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    Summary
    EudraCT Number:2015-002415-15
    Sponsor's Protocol Code Number:TG-MV-015
    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:2016-02-17
    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 number2015-002415-15
    A.3Full title of the trial
    A PHASE 2, RANDOMISED, DOUBLE-MASKED, SHAM-CONTROLLED, MULTI-CENTRE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRIPLASMIN IN INDUCING TOTAL POSTERIOR VITREOUS DETACHMENT (PVD) IN SUBJECTS WITH NON-PROLIFERATIVE DIABETIC RETINOPATHY (NPDR) (CIRCLE)
    Estudio de fase 2, aleatorizado, en doble ciego, controlado con tratamiento simulado y multicéntrico, para evaluar la eficacia y la seguridad de la ocriplasmina en la inducción de un desprendimiento completo del vítreo posterior (DVP) en sujetos con retinopatía diabética no proliferativa (RDNP) (Estudio CIRCLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRIPLASMIN IN INDUCING TOTAL POSTERIOR VITREOUS DETACHMENT IN SUBJECTS WITH NON-PROLIFERATIVE DIABETIC RETINOPATHY
    Estudio para evaluar la eficacia y la seguridad de la ocriplasmina en la inducción de un desprendimiento completo del vítreo posterior en sujetos con retinopatía diabética no proliferative.
    A.3.2Name or abbreviated title of the trial where available
    CIRCLE
    CIRCLE
    A.4.1Sponsor's protocol code numberTG-MV-015
    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 SponsorThromboGenics NV
    B.1.3.4CountryBelgium
    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 supportThromboGenics NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThromboGenics NV
    B.5.2Functional name of contact pointGlobal Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressGaston Geenslaan 1
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post codeB-3001
    B.5.3.4CountryBelgium
    B.5.4Telephone number3491 3913443
    B.5.5Fax number32(0)16751311
    B.5.6E-mailinfo@thrombogenics.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 Yes
    D.2.1.1.1Trade name JETREA 0.5 mg/0.2 mL concentrate for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderThromboGenics NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Concentrate for 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 INNOCRIPLASMIN
    D.3.9.1CAS number 1048016-09-6
    D.3.9.4EV Substance CodeSUB33018
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 Yes
    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
    Moderately severe to very severe non-proliferative diabetic retinopathy (NPDR)
    De moderadamente severa a muy severa retinopatía diabética no proliferativa (RDNP)
    E.1.1.1Medical condition in easily understood language
    Eye problems caused by diabetes (called 'diabetic retinopathy')
    Problemas en los ojos causados por diabetes (denominado "Retinopatia diabetic)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10054109
    E.1.2Term Non-proliferative diabetic retinopathy
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderately severe to very severe NPDR, to induce total PVD in order to reduce the risk of disease progression to PDR
    Evaluar la eficacia y la seguridad de un máximo de 3 inyecciones intravítreas de ocriplasmina (0,0625 mg o 0,125 mg), en sujetos con RDNP moderadamente severa a muy severa, en cuanto a la inducción de un DVP completo a fin de reducir el riesgo de progresión de la enfermedad a RDP
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female aged 18 years or older
    - BCVA of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye
    - BCVA of 20 letters read or greater (Snellen equivalent of 20/400 or better) in the fellow eye
    - Clear ocular media for adequate fundus imaging in the study eye
    - HbA1c ? 12%, as assessed by the central laboratory
    - Moderately severe to very severe NPDR as per ETDRS Severity Scale (Levels 47B-53E), based on 7 standard field colour fundus photograph, as assessed by the central reading centre (CRC)
    - No evidence of total PVD in the study eye, based on both B-scan ultrasound and SD-OCT, as assessed by the B-scan expert reader and the CRC, respectively
    - Written informed consent obtained from the subject prior to screening procedures
    - Hombres o mujeres de como mínimo 18 años de edad
    - AVCC de lectura de 65 letras o más (equivalente de Snellen de 20/50 o mejor) en el ojo en estudio
    - AVCC de 20 letras o más (equivalente de Snellen de 20/400 o mejor) en el ojo contralateral
    - Medios oculares trasparentes para el examen adecuado del fondo de ojo en estudio
    - HbA1c <= 12%, según el laboratorio central
    - RDNP moderadamente severa a muy severa según la ETDRS Severity Scale (Niveles 47B-53E), basada en la estereofotografía en color de 7 campos estándar de fondo de ojo, en su evaluación por el CRC
    - Sin evidencia de DVP completo en el ojo en estudio, basada en la ecografía en modo B y en la SD-OCT, en su evaluación, respectivamente, por el lector experto en ecografía en modo B y por el CRC
    - Obtención del consentimiento informado por escrito del sujeto antes de los procedimientos de la selección
    E.4Principal exclusion criteria
    - History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR (e.g. exudative AMD, retinal vein occlusion [branch or central vein], uveitis, angioid streaks, histoplasmosis, toxoplasmosis, rhegmatogenous retinal detachment, retinal tear, fibrovascular proliferation, lattice degeneration, macular hole, ocular tumours)
    - Clinically significant centre-involving DME in the study eye, based on SD-OCT, as assessed by the CRC
    - Clinically significant CME in the study eye, based on SD-OCT, as assessed by the CRC
    - Significant ocular trauma in the study eye within 6 months prior to screening (including corneo scleral laceration, lens subluxation, cryo-retinopexy)
    - Corneal, lenticular, or ocular media abnormalities in the study eye that preclude observation with the slit lamp or accurate readings with a tonometer
    - Presence of epiretinal membrane in the study eye, based on SD-OCT, as assessed by the CRC
    - Presence of foveal ischemia, macular vascularisation or peripheral non-perfusion in the study eye, based on fluorescein angiograph, as assessed by the CRC
    - Presence of pre-retinal or vitreous haemorrhage in the study eye
    - Presence of iris or angle neovascularisation in the study eye
    - Any active ocular / intraocular infection or inflammation in either eye (e.g. blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, uveitis)
    - Open angle glaucoma or uncontrolled glaucoma in the study eye (uncontrolled glaucoma is defined as intraocular pressure [IOP] ? 26mmHg despite treatment with anti-glaucoma medication)
    - More than 8D high myopia in the study eye (axial length of > 26.0mm on A-scan ultrasound)
    - Aphakic study eye
    - Previous treatments / procedures in the stydy eye as follows: vitrectomy, PRP and Steroid implants [any time] // Intraocular surgery and Intravitreal and peri-ocular steroids [4 months] // Focal / grid laser photocoagulation and Intravitreal anti-VEGF [3 months] // Topical ocular steroids [1 month] [excluded period period to randomisation]
    - Uncontrolled hypertension in the opinion of the Investigator (e.g. systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg for at least 30 days prior to screening despite antihypertensive treatment, or any finding in the Investigator?s opinion suggesting hypertensive retinopathy)
    - Pseudoexfoliation, Marfan?s syndrome, phacodonesis or any other finding in the Investigator?s opinion suggesting lens / zonular instability
    - Current use of or possible need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine / hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol
    - Known hypersensitivity to ocriplasmin, its excipients or any of the medications that will be used for study procedures (e.g. fluorescein, antibiotics, anaesthetic eye drops, eye drops for pupil dilation)
    - Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception (where 1 method is barrier at the minimum)
    - Previous ocriplasmin injection in the study eye
    - History and / or current evidence of a systemic medical condition or any other reason that may, in the Investigator?s opinion, preclude adherence to the scheduled study visits / assessments and safe participation in the study
    - Concurrent participation in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non investigational product (pharmaceutical product or device)
    - Use of any investigational, non-registered or off-label product within 30 days prior to screening, or planned use during the entire study period
    - Historia o presencia de trastorno ocular actual en el ojo en estudio que pueda interferir con la evaluación de la progresión a RDP (por ejemplo, DMRE de tipo exudativo, oclusión de vena retiniana [de una rama o de la vena central], uveítis, estrías angioides, histoplasmosis, toxoplasmosis, desprendimiento de retina regmatógeno, desgarro de retina, proliferación fibrovascular, degeneración reticular (lattice), agujero macular, tumores oculares)
    - EMD que afecta al centro clínicamente significativo en el ojo en estudio, basado en la SD-OCT, en su evaluación por el CRC
    - EMC clínicamente significativo en el ojo en estudio, basado en la SD-OCT, en su evaluación por el CRC
    - Traumatismo ocular importante en el ojo en estudio en el plazo de los 6 meses anteriores a la selección (incluidas laceración corneoescleral, subluxación de cristalino, criorretinopexia)
    - Anomalías corneales, lenticulares o de los medios oculares en el ojo en estudio que impidan la observación con lámpara de hendidura o la lectura con precisión con tonómetro
    - Presencia de membrana epirretiniana en el ojo en estudio, basada en la SD-OCT, en su evaluación por el CRC
    - Presencia de isquemia foveal, vascularización macular o ausencia de perfusión tisular periférica en el ojo en estudio, basada en la angiografía con fluoresceína, en su evaluación por el CRC
    -Presencia de hemorragia prerretiniana o vítrea en el ojo en estudio
    - Presencia de neovascularización del iris o del ángulo en el ojo en estudio
    - Todo proceso activo de infección o inflamación ocular / intraocular en cualquier ojo (por ejemplo, blefaritis, conjuntivitis infecciosa, queratitis, escleritis, endoftalmitis, uveítis)
    - Glaucoma de ángulo abierto o glaucoma no controlado en el ojo en estudio (el glaucoma no ontrolado se define como una presión intraocular [PIO] >= 26 mm Hg a pesar del tratamiento con medicación anti-glaucoma)
    - Miopía de más de 8D en el ojo en estudio (longitud axial > 26,0 mm en ecografía en modo A u otro método no invasivo)
    - Ojo en estudio afáquico
    Los siguientes tratamientos/procedimientos previos: Vitrectomía; FPR e Implantes corticoideos (en cualquier momento) // Cirugía intraocular y Corticosteroides intravítreos y perioculares (4 meses)// Fotocoagulación focal/con láser en parrilla y Tratamiento intravítreo con fármacos anti-VEGF (3 meses)// Corticosteroides orales tópicos (1 mes)(se excluye el periodo de aleatorización)
    - Hipertensión no controlada en opinión del Investigador (esto es, presión arterial sistólica > 160 mm Hg o diastólica> 100 mm Hg como mínimo en los 30 días anteriores a la selección a pesar del tratamiento antihipertensivo, o cualquier hallazgo que, en opinión del Investigador, sugiera una retinopatía hipertensiva)
    - Pseudoexfoliación, síndrome de Marfan, facodonesis o cualquier otro hallazgo que, en opinión del Investigador, sugiera inestabilidad de cristalino/ zonular
    - Uso actual o posible necesidad de medicamentos sistémicos que se sabe que son tóxicos para el cristalino, la retina o el nervio óptico, incluyendo deferoxamina, cloroquina / hidroxicloroquina (Plaquenil), tamoxifeno, fenotiazinas y etambutol
    - Hipersensibilidad conocida a la ocriplasmina, sus excipientes o cualquiera de los medicamentos que se van a utilizar en los procedimientos del estudio (por ejemplo, fluoresceína, antibióticos, colirios anestésicos, colirios para la dilatación pupilar)
    - Mujeres embarazadas o que están amamantando, o mujeres potencialmente fértiles que no utilicen una anticoncepción adecuada, o varones potencialmente fértiles que no utilicen anticoncepción (como mínimo 1 método de barrera)
    - Inyección previa de ocriplasmina en el ojo en estudio
    - Historia de y/o evidencia actual de trastorno médico sistémico o cualquier otra razón que, en opinión del Investigador, impidiera el cumplimiento con las visitas /las evaluaciones programadas del estudio y la participación segura en el estudio
    - Participación actual en otro estudio clínico, en cualquier momento de todo el período del estudio, en el que el sujeto haya estado o vaya estar expuesto a otro producto, ya sea o no experimental (medicamento o producto sanitario)
    - Uso de cualquier producto experimental, no registrado o de forma distinta a la aprobada, en el plazo de los 30 días anteriores a la selección, o previsión de su uso en cualquier momento del periodo del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Total PVD by the Month 3 visit, confirmed on both B-scan ultrasound and SD-OCT (6mm), as assessed by the masked B-scan expert reader and the masked CRC, respectively
    DVP completo a fecha de la visita del Mes 3, confirmado mediante ecografía en modo B y SD OCT (6 mm), en su evaluación, con desconocimiento del tratamiento, por el lector experto en ecografía en modo B y el CRC, respectivamente
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 3 visit
    Visita del mes 3
    E.5.2Secondary end point(s)
    Principal safety endpoints:
    - Ocular TEAEs in the study eye
    Safety will be further assessed through reported TEAEs, full ophthalmic examination, BCVA assessment, assessment of colour vision (subset), SD-OCT, ffERG (subset) and assessment of immunogenicity
    Criterio principal de valoración de la seguridad:
    - AAST oculares en el ojo en estudio
    La seguridad se evaluará adicionalmente mediante: AAST comunicados, exploraciones oftalmológicas completas, medición de la AVCC, evaluación de la visión de color (subgrupo), SD-OCT, ffERG (subgrupo) y estudio de la inmunogenia
    E.5.2.1Timepoint(s) of evaluation of this end point
    From the time of providing consent until the end of the study.
    Desde la fecha en que se otorga el consentimiento hasta el final del estudio.
    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 Yes
    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
    Viales vacios para tto simulado, no penetra en el globo, el investigador inmita proc. de inyección
    Sham empty vials, no penetration of the globe, Investigator to mimic the test injection procedure
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is defined as the last visit of the last subject (LVLS) unless the data monitoring committee (DMC) recommends premature termination of the trial as a result of safety concerns.
    El final del ensayo se define como la ultima visita del ultimo sujeto (LVLS) a no ser que el Comite de Monitorización de datos recomiende una terminación prematura del ensayo debido a problemas de seguridad.
    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 days21
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days21
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 127
    F.4.2.2In the whole clinical trial 230
    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)
    Not applicable
    No aplicable
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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