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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-002415-15
    Sponsor's Protocol Code Number:TG-MV-015
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-02
    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 ConcernedFrance - ANSM
    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)
    Étude multicentrique de phase 2, randomisée, en double insu, contrôlée avec injection simulée, destinée à évaluer l’efficacité et la tolérance de l’ocriplasmine sur l’induction d’un Décollement total Postérieur du Vitré (DPV) chez des patients présentant une Rétinopathie Diabétique Non Proliférante (RDNP) (étude 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
    Étude destinée à évaluer l’efficacité et la tolérance de l’ocriplasmine sur l’induction d’un Décollement total Postérieur du Vitré chez des patients présentant une Rétinopathie Diabétique Non Proliférante
    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 number32(0)16751310
    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)
    Rétinopathie Diabétique Non Proliférante (RDNP) modérément sévère à très sévère
    E.1.1.1Medical condition in easily understood language
    Eye problems caused by diabetes (called 'diabetic retinopathy')
    Problèmes oculaires liés au diabète (rétinopathie diabétique)
    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
    L’objectif est d’évaluer l’efficacité et la tolérance d’un maximum de 3 injections intravitréennes d’ocriplasmine (0,0625 mg ou 0,125 mg), chez des patients atteints de RDNP modérément sévère à très sévère, sur l’induction d’un DPV total afin de réduire le risque d’évolution de la maladie vers une RDP.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicable
    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
    - Homme ou femme âgé(e) d’au moins 18 ans
    - Meilleure acuité visuelle corrigée (MAVC) d’au moins 65 lettres lues ou plus (équivalent Snellen de 20/50 ou mieux) dans l’oeil à l’étude
    - MAVC d’au moins 20 lettres lues ou plus (équivalent Snellen de 20/400 ou mieux) dans l’autre oeil
    - Milieux oculaires transparents pour une imagerie appropriée du fond de l’oeil à l’étude
    - Taux d’HbA1c ≤ 12 %, d’après l’évaluation du laboratoire central
    - RDNP modérément sévère à très sévère sur l’échelle de sévérité ETDRS (niveaux 47B-53E), basé sur l’évaluation par le CIC des photographies stéréoscopiques couleur de 7 champs standard du fond d’oeil
    - Aucun signe de DPV total dans l’oeil à l’étude sur l’imagerie par échographie en mode B et l’imagerie SD-OCT, d’après l’évaluation effectuée respectivement par l’expert en échographie en mode B et le Centre d'interprétation central (CIC)
    - Consentement éclairé écrit obtenu du patient avant toute activité de sélection
    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
    - Antécédents ou présence d’une pathologie oculaire dans l’oeil à l’étude, susceptible d’interférer sur l’évaluation de l’évolution vers une RDP (par exemple, dégénérescence maculaire liée à l’âge [DMLA] exsudative, occlusion veineuse rétinienne [branche veineuse rétinienne ou veine centrale de la rétine], uvéite, stries angioïdes, histoplasmose, toxoplasmose, décollement rhegmatogène rétinien, déchirure rétinienne, prolifération fibrovasculaire, dégénérescence en treillis, trou maculaire, tumeurs oculaires)
    - OEdème maculaire diabétique (OMD) cliniquement significatif impliquant le centre de l’oeil à l’étude, d’après l’évaluation effectuée par le CIC de l’imagerie SD-OCT
    - OEdème maculaire cystoïde (OMC) cliniquement significatif dans l’oeil à l’étude, d’après l’évaluation effectuée par le CIC de l’imagerie SD-OCT
    - Traumatisme oculaire significatif dans l’oeil à l’étude dans les 6 mois précédant la sélection (y compris lacération cornéo-sclérale, subluxation du cristallin, cryorétinopexie)
    - Anomalies des milieux oculaires, cornéens, ou lenticulaires dans l’oeil à l’étude empêchant l’observation à la lampe à fente ou des interprétations précises de tonométrie
    - Présence d’une membrane épirétinienne dans l’oeil à l’étude, d’après l’évaluation effectuée par le CIC de l’imagerie SD-OCT
    - Présence d’une ischémie fovéenne, d’une vascularisation maculaire ou d’une non-perfusion périphérique dans l’oeil à l’étude, d’après l’évaluation effectuée par le CIC de l’angiographie à la fluorescéine
    - Présence d’une hémorragie pré-rétinienne ou vitrée dans l’oeil à l’étude
    - Présence d’une néovascularisation de l’iris ou de l’angle dans l’oeil à l’étude
    - Infection ou inflammation active oculaire / intra-oculaire dans l’un ou l’autre oeil (par exemple, blépharite, conjonctivite infectieuse, kératite, sclérite, endophtalmie, uvéite)
    - Glaucome à angle ouvert ou glaucome non contrôlé dans l’oeil à l’étude (le glaucome non contrôlé est défini comme la présence d’une pression intra-oculaire [PIO] ≥ 26 mmHg malgré un traitement antiglaucomateux)
    - Présence d’une myopie élevée, supérieure à 8D, dans l’oeil à l’étude (longueur axiale > 26,0 mm sur l’échographie en mode A ou tout autre mesure non invasive)
    - OEil à l’étude aphake
    - Traitements / interventions antérieur(e)s suivant(e)s : Vitrectomie, Photocoagulation panrétinienne (PPR) et Implants de corticoïdes [A tout moment] // Chirurgie intra-oculaire et Corticoïdes intravitréens et péri-oculaires [4 mois] // Photocoagulation laser focale / en grille et Administration intravitréenne d’anti-VEGF [3 mois] // Corticoïdes topiques oculaires [1 mois] [Période d’exclusion avant la randomisation]
    - Hypertension artérielle non contrôlée, d’après l’investigateur (par exemple, pression artérielle systolique> 160 mmHg ou pression artérielle diastolique > 100 mmHg pendant au moins 30 jours avant la sélection malgré un traitement anti-hypertenseur ou toute anomalie évoquant une rétinopathie hypertensive, d’après l’investigateur)
    - Pseudo-exfoliation, syndrome de Marfan, phacodonèse ou toute autre anomalie évoquant une instabilité zonulaire / cristallinienne, d’après l’investigateur
    - Utilisation en cours ou besoin possible de médicaments systémiques connus pour être toxiques pour le cristallin, la rétine ou le nerf optique, y compris la déféroxamine, la chloroquine / l’hydroxychloroquine (Plaquénil), le tamoxifène, les phénothiazines et l’éthambutol
    - Hypersensibilité connue à l’ocriplasmine, ses excipients ou à des médicaments utilisés pour les activités/examens de l’étude (par exemple, fluorescéine, antibiotiques, collyres anesthésiques, collyres induisant une dilatation pupillaire)
    - Grossesse ou allaitement, ou absence d’utilisation d’une méthode efficace de contraception chez une femme en âge de procréer ou un homme apte à procréer (c’est-à-dire utilisant au minimum 1 méthode barrière)
    - Antécédents d’injection d’ocriplasmine dans l’oeil à l’étude
    - Antécédents et /ou présence en cours d’une pathologie médicale systémique ou toute autre raison susceptible d’empêcher, selon l’avis de l’investigateur, une observance appropriée des visites d’étude / évaluations programmées et une participation en toute sécurité à l’étude
    - Participation concomitante à une autre étude clinique, pendant toute la période de l’étude, dans laquelle le patient a été ou sera exposé à un produit à l’étude ou non à l’étude (dispositif ou produit pharmaceutique)
    - Utilisation d’un produit à l’étude, non enregistré ou hors indication dans les 30 jours avant la sélection ou utilisation prévue pendant toute la période de l’étude
    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
    DPV total à la visite du Mois 3, confirmé sur l’imagerie par échographie en mode B et l’imagerie SD-OCT (6 mm), d’après l’évaluation effectuée respectivement par l’expert en échographie en mode B en insu et le CIC en insu
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 3 visit
    Visite du Mois 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
    Principal critère d’évaluation de la tolérance :
    - Événement indésirable apparaissant sous traitement (EIAT) oculaire dans l’oeil à l’étude
    La tolérance sera également évaluée sur les paramètres suivants : EIAT déclarés, examen ophtalmologique complet, évaluation de la MAVC, évaluation de la vision des couleurs (sous-groupe), SD-OCT, ffERG (sous-groupe) et évaluation de l’immunogénicité.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From the time of providing consent until the end of the study.
    Du consentement éclairé écrit obtenu du patient jusqu'à la fin de l'étude
    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
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Czech Republic
    France
    Germany
    Italy
    Netherlands
    Poland
    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.
    La fin de l'étude est définie comme la dernière visite du dernier patient (DVDP) sauf si le comité de surveillance indépendant conseil une fin d'étude prematurée dû à la tolérance
    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 months10
    E.8.9.1In the Member State concerned days0
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    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)
    Standard of Care
    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 Decision2016-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-18
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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