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    Summary
    EudraCT Number:2017-004783-35
    Sponsor's Protocol Code Number:OPH2005
    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:2018-02-02
    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 number2017-004783-35
    A.3Full title of the trial
    A Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects with Autosomal Recessive Stargardt Disease
    Estudio de fase IIb, aleatorizado, doble ciego y controlado para establecer la seguridad y la eficacia de Zimura™ (inhibidor del C5 del complemento) en comparación con un tratamiento simulado en pacientes con enfermedad de Stargardt autosómica recesiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura in Subjects with Autosomal Recessive Stargardt Disease
    Ensayo Clínico para evaluar la seguridad y la eficacia de la administración intravítrea de Zimura en sujetos con enfermedad de Stargardt autosómica recesiva
    A.4.1Sponsor's protocol code numberOPH2005
    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 SponsorOPHTHOTECH CORPORATION
    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 supportOPHTHOTECH CORPORATION
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPHTHOTECH CORPORATION
    B.5.2Functional name of contact pointPatricia Johnson
    B.5.3 Address:
    B.5.3.1Street AddressOne Penn Plaza, 35th floor
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10119
    B.5.3.4CountryUnited States
    B.5.6E-mailpatricia.johnson@ophthotech.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.3.1Product nameZimura
    D.3.2Product code ARC1905
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNavacincaptad pegol
    D.3.9.2Current sponsor codeARC1905
    D.3.9.3Other descriptive nameARC1905 20 MG/ML
    D.3.9.4EV Substance CodeSUB30770
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Autosomal Recessive Stargardt Disease
    Enfermedad de Stargardt autosómica recesiva
    E.1.1.1Medical condition in easily understood language
    Autosomal Recessive Stargardt Disease
    Enfermedad de Stargardt autosómica recesiva
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10062766
    E.1.2Term Stargardt's disease
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to evaluate the safety and efficacy of Zimura™ intravitreal injection compared to Sham in subjects with autosomal recessive Stargardt disease 1 (STGD1).
    Los objetivos de este estudio son evaluar la seguridad y la eficacia de la inyección intravítrea de Zimura™ en comparación con un tratamiento simulado en pacientes con enfermedad de Stargardt autosómica recesiva 1 (STGD1).
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Ophthalmic Inclusion Criteria
    The following inclusion criteria apply to the study eye:
    - At least two pathogenic mutations of ABCA4 gene confirmed by a CLIA-certified laboratory.
    - Best corrected visual acuity in the study eye between 20/20 - 20/200 Snellen equivalent, inclusive.
    - Presence of at least one identifiable location of at least 250 micrometers contiguous width of ellipsoid zone loss on SD-OCT within the total 9 ETDRS subfields.
    - The total area of thinned layer(s) on OCT not extending beyond the outer ring of the total 9 ETDRS subfields (e.g. not extending beyond fields 5-9).
    - Fundus autofluorescence may show heterogeneous signals (areas of increased and/or decreased autofluorescence) but no area of subfoveal definitely decreased autofluorescence (DDAF).
    - Clear ocular media and adequate pupillary dilatation in both eyes (OU) to allow for all imaging procedures, including good quality stereoscopic fundus photography, fundus autofluorescence, and spectral domain ocular coherence tomography.
    - Intraocular pressure of 21 mmHg or less in the study eye.
    General Inclusion Criteria
    - Subjects of either gender aged between 18 and 50 years, inclusive.
    - Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 90 days following the last dose of test medication. Male subjects should use a condom during the time of study drug exposure and for 90 days following last exposure of study drug.
    - Provide written informed consent.
    - Ability to return for all trial visits.
    Criterios de inclusión oftálmicos
    Los criterios de inclusión siguientes corresponden al ojo en estudio:
    - Al menos dos mutaciones patógenas del gen ABCA4 confirmadas por un laboratorio certificado por CLIA.
    - Mejor agudeza visual corregida del ojo en estudio con valores comprendidos entre 20/20 - 20/200 equivalente en Snellen, inclusive.
    - Presencia de al menos una ubicación identificable de al menos 250 micras de anchura contigua de pérdida de la zona elipsoide en la TCO-DE en los 9 subcampos de ETDRS totales.
    - La superficie total de las capas adelgazadas en la TCO no se extiende más allá del anillo exterior de los 9 subcampos de ETDRS totales (p. ej., no se extiende más allá de los campos 5-9).
    - La autofluorescencia del fondo de ojo puede mostrar señales heterogéneas (zonas de aumento y/o reducción de autofluorescencia) pero ninguna zona de disminución definida de la autofluorescencia (DDAF) subfoveal.
    - Medios oculares claros y dilatación pupilar adecuada en ambos ojos (AO) para permitir todos los procedimientos de obtención de imágenes, incluida una buena fotografía del fondo de ojo, con autofluorescencia del fondo de ojo y tomografía de coherencia ocular de dominio espectral.
    - Presión intraocular de 21 mmHg o menos en el ojo en estudio.
    Criterios generales de inclusión
    - Pacientes de ambos sexos entre 18 y 50 años de edad, inclusive.
    - Las mujeres deben utilizar dos métodos anticonceptivos eficaces, encontrarse en la etapa posmenopáusica al menos en los 12 meses previos a la inclusión en el ensayo clínico o ser estériles quirúrgicamente. En caso de encontrarse en edad fértil, debe obtenerse un resultado negativo en la prueba de embarazo en suero realizada en los 14 días previos a la primera inyección. Los dos métodos anticonceptivos eficaces tienen que utilizarse durante la participación en el ensayo clínico y, como mínimo, durante los 90 días posteriores a la última dosis de la medicación en estudio. Los pacientes varones deben utilizar un preservativo durante el período de exposición al fármaco del estudio y durante 90 días después de la última exposición al fármaco del estudio.
    - Dar consentimiento informado por escrito.
    - Capacidad para acudir a todas las visitas del estudio.
    E.4Principal exclusion criteria
    Subjects will not be eligible for the trial if subjects cannot attend all of the trial required visits, or if any of the following criteria are present in the study eye or systematically:

    Ophthalmic Exclusion Criteria
    - Macular atrophy secondary to any condition other than STGD1 in either eye (e.g., drug-induced).
    - Any prior treatment for STGD1 including gene therapy, stem cell therapy or any prior intravitreal treatment for any indication in either eye.
    - Participation in an interventional study of a vitamin A derivative ≤ 3 months prior to screening.
    - Any ocular condition in the study eye that would progress during the course of the study that could affect central vision, microperimetry testing or otherwise be a confounding factor.
    - Concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina or optic nerve.
    - Presence of intraocular inflammation (≥ trace cell or flare), macular hole, pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), epiretinal membrane, evidence of significant vitreo-macular traction, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an exclusion criteria).
    - Presence or history of idiopathic or autoimmune-associated uveitis in either eye.
    - Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, fundus photography or fundus autofluorescence. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye during the study.
    - Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
    - Any ocular or periocular infection or ocular surface inflammation in the past 12 weeks.
    - History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.

    General Exclusion Criteria
    - Any of the following underlying diseases including:
    • Diabetes mellitus (regardless of HbA1c level)
    • HbA1c value of ≥6.5%*:
    • If the HbA1c value is ≥ 6.5% and ≤ 6.9%, and the patient has no signs or symptoms of diabetes mellitus, has a normal creatinine, has no diabetic retinopathy and no glycosuria, then the patient may have an oral glucose tolerance test (OGTT) at the discretion of the investigator. If the 2-hour glucose value on OGTT is <200 mg/dL (<11.1mmol/L), then the patient may be enrolled.
    • History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
    • History or evidence of severe cardiac disease (eg, New York Heart Association (NYHA) Functional Class III or IV - see Appendix 17.5), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrhythmia requiring ongoing treatment.
    • Subjects with a clinically significant laboratory value. Laboratory tests may be repeated once before randomization.
    • Stroke within 12 months of trial entry.
    • Any major surgical procedure within one month of trial entry or anticipated during the trial which may interrupt trial participation.
    - Previous therapeutic radiation in the region of the study eye.
    - Any treatment with an investigational agent in the past 60 days for any condition.
    - Women who are pregnant or nursing.
    - Known serious allergies to the fluorescein dye used in angiography, povidone iodine, or to the components of the Zimura™ formulation.
    - History of systemic treatment with any complement inhibitor agent in the past or the likelihood of treatment with any systemic complement inhibitor agent during the study.
    Los pacientes no serán aptos para el ensayo si no pueden acudir a todas las visitas del ensayo necesarias o si cumplen alguno de los siguientes criterios en el ojo en estudio o sistemáticamente:
    Criterios de exclusión oftálmicos
    Los criterios de exclusión siguientes se aplican al ojo en estudio a menos que se indique lo contrario:
    - Atrofia macular secundaria a cualquier enfermedad distinta de ESTG1 en cualquier ojo (p. ej., inducida por fármacos).
    - Cualquier tratamiento previo para la ESTG1, incluidos terapia génica, terapia con células madre o cualquier tratamiento intravítreo previo para cualquier indicación en cualquier ojo.
    - Participación en un estudio intervencionista de un derivado de la vitamina A ≤ 3 meses antes de la selección.
    - Cualquier afección ocular en el ojo en estudio que progrese durante el transcurso del estudio que podría afectar a la visión central, a las pruebas microperimetría o que podría ser un factor de confusión.
    - Tratamiento concomitante con cualquier medicamento ocular o sistémico del que se sabe que es tóxico para el cristalino, la retina o el nervio óptico.
    - Presencia de inflamación intraocular (≥ traza o exacerbación), agujero macular, miopía patológica (equivalente esférico de -8 dioptrías o más negativo, o longitud axial de 25 mm o más), membrana epirretiniana, indicios de tracción vítreo-macular significativa, hemorragia vítrea o afaquia (la pseudofaquia con o sin cápsula intacta no es un criterio de exclusión).
    - Presencia o antecedentes de uveítis idiopática o asociada a algún trastorno autoinmunitario en cualquiera de los ojos.
    - Opacidades de medios significativas, como cataratas, que pueden interferir en la agudeza visual, la evaluación de la toxicidad, la retinografía o la autofluorescencia del fondo del ojo. No debe incluirse a pacientes con probabilidad de cirugía de cataratas en el ojo en estudio durante el estudio.
    - Cualquier intervención quirúrgica intraocular o procedimiento con láser térmico en los 3 meses previos a la inclusión en el estudio. Cualquier procedimiento previo con láser térmico en la región macular, con independencia de la indicación.
    - Cualquier infección ocular o periocular o inflamación de la superficie ocular en las 12 semanas anteriores.
    - Antecedentes de cualquiera de los siguientes procedimientos: Vitrectomía posterior, cirugía filtrante (p. ej., trabeculectomía), dispositivo de drenaje de glaucoma, trasplante corneal o desprendimiento de retina.
    Criterios de exclusión generales
    Cualquiera de las enfermedades subyacentes siguientes:
    • Diabetes mellitus (con independencia del nivel de HbA1c)
    • Valor de HbA1c ≥ 6,5 %*:
    Si el valor de HbA1c es ≥ 6,5 % y ≤ 6,9 %, y el paciente no presenta signos ni síntomas de diabetes mellitus, tiene la creatinina normal y no tiene retinopatía diabética ni glucosuria, entonces se le puede realizar una prueba de tolerancia oral a la glucosa (PTOG) si el investigador lo considera oportuno. Si el valor de glucosa a las 2 horas de la PTOG es < 200 mg/dl (< 11,1 mmol/l), se puede incluir al paciente en el estudio.
    • Antecedentes de otras enfermedades, disfunción metabólica, hallazgo de la exploración física o de los resultados analíticos clínicos según el cual exista una sospecha razonable de que el paciente padece una enfermedad o afección que contraindica el uso del fármaco en investigación, o que puede afectar a la interpretación de los resultados del estudio, o que ponga al paciente en riesgo alto de complicaciones debidas al tratamiento.
    • Antecedentes o signos de cardiopatía grave (p. ej., clase funcional III o IV de New York Heart Association (NYHA); véase el Anexo 17.5), antecedentes o signos clínicos de angina inestable, síndrome coronario agudo, infarto agudo de miocardio o revascularización en los 6 meses anteriores, o taquiarrítmia ventricular que requiera tratamiento continuo.
    • Pacientes con un valor analítico clínicamente significativo. Las pruebas analíticas pueden repetirse una vez antes de la aleatorización.
    • Ictus en los 12 meses previos a la inclusión en el estudio.
    • Cualquier procedimiento quirúrgico mayor en el mes anterior a la inclusión en el ensayo o previsto durante el ensayo que pueda interrumpir la participación en el mismo.
    - Radioterapia previa en la región del ojo en estudio.
    - Cualquier tratamiento con un producto en investigación en los 60 días previos a la aleatorización.
    - Mujeres embarazadas o en periodo de lactancia.
    - Alergias graves conocidas al colorante de fluoresceína utilizado en la angiografía, a la povidona yodada o a los componentes de la formulación de Zimura™.
    - Antecedentes de tratamiento sistémico con cualquier inhibidor del complemento en el pasado o probabilidad de tratamiento con cualquier inhibidor sistémico del complemento durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    • Mean rate of change in the area of ellipsoid zone defect measured by en face SD-OCT over 18 months.

    Safety Endpoints:
    • Adverse events, vital signs, ophthalmic variables [ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), fundus autofluorescence (FAF), spectral domain-optical coherence tomography (SD-OCT), microperimetry], electrocardiogram (ECG), and laboratory variables.
    Criterio principal de valoración de la eficacia
    • Tasa media de cambio en el área defectuosa de la zona elipsoide medida mediante TCO-DE en face durante 18 meses.

    Criterios de valoración de la seguridad:
    • Acontecimientos adversos, constantes vitales, variables oftalmológicas [exploración oftalmológica, presión intraocular (PIO), angiograma con fluoresceína (AF), autofluorescencia del fondo de ojo (FAF), tomografía de coherencia óptica de dominio espectral (TCO-DE), microperimetría], electrocardiografía (ECG) y variables analíticas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Month 18
    Basal hasta Mes 18
    E.5.2Secondary end point(s)
    Secondary and Supportive Endpoints
    • Mean rate of change in the horizontal width of undetectable ellipsoid zone measured by a horizontal scan through the foveal center with SD-OCT over 18 months.
    • Mean rate of change in the area of atrophic lesion (definite decrease in autofluorescence, DDAF) over 18 months measured by fundus autofluorescence (FAF).
    • Mean change in photopic and/or mesopic macular sensitivity measured by microperimetry from Baseline to Month 18.
    • Mean rate of change in the thickness of the outer nuclear layer measured by a horizontal scan through the foveal center at the position of maximum width of ellipsoid zone loss at Baseline over 18 months measured by SD-OCT.
    • Mean change in best corrected visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from Baseline to Month 18.
    • Emergence of at least one new atrophic lesion (DDAF) over 18 months measured by FAF at Month 18.
    Criterios de valoración secundarios y complementarios
    • Tasa media de cambio en la anchura horizontal de la zona elipsoide indetectable medida mediante exploración horizontal a través del centro foveal con TCO-DE durante 18 meses.
    • Tasa media de cambio en el área con lesión atrófica (reducción definitiva de la autofluorescencia, DDAF) durante 18 meses medida mediante autofluorescencia del fondo de ojo (FAF).
    • Cambio medio en la sensibilidad macular fotópica y/o mesópica medida por microperimetría desde el inicio hasta el mes 18.
    • Tasa media de cambio en el grosor de la capa nuclear externa medida mediante exploración horizontal a través del centro foveal en la posición de anchura máxima de la pérdida de zona elipsoidal con TCO-DE desde el inicio y durante 18 meses.
    • Cambio medio en la mejor agudeza visual corregida (letras del Estudio del tratamiento temprano de la retinopatía diabética [ETDRS, por sus siglas en inglés]) desde el inicio hasta el mes 18.
    • Aparición de al menos una nueva lesión atrófica (DDAF) durante 18 meses medida mediante FAF en el mes 18.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to Month 18
    Basal hasta Mes 18
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Zimura and sham administered by an unmasked investigator
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States 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
    Canada
    France
    Germany
    Hungary
    Israel
    Italy
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS (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 months6
    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 months8
    E.8.9.2In all countries concerned by the trial days15
    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: 120
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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 Decision2018-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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