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    Summary
    EudraCT Number:2015-002710-74
    Sponsor's Protocol Code Number:GS-US-292-1824
    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:2015-10-05
    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 number2015-002710-74
    A.3Full title of the trial
    A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adult Subjects Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I
    Estudio piloto de fase 3b abierto para evaluar el cambio a la combinación de dosis fijas (CDF) elvitegravir/cobicistat/emtricitabina/tenofovir alafenamida (E/C/F/TAF) en sujetos adultos infectados por el VIH-1 con supresión virológica que tienen la mutación de resistencia a ITIAN archivada aislada M184V/M184I
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the safety, tolerability and how well viral suppression is maintained of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) in HIV-1 infected subjects who are virologically suppressed and harbor the archived isolated NRTI resistance mutation M184V/M184I.
    Estudio para probar la seguridad, tolerabilidad y mantenimiento de la supresión viral al cambiar a una combinación de dosis fija (CDF) de elvitegravir / cobicistat / emtricitabina / tenofovir alafenamide (E/C/F/TAF) en sujetos infectados por VIH-1 que estén virológicamente suprimidosportadores de la mutación aislada y archivada M184V/M184I de resistencia a los ITIAN
    A.4.1Sponsor's protocol code numberGS-US-292-1824
    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 International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441223897284
    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 E/C/F/TAF 150mg/150mg/200mg/10mg
    D.3.4Pharmaceutical form Film-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 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.3.8 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 alafenamide
    D.3.9.1CAS number 379270-37-8
    D.3.9.3Other descriptive nameTENOFOVIR ALAFENAMIDE
    D.3.9.4EV Substance CodeSUB121761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Human Immunodeficiency Virus (HIV-1) Infection
    Infección por el Virus de la Inmunodeficiencia Humana (VIH-1)
    E.1.1.1Medical condition in easily understood language
    Human Immunodeficiency Virus (HIV-1) Infection
    Infección por el Virus de la Inmunodeficiencia Humana (VIH-1)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    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 evaluate the efficacy of E/C/F/TAF fixed dose combination (FDC) after switching from a stable regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent in maintaining HIV-1 RNA < 50 copies/mL at Week 12 (using pure virologic response) in subjects harboring the archived NRTI resistance mutation M184V and/or M184I in HIV-1 reverse transcriptase
    Evaluar la eficacia de cambiar a una CDF E/C/F/TAF en comparación con seguir con una pauta formada por FTC/TDF o ABC/3TC más un tercer antirretroviral para mantener un ARN del VIH-1 <50 copias/ml en la semana 12 (utilizando la respuesta virológica pura) en sujetos adultos portadores de la mutación aislada y archivada M184V y/o M184I de resistencia a los ITIAN en la transcriptasa inversa del VIH-1.
    E.2.2Secondary objectives of the trial
    - To determine the safety and tolerability of E/C/F/TAF FDC in subjects switching from 2 NRTI plus third antiretroviral agent regimens
    - To evaluate the development of new resistance mutations in subjects who develop virologic failure after switching to E/C/F/TAF FDC
    - To determine the durability of efficacy at Weeks 24 and 48 in maintaining HIV-1 RNA < 50 copies/mL using pure virologic response (PVR)
    - Determinar la seguridad y tolerabilidad de la CDF de E/C/F/TAF en sujetos que cambian de una pauta de dos ITIAN más un tercer antirretroviral.
    - Evaluar el desarrollo de nuevas mutaciones de resistencia en sujetos que experimentan fracaso virológico después de cambiar a la CDF de E/C/F/TAF.
    - Determinar la duración de la eficacia en las semanas 24 y 48 reflejada en el mantenimiento de un ARN del VIH-1 <50 copias/ml utilizando la respuesta virológica pura (RVP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
    2) Age ? 18 years
    3) Documented historical genotype report showing M184V and/or M184I (mixtures are acceptable) in reverse transcriptase. Subjects must not have any primary INSTI or primary PI resistance mutations present on historical genotype; NNRTI mutations are allowed. Proviral DNA test must not have additional exclusion resistance mutations against PIs, NRTIs and INSTIs.
    - Part 1 (first 50 subjects): Historical genotype report must show M184V and/or M184I in reverse transcriptase WITHOUT any other NRTI resistance mutation (including thymidine analogue-associated mutations (TAMs) [TAMs are: M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E/N/R], K65R, T69 insertion and Q151M mutation complex [A62V, V75I, F77L, F116Y, Q151M].
    - Part 2 (after the interim efficacy review ? 50 subjects): Historical genotype report must show M184V and/or M184I in reverse transcriptase WITH or WITHOUT one or two thymidine analogue-associated mutations (TAMs) [TAMs are: M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E/N/R]. Evidence of K65R, T69 insertion and/or Q151M mutation complex [A62V, V75I, F77L, F116Y, Q151M] will not be eligible.
    4) Currently receiving an antiretroviral regimen consisting of FTC/TDF or ABC/3TC in combination with one third antiretroviral agent for ? 6 consecutive months preceding the Screening Visit.
    5) Documented plasma HIV-1 RNA levels < 50 copies/mL for ? 6 months preceding the screening visit (measured at least twice using the same assay).
    6) Plasma HIV-1 RNA levels < 50 copies/mL at Screening Visit
    7) Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
    8) Estimated GFR ? 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
    9) Hepatic transaminases (AST and ALT) ? 5 × upper limit of normal (ULN)
    10) Total bilirubin ? 1.5 mg/dL, or normal direct bilirubin (subjects with documented Gilbert´s syndrome or with atazanavir-associated hyperbilirubinemia may have total bilirubin up to 5 × ULN)
    11) Adequate hematologic function (absolute neutrophil count ? 1,000/mm3; platelets ? 50,000/mm3; hemoglobin ? 8.5 g/dL)
    12) A female subject is eligible to enter the study if it is confirmed that she is:
    a) Not pregnant confirmed by a negative serum pregnancy test, which is required for female subjects (unless permanently sterile or greater than two years post-menopausal)
    b) Of non-childbearing potential (e.g., women who have had a hysterectomy, have had both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 54 years of age with cessation (for ?12 months) of previously occurring menses)
    c) Female subjects who have stopped menstruating for ? 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory Reference range.
    d) Of childbearing potential and agrees to utilize the protocol specified method of contraception or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following
    discontinuation of study drugs
    e) Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
    13) Male subjects must agree to use the protocol specified method(s) of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from screening throughout the study period and for 30 days following the last study drug dose.
    a) Male subjects must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose.
    1) El sujeto es capaz de comprender y firmar el documento de consentimiento informado, que deberá obtenerse antes del inicio de los procedimientos del estudio.
    2) Edad ?18 años.
    3) Informe de genotipificación histórico documentado que muestre M184V/M184I (se aceptan las mezclas) en la transcriptasa inversa. Los sujetos no deben presentar mutaciones de resistencia primarias a los ITCI ni a los IP en el genotipo histórico; se admiten las mutaciones de resistencia a los ITINN. El análisis de ADN proviral no debe mostrar otras mutaciones de resistencia excluyentes contra IP, ITIAN o ITCI.
    ? Parte 1 (primeros 50 sujetos): el informe de genotipificación histórico debe mostrar M184V/M184I en transcriptasa inversa SIN ninguna otra mutación de resistencia a ITIAN (incluidas las mutaciones asociadas a los análogos de la timidina (MAT) [las MAT son: M41L, D67N, K70R, L210W, T215Y/F y K219Q/E/N/R], K65R, inserción de T69 y complejo mutacional Q151M [A62V, V75I, F77L, F116Y, Q151M]).
    ? Parte 2 (después de la revisión intermedia de la eficacia; 50 sujetos): el informe de genotipificación histórico debe mostrar M184V/M184I en transcriptasa inversa CON o SIN una o dos mutaciones asociadas a los análogos de la timidina (MAT) [las MAT son: M41L, D67N, K70R, L210W, T215Y/F y K219Q/E/N/R]. La presencia de K65R, inserción de T69 y/o complejo mutacional Q151M [A62V, V75I, F77L, F116Y, Q151M] será excluyente.
    4)Estar recibiendo actualmente una pauta antirretroviral formada por FTC/TDF o ABC/3TC en combinación con un tercer antirretroviral durante ?6 meses consecutivos antes de la visita de selección.
    5) Concentración plasmática documentada de ARN del VIH-1 <50 copias/ml durante ?6 meses antes de la visita de selección (medida al menos dos veces con el mismo análisis).
    6) Concentración plasmática de ARN del VIH-1 <50 copias/ml en la visita de selección.
    7) ECG normal (o, si no lo es, el investigador ha determinado que carece de importancia clínica).
    8) FG estimada ?30 ml/min según la fórmula de Cockcroft-Gault para calcular el aclaramiento de creatinina
    9) Transaminasas hepáticas (ALT y AST) ?5 x límite superior de la normalidad (LSN).
    10) Bilirrubina total ?1,5 mg/dl o bilirrubina directa normal (los sujetos con síndrome de Gilbert documentado o con hiperbilirrubinemia asociada a atazanavir podrán tener una bilirrubina total de hasta 5 veces el LSN).
    11) Función hematológica adecuada (recuento absoluto de neutrófilos ?1000/mm3; plaquetas ?50.000/mm3; hemoglobina ?8,5 g/dl).
    12) Una mujer podrá participar en el estudio si se confirma que:
    a) No está embarazada, según una prueba de embarazo en suero con resultado negativo, que será obligatoria para las mujeres (salvo que presente esterilidad permanente o que hayan pasado más de dos años desde la menopausia).
    b) No puede tener hijos (por ejemplo, ha sufrido una histerectomía, se le han extirpado los dos ovarios o presenta insuficiencia ovárica documentada médicamente, o es postmenopaúsica con más de 54 años y no tiene menstruación desde hace al menos 12 meses).
    c) Las mujeres que lleven sin menstruación ?12 meses sin constancia de una insuficiencia hormonal ovárica deberán tener una concentración sérica de folitropina (FSH) de selección dentro del intervalo posmenopáusico, según el intervalo de referencia del laboratorio central.
    d) Puede tener hijos y se compromete a utilizar un método anticonceptivo señalado en el protocolo o a no mantener relaciones heterosexuales o a practicar la abstinencia sexual desde la selección, durante todo el tratamiento del estudio y hasta 30 días después de la retirada de los fármacos del estudio
    e) Las mujeres que utilicen anticonceptivos hormonales como uno de los métodos anticonceptivos deberán haber usado el mismo método durante al menos tres meses antes de la administración del fármaco del estudio.
    13) Los varones deberán comprometerse a utilizar el método anticonceptivo especificado en el protocolo cuando mantengan relaciones heterosexuales o a mantener relaciones no heterosexuales o practicar abstinencia sexual desde la selección, durante todo el período del estudio y durante 30 días siguientes a la última dosis del fármaco del estudio.
    a) Los sujetos varones tendrán que comprometerse a no donar semen desde la primera dosis y hasta 30 días después, como mínimo, de la última dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    1) Subjects will have no evidence of previous virologic failure on a PI/r or INSTI-based regimen (with or without resistance to either class of ARV). Subjects may have evidence of prior virologic failure on only an NNRTI plus 2 NRTI-based regimen.
    2) Subjects on a current PI/r-based regimen will have no evidence of previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) (for any length of time).
    3) A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4 cell count and/or percentage criteria)
    4) Hepatitis C infection that would require therapy during the study
    5) Hepatitis B surface antigen (HBsAg) positive
    6) Subjects with clinical evidence of decompensated cirrhosis (e.g., ascites, encephalopathy, variceal bleeding, etc.)
    7) Females who are breastfeeding
    8) Positive serum pregnancy test
    9) Have an implanted defibrillator or pacemaker
    10) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
    11) A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and must not be anticipated to require systemic therapy during the study
    12) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
    13) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
    14) Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
    15) Subjects receiving ongoing therapy with any of the medications in Table 4-2 and those listed in Section 5.4 of the protocol, including drugs not to be used with EVG, COBI, FTC or TAF; or subjects with any known allergies to the excipients of E/C/F/TAF FDC tablets.
    1) Pacientes sin indicios de fracaso virológico previo con una pauta de IP/r o ITCI (con o sin resistencia a algunas de las clases de ARV). Los pacientes pueden presentar indicios de fracaso virológico previo solo con una pauta a base de un ITINN más dos ITIAN.
    2) Pacientes con una pauta actua de IP/r sin indición de uso previo de ningún inhibidor de la transferencia de cadenas de la integrasa (ITCI) autorizado o experimental (durante cualquier periodo).
    3) Diagnóstico de una nueva afección definitoria de SIDA en los 30 días previos a la visita de selección (exceptuando los criterios de recuento y/o porcentaje de linfocitos CD4+)
    4) Infección por el virus de la hepatitis C que podría requerir tratamiento durante el estudio.
    5) Antígeno de superficie del virus de la hepatitis B (HBsAg) positivo.
    6) Sujetos con signos clínicos de cirrosis descompensada (ascitis, encefalopatía, varices hemorrágicas, etc.).
    7) Mujeres en período de lactancia.
    8) Prueba de embarazo en suero positiva.
    9) Presencia de un desfibrilador o marcapasos implantado.
    10) Consumo activo de alcohol o sustancias que, según el criterio del investigador, podría afectar al cumplimiento del estudio.
    11) Antecedentes de neoplasia maligna en los cinco años precedentes (previos a la selección) o de neoplasia maligna activa distinta de un sarcoma de Kaposi (SK) cutáneo, carcinoma basocelular o carcinoma espinocelular de piel no invasivo resecado. Los sujetos con SK cutáneo podrán participar, pero no podrán haber recibido un tratamiento sistémico contra el SK en los 30 días previos al día 1 ni deberá haber previsión de que necesitarán tratamiento sistémico durante el estudio.
    12) Infecciones graves activas (aparte de la infección por el VIH-1) que requieran tratamiento parenteral con antibióticos o antifúngicos en los 30 días previos al día 1.
    13) Cualquier otra afección clínica o tratamiento previo que, en opinión del investigador, haga que el sujeto no sea adecuado para el estudio o no sea capaz de cumplir los requisitos de administración.
    14) Durante la participación en este estudio queda prohibida la participación en cualquier otro ensayo clínico (incluidos ensayos observacionales) sin la aprobación previa del promotor.
    15) Tratamiento activo con cualquiera de los medicamentos indicados en la tabla 4-2 y los recogidos en la sección 5.4 del protocolo, incluidos los que no deben utilizarse con EVG, COBI, FTC o TAF, o alergia conocida a los excipientes de los comprimidos de la CDF de E/C/F/TAF.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects with HIV-1 RNA <50 copies/mL at Week 12 as defined by pure virologic response.
    ?ARN del VIH-1 <50 copias/ml en la semana 12 según la respuesta virológica pura (RVP).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    1) Emergence of new mutations in HIV-1 reverse transcriptase and integrase (attempted on any post Day 1 sample with HIV-1 RNA ? 50 copies/mL)
    2) HIV-1 RNA< 50 copies/mL at Weeks 24 and 48 using PVR
    3) HIV-1 RNA < 50 copies/mL at Weeks 12, 24 and 48 using the FDA snapshot analysis (sensitivity analysis)
    4) CD4+ cell count change from Day 1 at Weeks 12, 24 and 48
    1) Aparición de nuevas mutaciones en la transcriptasa inversa y la integrasa del VIH-1 (intentado con la muestra obtenida cualquier día después del día 1 con un ARN del VIH-1 ?50 copias/ml).
    2) ARN del VIH-1 <50 copias/ml en las semanas 24 y 48 según la RVP.
    3) ARN del VIH <50 copias/ml en las semanas 12, 24 y 48 según el análisis de instantáneas de la FDA (análisis de sensibilidad).
    4) Variación del recuento de linfocitos CD4+ entre el día 1 y las semanas 12, 24 y 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) at any time post day 1
    2) at Weeks 24 and 48
    3) at Weeks 12, 24 and 48
    4) at Weeks 12, 24 and 48
    1) en cualquier momento después del día 1
    2) en las semanas 24 y 48
    3) en las semanas 12, 24 y 48
    4) en las semanas 12, 24 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 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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 No
    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.8.2.4Number of treatment arms in the trial1
    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 EEA29
    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 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 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 months8
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 5
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    After a subject has completed/terminated their participation in the study, long-term care for the subject will remain the responsibility of their primary treating physician.
    Después de que un sujeto haya completado / terminado su participación en el estudio, el cuidado a largo plazo para el sujeto seguirá siendo responsabilidad de su médico de atención primaria.
    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 Decision2015-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-11
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