3.1Street AddressC/ Agustin de Betancourt nº 13, entreplanta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034915568025
    B.5.5Fax number0034915542283
    B.5.6E-mailmyllescas@f-sg.org
    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.2.1.1.1Trade name Genvoya
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENOFOVIR
    D.3.9.1CAS number 379270-37-8
    D.3.9.3Other descriptive nameTENOFOVIR ALAFENAMIDE FUMARATE
    D.3.9.4EV Substance CodeSUB178389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNELVITEGRAVIR
    D.3.9.1CAS number 697761-98-1
    D.3.9.3Other descriptive nameELVITEGRAVIR
    D.3.9.4EV Substance CodeSUB69759
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOBICISTAT
    D.3.9.1CAS number 1004316-88-4
    D.3.9.4EV Substance CodeSUB33760
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    AIDS
    SIDA
    E.1.1.1Medical condition in easily understood language
    AIDS
    SIDA
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001509
    E.1.2Term AIDS
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the therapeutic success based on the percentage of patients with an undetectable plasma viral load (HIV-1 RNA level <50 copies / mL) at 48 weeks, without therapeutic failure, according to the FDA Snapshot algorithm
    Describir el éxito terapéutico en base al porcentaje de pacientes con una carga viral plasmática indetectable (nivel de RNA del VIH-1 < 50 copias/mL) a las 48 semanas, sin fracaso terapéutico, de acuerdo al algoritmo Snapshot de la FDA
    E.2.2Secondary objectives of the trial
    • Evaluate the proportion of virological failures.
    • Evaluate the proportion of ART interruptions due to causes other than virological failure (non-virological failure).
    • Evaluate the time to virological suppression.
    • To evaluate the proportion of patients with virological failure, having previously been suppressed.
    • Evaluate the time to virological failure.
    • To evaluate the incidence of genotypic resistance in patients with virological failure.
    • Evaluate changes in viral load from the beginning of treatment.
    • Evaluate immune recovery based on changes in the CD4 + lymphocyte count.
    • Evaluate the safety profile of E / C / F / TAF under clinical practice conditions.
    • Evaluate the patient's satisfaction with the treatment.
    • Evaluate adherence to treatment during the study
    • Evaluar la proporción de fracasos virológicos.
    • Evaluar la proporción de interrupciones del TAR por causas diferentes al fracaso virológico (fracaso no virológico).
    • Evaluar el tiempo hasta la supresión virológica.
    • Evaluar la proporción de pacientes con fracaso virológico, habiendo estado previamente suprimidos.
    • Evaluar el tiempo hasta el fracaso virológico.
    • Evaluar la incidencia de resistencias genotípicas en pacientes con fracaso virológico.
    • Evaluar los cambios en la carga viral desde el inicio del tratamiento.
    • Evaluar la recuperación inmunológica en base a los cambios en el recuento de linfocitos CD4+.
    • Evaluar el perfil de seguridad de E/C/F/TAF en condiciones de práctica clínica.
    • Evaluar la satisfacción del paciente con el tratamiento.
    • Evaluar la adherencia al tratamiento durante el estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Have voluntarily granted informed consent before carrying out the specific procedures of the trial.
    • Adult patients (age ≥18 years) of both sexes.
    • Patients with HIV-1 infection with severe immunosuppression, defined by a concentration of CD4 + lymphocytes <200 cells / μL.
    • Patients who are going to be tested for genotypic resistance to inhibitors of intregrasa, emtricitabine or tenofovir (will be scheduled at the screening visit or selection / baseline visit in the event that both visits coincide).
    • Creatinine clearance ≥ 30 mL / min before the start of treatment.
    • ALT / AST levels not higher than five times normal levels, total bilirubin with normal values, neutrophils> 1000 cells / μL,> 50000 platelets / μL,> 85 g / L Hb, and serum amylase levels <1.5 times the upper normal limit before the start of treatment
    • Haber otorgado voluntariamente el consentimiento informado antes de la realización de los procedimientos específicos del ensayo.
    • Pacientes adultos (edad ≥ 18 años) de ambos sexos.
    • Pacientes con infección por VIH-1 con inmunosupresión severa, definida por una concentración de linfocitos CD4+ < 200 células/μL.
    • Pacientes a los que se les vaya a realizar un test de resistencias genotípicas a los inhibidores de la intregrasa, emtricitabina o tenofovir (se programará en la visita de selección o visita selección/basal en el caso de que coincidan ambas visitas).
    • Aclaramiento de creatinina ≥ 30 mL/min antes del inicio del tratamiento.
    • Niveles de ALT/AST no superiores a cinco veces los niveles normales, bilirrubina total con valores normales, neutrófilos>1000 cel/µL, >50000 plaquetas/ µL, >85 g/L Hb y niveles de amilasa sérica < de 1,5 veces el límite normal superior antes del inicio del tratamiento
    E.4Principal exclusion criteria
    • Patient receiving any concomitant treatment described as not allowed. Patient with documented intolerance or hypersensitivity to the study medication, or who has a contraindication to use it, according to the technical file.
    • Patient receiving therapies with interferon, interleukin 2, cytotoxic chemotherapy or immunosuppressants at the baseline visit.
    • Patients with neoplasms, with the exception of skin carcinoma (excluding melanoma and hawthorn) and anal cancer in situ (stage 0).
    • Patient with any medical or psychological, sociological or geographical alteration, toxic habit (drugs, alcohol) that, in the opinion of the investigator, could interfere in the compliance of the study by the patient. These conditions will be discussed with the patient before their inclusion in the trial.
    • Patients with any medical or psychological alteration that, in the opinion of the researcher, could compromise the patient's ability to understand and complement the questionnaires and scales used in the study.
    • Patient in treatment with any investigational drug / product or who is participating in a clinical trial using an investigational product, with the exception of studies in which the study treatment was completed more than 12 weeks ago.
    • Pregnant women, in breastfeeding period or with a positive pregnancy test in the selection period; women of childbearing age and sexually active who are not willing to use an adequate contraceptive method (such as oral contraceptives, intrauterine device or contraceptive barrier method together with spermicide or surgical sterilization) during the study and up to 3 months after the administration of the last dose of the study treatment. Women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months.
    • Patients with severe hepatic impairment (Child-Pugh Class C).

















    Sugerir
    • Paciente que reciba algún tratamiento concomitante descrito como no permitido. Paciente con intolerancia o hipersensibilidad documentada al medicamento de estudio, o que presente alguna contraindicación para utilizarlo, atendiendo a ficha técnica.
    • Paciente que esté recibiendo terapias con interferón, interleucina 2, quimioterapia citotóxica o inmunosupresores en la visita basal.
    • Pacientes con neoplasias, a excepción de carcinoma de piel (excluyendo el melanoma y espino celular) y el cáncer de ano in situ (estadio 0).
    • Paciente con cualquier alteración médica o psicológica, sociológica o geográfica, hábito tóxico (drogas, alcohol) que, a criterio del investigador, pueda interferir en el cumplimiento del estudio por parte del paciente. Estas condiciones serán comentadas con el paciente antes de su inclusión en el ensayo.
    • Pacientes con cualquier alteración médica o psicológica que, a criterio del investigador, pueda comprometer la capacidad del paciente para comprender y complementar los cuestionarios y escalas utilizadas en el estudio.
    • Paciente en tratamiento con cualquier medicamento/producto en investigación o que se encuentre participando en un ensayo clínico que utilice un producto en investigación, con la excepción de estudios en los que el tratamiento de estudio haya finalizado hace más de 12 semanas.
    • Mujeres embarazadas, en periodo de lactancia o con un test de embarazo positivo en el periodo de selección; mujeres en edad fértil y sexualmente activas que no estén dispuestas a utilizar un método anticonceptivo adecuado (como anticonceptivos orales, dispositivo intrauterino o método de barrera anticonceptivo junto con espermicida o esterilización quirúrgica) durante el estudio y hasta 3 meses después de la administración de la última dosis del tratamiento de estudio. Se definen mujeres en edad fértil como aquellas mujeres que no hayan sido sometidas a procedimientos de infertilidad permanente o que sean amenorreicas desde hace menos de 12 meses.
    • Pacientes con insuficiencia hepática grave (Clase C de Child-Pugh).
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with plasma viral load of HIV-1 RNA <50 copies / mL at 48 weeks, without therapeutic failure, according to the FDA Snapshot algorithm (Annex 3) in the population "intention to treat modified" .
    Proporción de pacientes con una carga viral plasmática de ARN del VIH-1 <50 copias/mL a las 48 semanas, sin fracaso terapéutico, de acuerdo al algoritmo Snapshot de la FDA (Anexo 3) en la población "por intención de tratar modificada".
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Week 48
    - Semana 48
    E.5.2Secondary end point(s)
    - Proportion of patients with virological failure, including patients with plasma HIV-1 RNA load ≥50 copies / mL in the last measurement while the patient receives the treatment in the window period, patients who interrupt the treatment prematurely by lack / loss of efficacy in which the last viral load was ≥50 copies / mL or in which antiretroviral treatment is modified before 48 weeks.
    - Proportion of patients who interrupt the treatment prematurely due to absence or loss of efficacy.
    - Proportion of patients who interrupt treatment prematurely for other reasons (other than an adverse event, death or loss of efficacy) and whose last viral load at the time of quitting was ≥50 copies / mL.
    - Proportion of patients in whom antiretroviral treatment is modified before the end of the study.
    - Proportion of patients who interrupt treatment prematurely for safety reasons, including adverse events and diseases associated with AIDS
    - Proportion of patients who interrupt treatment prematurely for other reasons (withdrawal of informed consent, loss of follow-up, etc.) and whose last viral load at the time of abandonment was ≥50 copies / mL.
    - Proportion of patients with absence / loss of virological data in the window of week 48 that continue in the study at 48 weeks.
    - Time to virological suppression (viral load <50 copies / mL)
    - Proportion of patients with virological failure defined by protocol as a viral load> 1000 copies / mL at week 24 or 2 consecutive viral loads> 50 copies / mL (at least 2 weeks apart) while receiving ART, having previously been suppressed
    - Time to virological failure (viral load ≥50 copies / mL).
    - Incidence of genotypic resistances in patients with virological failure, and description of them.
    - Changes in viral load (plasma concentration of HIV RNA) from the start of treatment to weeks 4, 8, 12, 24, 36, and 48.
    - Change in the count of CD4 + lymphocytes from the start of treatment until week 48.
    - Proportion of patients who have a CD4 + count> 200 cells / μL at 48 weeks.
    - Average time to reach a CD4 + lymphocyte count> 200 cells / μL.
    - Rate of failure due to toxicity, defined as any discontinuation not due to virological failure, and time to failure due to toxicity.
    - Incidence and severity of adverse clinical and laboratory events, classified according to the criteria of the Division of AIDS
    - Incidence of events related to AIDS, distinguishing between those detected during the first month with the study treatment and those that take place during the rest of the study.
    - Incidence of serious events not related to AIDS: cardiovascular disease, chronic kidney disease, liver failure, neoplasms not caused by AIDS unless they were present at the beginning of treatment, whether squamous cell skin cancer or non-traumatic fractures.
    - Incidence of manifestations of SIRI.
    - Changes in total fasting glucose, total cholesterol, HDL and LDL levels, total cholesterol / HDL ratio and triglycerides during the study period.
    - Changes in the glomerular filtration rate according to the Cockcroft-Gault (GC) formulas
    - Percentage of deaths related or not with AIDS.
    - Satisfaction of the patient with the treatment, based on the score of the satisfaction scale with the antiretroviral treatment (ESTAR)
    - Adherence to treatment during the study based on the count of medication returned at all follow-up visits
    - Proporción de pacientes con fracaso virológico, incluyendo los pacientes con una carga viral plasmática de ARN del VIH-1 ≥50 copias/mL en la última medición mientras el paciente recibe el tratamiento en el periodo ventana, los pacientes que interrumpen el tratamiento prematuramente por falta/pérdida de eficacia en los que la última carga viral fue de ≥50 copias/mL o en los que se modifica el tratamiento antirretroviral antes de las 48 semanas.
    - Proporción de pacientes que interrumpen el tratamiento prematuramente debido a ausencia o pérdida de eficacia.
    - Proporción de pacientes que interrumpen el tratamiento prematuramente por otros motivos (distintos de un acontecimiento adverso, muerte o pérdida de eficacia) y cuya última carga viral en el momento del abandono fuera de ≥50 copias/mL.
    - Proporción de pacientes en los que se modifica el tratamiento antirretroviral antes de la finalización del estudio
    - Proporción de pacientes que interrumpen el tratamiento prematuramente por motivos de seguridad, incluyendo acontecimientos adversos y enfermedades asociados a SIDA
    - Proporción de pacientes que interrumpen el tratamiento prematuramente por otros motivos (retirada del consentimiento informado, pérdida de seguimiento, etc.) y cuya última carga viral en el momento del abandono fuera de ≥50 copias/mL.
    - Proporción de pacientes con ausencia/pérdida de datos virológicos en la ventana de la semana 48 que continúan en el estudio a las 48 semanas.
    - Tiempo hasta la supresión virológica (carga viral <50 copias/mL)
    - Proporción de pacientes con fracaso virológico definido por protocolo como una carga viral >1000 copias/mL a la semana 24 o 2 cargas virales consecutivas >50 copias/mL (con al menos 2 semanas de separación) mientras reciben el TAR, habiendo estado previamente suprimidos.
    - Tiempo hasta el fracaso virológico (carga viral ≥50 copias/mL).
    - Incidencia de resistencias genotípicas en pacientes con fracaso virológico, y descripción de las mismas.
    - Cambios en la carga viral (concentración plasmática del ARN del VIH) desde el inicio del tratamiento a las semanas 4, 8, 12, 24, 36, y 48.
    - Cambio en el recuento de linfocitos CD4+ desde el inicio del tratamiento hasta la semana 48.
    - Proporción de pacientes que tienen un recuento de CD4+ > 200 cél/μL a las 48 semanas.
    - Tiempo medio hasta alcanzar un recuento de linfocitos CD4+ > 200 cél/μL.
    - Tasa de fracaso por toxicidad, definido como cualquier discontinuación no debida a fracaso virológico, y tiempo hasta el fracaso por toxicidad.
    - Incidencia y gravedad de acontecimientos adversos clínicos y de laboratorio, clasificados de acuerdo a los criterios de la División del SIDA
    - Incidencia de acontecimientos relacionados con el SIDA, distinguiendo entre aquellos detectados durante el primer mes con el tratamiento de estudio y los que tienen lugar durante el resto del estudio.
    - Incidencia de acontecimientos graves no relacionados con el SIDA: enfermedad cardiovascular, enfermedad renal crónica, fallo hepático, neoplasias no ocasionados por el SIDA excepto que estuvieran presentes al inicio del tratamiento, bien sea cáncer de piel escamocelular o fracturas no traumáticas.
    - Incidencia de manifestaciones de SIRI
    - Cambios en la media de glucosa total en ayuno, niveles de colesterol total, HDL y LDL, ratio colesterol total/HDL y triglicéridos durante el periodo de estudio.
    - Cambios en la tasa de filtración glomerular según las fórmulas de Cockcroft-Gault (GC)
    - Porcentaje de muertes relacionadas o no con el SIDA.
    - Satisfacción del paciente con el tratamiento, en base a la puntuación de la escala de satisfacción con el tratamiento antirretroviral (ESTAR)
    - Adherencia al tratamiento durante el estudio en base al recuento de la medicación devuelta en todas las visitas de seguimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 4, 8, 12, 24, 36 and 48
    Semanas 4, 8, 12, 24, 36 y 48
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Brazo único
    Single arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned6
    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
    Last patient 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 months1
    E.8.9.1In the Member State concerned days
    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: 50
    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 state50
    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)
    Routine medical practice
    Práctica clínica habitual
    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 Decision2018-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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