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    Summary
    EudraCT Number:2016-005244-42
    Sponsor's Protocol Code Number:20159990
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-09-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-005244-42
    A.3Full title of the trial
    An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Rich Tumors of Bone
    DENOEUROSARC-007 - Etude de phase 2 multicentrique, en ouvert du denosumab chez des patients présentant des tumeurs osseuses riches en cellules géantes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Denosumab in patients with giant cell rich tumors of bone
    Du denosumab chez des patients présentant des tumeurs osseuses riches en cellules géantes
    A.3.2Name or abbreviated title of the trial where available
    DENOEUROSARC-007
    DENOEUROSARC-007
    A.4.1Sponsor's protocol code number20159990
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportFP7 EUROSARC
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointResearch secretary
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2300 RC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031071 526 1093
    B.5.6E-mailw.van_andel@lumc.nl
    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 Xgeva
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    Aneurysmal bone cysts, giant cell granuloma, other giant cell rich lesions
    (primary bone, non-malignant)
    kystes osseux anévrysmaux; granulome en cellules géantes, autres lésions riches en cellules géantes (osseuses primaires, non malignes)
    E.1.1.1Medical condition in easily understood language
    Aneurysmal bone cysts, giant cell granuloma, other benign giant cell rich lesions of bone
    kystes osseux anévrysmaux; granulome en cellules géantes, autres lésions riches osseuses non malignes à cellules géantes
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Subjects with salvageable giant cell rich tumors:
    - To evaluate subjects who do not require surgery during the study
    - To evaluate subjects who are able to undergo a less morbid surgical
    procedure compared with the planned surgical procedure at baseline
    during the study

    Subjects with unsalvageable giant cell rich tumors (combined objective):
    - To evaluate disease control:
    o Radiological response assessed by combined RECIST, PET, inverse Choi
    when available AND/OR
    o No progression at 1 year (based on disease assessment)
    - Stable pain score, defined as ≤ 1 point increase on 'worst pain'
    question in Brief Pain Inventory - short form (BPI-SF)
    Patients présentant une tumeur osseuse riche en cellules géantes accessible à la chirurgie :
    - Evaluer les patients qui ne nécessitent pas de chirurgie durant leur participation au projet
    - Evaluer les patients nécessitant une procédure chirurgicale moins invalidante que la procédure chirurgicale prévue à l’inclusion

    Patients présentant une tumeur osseuse riche en cellules géantes non accessible à la chirurgie (objectif combiné) :
    - Evaluer le contrôle de la maladie :
    o Réponse radiologique évaluée conjointement par les RECIST, le TEP et les critères de Choi modifiés si disponibles ET/OU
    o Absence de progression à 1 an (basée sur l’évaluation de la maladie)
    - Stabilité du score de la douleur, définie comme ≤ 1 point d’augmentation à la question « douleur la plus intense » du questionnaire BPI-SF (Brief Pain Inventory short form)
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of denosumab in subjects with
    giant cell rich tumors
    - To evaluate the proportion of recurrences after denosumab followed by
    surgery
    - To evaluate symptomatic improvement after denosumab in subjects
    with giant cell rich tumors
    - To evaluate time to surgery (for subjects with salvageable disease),
    time to recurrence after surgery, progression free survival
    - Evaluer la sécurité et la tolérance du Denosumab chez des patients présentant une tumeur osseuse riche en cellules géantes,
    - Evaluer le taux de rechutes après traitement par Denosumab suivi d’une chirurgie
    - Evaluer l’amélioration des symptômes après traitement par Denosumab chez des patients présentant une tumeur osseuse riche en cellules géantes
    - Evaluer le délai de recours à la chirurgie (pour les patients présentant une tumeur accessible à la chirurgie), le délai de rechute après chirurgie, la survie sans progression
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational research
    - Translational studies. Systematic analysis of pathologic and molecular
    markers on tumor material, including evaluation of pathological
    response for subjects undergoing surgery
    - Etudes translationnelles : Analyse systématique des marqueurs pathologiques et moléculaires sur le matériel tumoral, incluant l’évaluation du réarrangement de l’USP6 et la réponse pathologique pour les patients subissant une chirurgie.
    E.3Principal inclusion criteria
    The population will consist of patients with the following tumor types:
    - Pathologically proven giant cell rich tumor
    • ABC
    • GCG
    • Other giant cell rich lesions (primary bone, non-malignant, pathology
    and radiology to be reviewed during multidisciplinary meeting LUMC)
    - Patients with surgically unsalvageable disease (e.g., sacral, spinal giant cell rich tumors, or multiple lesions including pulmonary metastases) OR patients whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity
    - Measurable evidence of active disease within 1 year before study
    enrollment
    - Albumin-adjusted serum calcium level ≥ 2.0 mmol/L (8.0 mg/dL)
    - Aged 18 years and up and skeletally mature
    - ECOG performance status 0, 1 or 2
    - Written signed informed consent
    Diagnostic pathologique de tumeur osseuse riche en cellules géantes confirmé :
    o Kyste osseux anévrysmal (KOA)
    o Granulome à cellules géantes (GCG)
    o Autres lésions tumorales riches en cellules géantes (osseuses primaires, non malignes, revue centralisée durant une réunion multidisciplinaire LUMC des éléments radiologiques et pathologiques)
    - Patients avec une tumeur non accessible à la chirurgie (e.g. tumeurs sacrées, rachidiennes riches cellules géantes ou lésions multiples incluant des métastases pulmonaires) OU patients dont la chirurgie prévue inclut conjointement une résection de l’articulation, l’amputation d’un membre, une hémipelvectomie ou une procédure chirurgicale invalidante.
    - Maladie active mesurable dans l’année précédant l’inclusion dans l’étude
    - Calcémie corrigée (albumine) ≥ 2.0 mmol/L (8.0 mg/dL)
    - Agé de 18 ans ou plus et ayant un squelette mature
    - Indice de performance de l’ECOG (Eastern Cooperative Oncology Group) de 0, 1 ou 2
    - Consentement informé éclairé signé
    E.4Principal exclusion criteria
    - Known or suspected current diagnosis of classic GCTB
    - Known or suspected current diagnosis of underlying malignancy
    including but not limited to high-grade sarcoma, osteosarcoma,
    fibrosarcoma, malignant giant cell sarcoma
    - Known or suspected current diagnosis of brown cell tumor of
    hyperparathyroidism, Paget's disease or cherubism
    - Known or suspected current diagnosis of primary soft tissue tumor
    with invasion of the bone
    - Known diagnosis of other malignancy within the past 5 years (patients
    with definitively treated basal cell carcinoma and cervical carcinoma in
    situ are permitted)
    - Previous treatment with denosumab (with the exception of patients
    eligible for re-treatment with denosumab after completing this study)
    - Prior history or current evidence of osteonecrosis/osteomyelitis of the
    jaw
    - Active dental or jaw condition which requires oral surgery, including
    tooth extraction
    - Non-healed dental/oral surgery
    - Planned invasive dental procedure for the course of the study
    - Known hypersensitivity to denosumab
    - Known hypersensitivity to products to be administered during the
    study (calcium and/or vitamin D)
    - Currently receiving other specific treatment for giant cell rich tumors of
    bone (e.g., radiation, chemotherapy or embolization)
    - Concurrent bisphosphonate treatment
    - Major surgery less than 4 weeks prior to start of treatment
    - Treatment with other investigational device or drug 30 days prior to
    study enrollment
    - Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial
    infarction within 6 months before study enrollment
    - Patient is pregnant or breast feeding, or planning to become pregnant
    within 5 months after the EOT visit
    - Patient, or partner of patient, of child bearing potential is not willing to
    use a highly effective method of contraception (Cf. appendix D - Child-bearing potential and effective contraception) during treatment and for 5 months after the EOT visit
    - Patient has any kind of disorder that compromises the ability of the
    patient to give written informed consent and/or to comply with study
    procedures
    - Diagnostic connu ou suspecté de tumeur osseuse riche en cellules géantes classique
    - Diagnostic connu ou suspecté de tumeur maligne sous-jacente incluant mais ne se limitant pas à sarcome de haut grade, ostéosarcome, fibrosarcome, sarcome malin à cellules géantes
    - Diagnostic connu ou suspecté de tumeur de cellules brunes d’hyperparathyroïdie, maladie de Paget ou chérubisme
    - Diagnostic connu ou suspecté de tumeur primaire des tissus mous avec envahissement osseux
    - Diagnostic connu d’une autre tumeur maligne durant les 5 dernières années (les patients présentant un carcinome basocellulaire ou un carcinome cervical in situ peuvent être inclus)
    - Traitement antérieur par Denosumab (à l’exception des patients éligibles pour la reprise du traitement après la fin de l’étude)
    - Antécédents d’ostéonécrose / ostéomyélite de la mâchoire ou maladie en cours
    - Problème dentaire ou à la mâchoire nécessitant une chirurgie buccale, incluant les extractions dentaires
    - Chirurgie de la cavité buccale ou dentaire non cicatrisée
    - Procédure chirurgicale dentaire invasive planifiée durant l’étude
    - Hypersensibilité connue au Denosumab
    - Hypersensibilité connue aux produits qui seront administrés durant l’étude (calcium et/ou vitamine D)
    - Patient recevant un autre traitement pour la tumeur osseuse riche en cellules géantes (e.g., irradiation, chimiothérapie ou embolisation).
    - Traitement concomitant par bisphosphonate
    - Chirurgie majeure durant les 4 semaines précédant le début du traitement
    - Recours à un traitement ou un dispositif médical expérimental durant les 30 jours précédant l’inclusion dans l’étude
    - Maladie systémique non stable incluant : infection en cours, hypertension non contrôlée, angor instable, insuffisance cardiaque ou infarctus du myocarde dans les 6 mois précédent l’inclusion
    - Patiente enceinte ou allaitante, ou envisageant une grossesse dans les 5 mois suivant la visite de fin de traitement
    - Patient ou partenaire du patient en âge de procréer ne voulant pas utiliser une méthode de contraception hautement efficace (Cf. annexe D du protocole) durant la durée de l’étude et jusqu’à 5 mois après la visite de fin de traitement
    - Toute condition qui compromettrait l’aptitude du patient à donner son consentement éclairé signé et/ou à se conformer aux procédures de l’étude.
    E.5 End points
    E.5.1Primary end point(s)
    Subjects with salvageable giant cell rich tumors:
    - The proportion of subjects who do not require surgery during the study
    - The proportion of subjects undergoing the planned versus performed type of surgery during the study

    Subjects with unsalvageable giant cell rich tumors (combined endpoint):
    Disease control:
    - Radiological response assessed by combined RECIST, PET, inverse Choi when available AND/OR
    - No progression at 1 year (based on disease assessment)
    - Stable pain score, defined as ≤ 1 point increase on 'worst pain' question in BPI-SF
    Patients présentant une tumeur osseuse riche en cellules géantes accessible à la chirurgie :
    - Taux de patients ne nécessitant pas le recours à une chirurgie durant l’étude,
    - Taux de patients ayant bénéficié de la procédure chirurgicale prévue versus la procédure réalisée durant l’étude.

    Patients présentant une tumeur riche en cellules géantes non accessible à la chirurgie :
    - Contrôle de la maladie :
    o Réponse radiologique évaluée d’après les RECIST, le TEP et les critères de Choi modifiés si disponibles ET/OU
    o absence de progression à 1 an (basée sur l’évaluation de la maladie)
    - Stabilité du score de la douleur, définie comme l’augmentation ≤ 1 point d’augmentation à la question « douleur maximale » du questionnaire BPI-SF
    E.5.1.1Timepoint(s) of evaluation of this end point
    - evaluation during whole length of study
    - imaging every 12 weeks, evaluation at 1 year
    - questionnaire every 4 weeks, evaluation at 1 year
    - questionnaire every 4 weeks, evaluation at 1 year
    - évaluation tout au long de l'étude
    - imagerie toutes les 12 semaines, évaluation à 1 an
    - questionnaire toutes les 4 semaines, évaluation à 1 an
    E.5.2Secondary end point(s)
    - Frequency of adverse events (AEs), as determined by Common Terminology Criteria for Adverse Events (CTCAE) v. 4.03 criteria
    - The proportion of subjects with disease recurrence after denosumab followed by surgery during the study
    - Symptomatic improvement in the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire C30 (EORTC QLC-30) / BPI-SF, including:
    - Change from baseline at 1 year, and
    - Time to improvement in pain and time to worsening of pain
    - Time to surgery (for subjects with salvageable disease), time to recurrence after surgery, progression free survival
    - Fréquence des événements indésirables (EIs), tels que définis par les critères du « Common Terminology Criteria for Adverse Events » (CTCAE) v. 4.03.
    - Taux de patients présentant une rechute après traitement par Dénosumab suivi d’une chirurgie réalisée durant la participation à l’étude
    - Amélioration des symptômes d’après les questionnaires de qualité de vie EORTC (European Organization for Research and Treatment of Cancer) QLC-30 et BPI-SF, incluant :
    - Changement entre l’inclusion et 1 an,
    - Délai de réduction de la douleur et délai d’augmentation de la douleur
    - Délai de recours à la chirurgie (pour les patients présentant une tumeur accessible à la chirurgie), délai de rechute après chirurgie, survie sans progression.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - AE registration every 4 weeks, evaluation after 1 year
    - evaluation during whole length of study
    - questionnaire every 4 weeks, evaluation at 1 year
    - enregistrement des événements indésirables toutes les 4 semaines, évaluation à 1 an
    - évaluation tout au long de l'étude
    - questionnaire toutes les 4 semaines, évaluation à 1 an
    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 Yes
    E.6.13.1Other scope of the trial description
    Translational research
    - Pathologic and molecular markers on tumor material
    - Evaluation / proportion of subjects with pathological response for
    subjects undergoing surgery
    Etudes translationnelles
    - Marqueurs pathologiques et moléculaires sur le matériel tumoral
    - Evaluation / Proportion d'une réponse pathologique pour les patients subissant une chirurgie.
    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 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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLP
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    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: 55
    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 No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Subjects will complete safety follow-up visits after denosumab is stopped every 6 months (± 1 month) for the 1st year and then every 12 months (± 1 month) thereafter until the end of study. Subjects will be asked about SAE's, AEs of interest and disease treatments and outcomes.
    AEs of special interest include :
    • Osteonecrosis of the jaw
    • Malignancy, including malignancy in their giant cell rich tumor of bone
    • Atypical femoral fracture
    Les patients effectueront la 1ère année des visites de suivi après l’arrêt du denosumab tous les 6 mois (± 1 mois), puis tous les 12 mois (± 1 mois) jusqu’à la fin de l’étude. Les patients seront interrogés sur les événements indésirables graves, les effets indésirables, les traitements et les effets de la maladie.
    Les EI présentant un intérêt spécial :
    • ostéonécrose de la mâchoire
    • Tumeur maligne, y compris une tumeur maligne osseuse riche en cellules géantes
    • fracture fémorale atypique
    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 Decision2019-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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