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    Summary
    EudraCT Number:2018-004054-24
    Sponsor's Protocol Code Number:PHRCN2017/CAPRI-MARIE/NK
    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:2019-02-01
    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 number2018-004054-24
    A.3Full title of the trial
    Assessment of the (18)F-florbetaben whole-body PET imaging diagnostic performance for the detection of cardiac and extracardiac sites of amyloid deposits in patients with amyloidosis
    Evaluation de la performance diagnostique de l’examen TEP/TDM corps entier au 18F-Florbetaben pour la détection des dépôts amyloïdes aux niveaux cardiaque et extracardiaque chez des patients atteints d’amylose cardiaque
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of (18)F-florbetaben whole-body PET for the detection of cardiac and extracardiac sites of amyloid deposits
    Evaluation de l’examen TEP corps entier au (18)F-Florbetaben pour la détection des dépôts amyloïdes cardiaques et extracardiaques
    A.3.2Name or abbreviated title of the trial where available
    CAPRI
    CAPRI
    A.4.1Sponsor's protocol code numberPHRCN2017/CAPRI-MARIE/NK
    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 SponsorCentre Hospitalier Régional Universitaire de Nancy
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Régional Universitaire de Nancy
    B.5.2Functional name of contact pointChef de projets
    B.5.3 Address:
    B.5.3.1Street AddressRue du Morvan
    B.5.3.2Town/ cityVANDOEUVRE-LES-NANCY
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.4Telephone number00 333 83 15 52 79
    B.5.5Fax number00 33383 15 74 51
    B.5.6E-maildripromoteur@chru-nancy.fr
    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 NEURACEQ 300 MBq/ml solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderLife Radiopharma Berlin GmbH
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLORBETABEN (18F)
    D.3.9.1CAS number 902143-01-5
    D.3.9.2Current sponsor codeFLORBETABEN (18F)
    D.3.9.3Other descriptive nameFLORBETABEN (18F)
    D.3.9.4EV Substance CodeSUB119774
    D.3.10 Strength
    D.3.10.1Concentration unit Bq/kg becquerel(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number240 to 360
    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 Yes
    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
    cardiac amyloidosis
    amylose cardiaque
    E.1.1.1Medical condition in easily understood language
    cardiac amyloidosis
    amylose cardiaque
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007509
    E.1.2Term Cardiac amyloidosis
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the diagnostic performance of whole-body (18)F-florbetaben PET/CT recordings, in identifying AL- or ATTR-types of cardiac amyloidosis compared with a control population with cardiac hypertrophy not related to cardiac amyloidosis, by using measurements of cardiac activity with Standardized Uptake Values (SUV) and TBR (TBR: Target-to-Background Ratio, ratio = measured activities /.blood activity)
    Evaluer la performance diagnostique de la TEP/TDM corps entier au 18F-Florbetaben enregistrée sur des images conventionnelles corps entier pour identifier les amyloses avérées de type AL ou ATTR par comparaison à une population contrôle présentant une hypertrophie cardiaque non liée à l’amylose à l’aide de mesures de SUV (Standardized Uptake Values) et TBR (Target to Background Ratio = rapport des activités mesurées sur l’activité sanguine circulante).
    E.2.2Secondary objectives of the trial
    1. To assess the diagnostic performance of whole-body PET/CT recordings, as reported in the main objective, to identify AL and ATTR amyloidosis individually
    2. To determine whether (18)F-florbetaben whole-body PET/CT images can reveal extracardiac areas with increased activity in AL and/or ATTR groups, when compared to the control population, particularly in areas easily accessible to biopsy sampling
    3. To compare the cardiac kinetics of (18)F-florbetaben, within the first hour following injection, between patients with cardiac amyloidosis and the control population
    4. To determine whether most patients with true-positive MRI for cardiac amyloidosis and those with positive bone scintigraphy with regard to the diagnosis of cardiac amyloidosis are also positive with whole-body (18)F-florbetaben PET/CT for this diagnosis.
    5.To assess the intra- and inter-observer agreements for the analysis of (18)F-florbetaben whole-body PET/CT images.
    1. Evaluer la performance diagnostique de la TEP/TDM corps entier au 18F-Florbetaben, telles que décrites dans l’objectif principal, mais pour identifier les formes d’amylose AL et ATTR individuellement
    2. Déterminer si la TEP/TDM corps entier au 18F-Florbetaben permet de révéler des zones extracardiaques ayant une fixation augmentée dans les groupes AL et/ou ATTR, par rapport à la population contrôle, en particulier dans les zones facilement accessibles à des prélèvements biopsiques
    3. Comparer la cinétique de fixation cardiaque du 18F-Florbetaben, entre les patients ayant une AC et les sujets contrôles, dans l’heure suivant l'injection
    4. Déterminer si la plupart des patients ayant une IRM positive pour l’AC et la plupart de ceux ayant une scintigraphie osseuse elle aussi positive au niveau cardiaque, ont également un examen TEP/TDM au 18F-Florbetaben positif
    5. Estimer le degré de reproductibilité intra et inter observateur pour l’analyse des examens TEP/TDM au 18F-Florbetaben.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For all amyloidosis patients and for control subjects
    -person over the age of majority
    -person informed about study organization and having signed the informed consent
    -person affiliated to or beneficiary of a social security plan

    For ATTR amyloidosis patients:
    -left ventricular concentric hypertrophy with a diastolic septal thickness ≥ 15 mm at echocardiography* within the last two months
    -Bone scan with moderate to significant cardiac uptake (clear positive result for a cardiac amyloidosis diagnosis) and/or transthyretin-reactive antibodies at pathology of cardiac or extracardiac sites.

    For AL amyloidosis patients:
    -left ventricular concentric hypertrophy with a diastolic septal thickness ≥ 13 mm at echocardiography* within the last two months ,
    -significant cardiac disease evidenced by an increase in plasma NT-ProBNP (or BNP) and/or in troponin T (or I), corresponding to a Mayo clinic score ≥ 2 (J Clin Oncol. 2012; 30(9):989-95),
    -κ or λ immunoglobulin light chain-reactive antibodies at pathology of cardiac or extracardiac sites.

    For control subjects:
    -history of surgical or TAVI treatment of aortic stenosis,
    -matching with an amyloidosis patient according to gender and age (± 5 years),
    -cardiac hypertrophy with a diastolic septal thickness ≥ 15 mm at echocardiography when matching with an ATTR patient and ≥ 13 mm when matching with an AL patient.

    *according to the current distribution of this parameter in the ATTR patients involved in the national cohort of the Henri Mondor Hospital.
    Pour tous les patients atteints d’amylose cardiaque et les sujets contrôles :
    -Personne majeure
    -Personne ayant reçu l’information complète sur l’organisation de la recherche et ayant signé son consentement éclairé
    -Personne affiliée à un régime de sécurité sociale ou bénéficiaire d’un tel régime

    Critères d’inclusion spécifiques au groupe amylose ATTR:
    -Hypertrophie ventriculaire gauche concentrique* avec une épaisseur septale en diastole ≥ 15 mm à l’échocardiographie de moins de deux mois.
    -Scintigraphie osseuse avec fixation cardiaque modérée à importante (clairement positive pour un diagnostic d’amylose cardiaque) et/ou présence d’anticorps spécifiques à l’amylose ATTR sur des prélèvements provenant de sites cardiaques ou extracardiaques.

    Critères d’inclusion spécifiques au groupe amylose AL:
    -Hypertrophie ventriculaire gauche concentrique* avec une épaisseur septale en diastole ≥ 13 mm à l’échocardiographie de moins de deux mois.
    -Retentissement cardiaque significatif mis en évidence par une augmentation du taux de NT-ProBNP (ou BNP) plasmatique et/ou de la troponine T (ou I), correspondant à un score clinique Mayo ≥ 2 (J Clin Oncol. 2012; 30(9):989-95).
    -Présence de chaines légères d’immunoglobulines κ ou λ au niveau des prélèvements provenant de sites cardiaques ou extracardiaques.

    Critères d’inclusion spécifiques au groupe contrôle:
    -Antécédents de traitement chirurgical ou TAVI d’un rétrécissement aortique
    -Appariement avec un patient atteint d'amylose de même sexe et de même âge (± 5 ans)
    -Hypertrophie cardiaque avec une épaisseur septale en diastole ≥ 15 mm à l'échocardiographie de moins de 2 mois en cas d'appariement avec un patient ATTR et ≥ 13 mm en cas d'appariement avec un patient AL

    *telle que définie chez les patients ATTR impliqués dans une cohorte nationale française de l'Hôpital Henri Mondor.
    E.4Principal exclusion criteria
    For all amyloidosis patients and control subjects
    -Known allergy to the active substance and to any excipient for (18)F-florbetaben
    -Known allergy to the bone scintigraphy radiotracer (99mTc-HDP)
    -Pregnant, parturient or breastfeeding woman
    -Woman of childbearing age without effective contraception (progestogen or estrogen / progesterone) or intrauterine contraception, or who has not undergone sterilization
    -Person in the process of alcohol withdrawal or a chronic alcoholic intoxication
    -Severe hepatic insufficiency according to clinical evaluation (ascites, jaundice and / or encephalopathy).
    -Dialysis person
    -Major person under legal protection (any form of public guardianship)
    -Major person unable to express consent
    -Person deprived of liberty due to judicial or administrative decision.
    -Person subject to psychiatric care under Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
    -Impossibility of performing (18)F-florbetaben PET (agitated, confused patient, etc.).
    -Severe left ventricular dysfunction with an ejection fraction ≤ 35%.
    -No obvious cause of cardiac disease except for the aortic stenosis (for the control subjects) or except for the cardiac amyloidosis (for the amyloidosis patients).

    For control patients only :
    -monoclonal gammopathy on a previous protein electrophoresis or
    -bone scan with moderate to significant cardiac uptake (clear positive result for a cardiac amyloidosis diagnosis) on a previous bone scintigraphy (this criterium is being additionally a cause of secondary exclusion when documented on the bone scintigraphy included in the study protocol).
    Pour tous les patients et sujets contrôles :
    - Allergie connue à la substance active et à tout excipient du 18F-Florbetaben
    -Allergie connue au radiotraceur de scintigraphie osseuse (99mTc-HDP)
    -Femme enceinte, parturiente ou mère qui allaite
    -Femme en âge de procréer n’ayant ni contraception hormonale (progestative ou oestroprogestative) ni contraception intra-utérine, ou n’ayant pas subi une méthode de stérilisation
    -Personne en cours de sevrage alcoolique ou intoxication alcoolique chronique
    -Insuffisance hépatique sévère selon évaluation clinique (ascite, ictère et /ou encéphalopathie)
    -Personne dialysée
    -Personne majeure faisant l'objet d'une mesure de protection légale (tutelle, curatelle, sauvegarde de justice)
    -Personne majeure hors d'état d'exprimer son consentement
    -Personne privée de liberté par une décision judiciaire ou administrative
    -Personne faisant l'objet de soins psychiatriques en vertu des articles L. 3212-1 et L. 3213-1
    -Aucune cause évidente de maladie cardiaque, à l'exception du rétrécissement aortique pour les contrôles et à l’exception de l’amylose cardiaque chez les patients atteints d’amylose.
    -Impossibilité de réaliser une TEP/TDM au 18F-florbetaben (patient agité, confus, ou autres)
    -Sévère dysfonction du ventricule gauche avec fraction d’éjection ≤ 35%

    Critères de non-inclusion spécifiques au groupe contrôle:
    -gammapathie monoclonale sur une précédente électrophorèse ou,
    -une fixation cardiaque d’intensité modérée à importante (clairement positive pour un diagnostic d’amylose cardiaque) sur une précédente scintigraphie osseuse (ce critère est en outre une cause d'exclusion secondaire lorsqu'il est documenté sur la scintigraphie réalisée dans le cadre de la recherche)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of positive ATTR or AL cardiac amyloidosis diagnoses shown in 18F-Florbetaben PET / CT in patients with cardiac amyloidosis diagnosed using the criteria described in the inclusion criteria.). A « control » population, including patients with left ventricular hypertrophy definitively unrelated to amyloidosis (even for low to mild forms) will be added for the analysis (this hypertrophy is mandatory for reaching a partial volume effect comparable to that found in amyloidosis patients when recording myocardial PET activity).
    Pourcentage de diagnostics positifs d'amylose cardiaque ATTR ou AL révélés en TEP/TDM au 18F-Florbetaben dans la population de patients atteints d’amylose cardiaque diagnostiquée en utilisant les critères décrits dans les critères d’inclusion.
    Une population témoin, incluant les patients présentant une hypertrophie ventriculaire gauche définitivement non liée à l'amylose (même pour les formes faibles à légères), sera incluse pour l'analyse (cette hypertrophie est nécessaire pour atteindre un effet de volume partiel comparable à celui des patients atteints d’amylose lors des mesures de l'activité myocardique en TEP).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Upon 24 months
    E.5.2Secondary end point(s)
    1. Identical to the primary endpoint, except that the analyses will be planned separately for AL and ATTR amyloidosis.

    2. Areas of abnormal (18)F-florbetaben uptake will be studied on whole-body PET/CT images, especially in the extracardiac sites that are the most likely to present amyloid deposits, and particularly those most accessible to biopsy sampling (tongue, rectum, submandibular glands, carpal tunnel, liver, thyroid and subcutaneous tissues etc.). These uptakes will be quantified with SUV and TBR values obtained from extracardiac sites and defined as pathological if they are significantly superior to the measurements made in the same areas in control subjects.

    3. Comparative analysis of the evolution of myocardial SUV and TBR values and of a myocardial retention index all throughout the 60-min post-injection period in patients and controls.

    4. The rates of (18)F-florbetaben whole-body PET/CT deemed positive for cardiac amyloidosis will be specifically determined in patients with positive bone scintigraphy (≥ mild cardiac uptake (3)) and/or a positive MRI (delayed retention imaging with decreased myocardial T1 (5, 6)).

    5. Intra-observer and inter-observer reproducibility measurements of SUV and TBR values obtained at cardiac and extracardiac sites from whole-body PET / CT images of 20 patients with amyloidosis (10 with Type AL and 10 with an ATTR type)
    1. Identique au critère d’évaluation principal, mais les analyses seront alors effectuées séparément chez les patients atteints d’amylose AL et ATTR.
    2. Les zones de fixation anormale du 18F-Florbetaben seront étudiées sur l’examen TEP corps entier, en particulier au niveau des sites extracardiaques les plus susceptibles de présenter des dépôts amyloïdes et ceux étant les plus accessibles à des prélèvements biopsiques (langue, rectum, glandes sous-maxillaires, canal carpien, foie, thyroïde et tissus sous-cutanés, etc.). Ces fixations seront quantifiées en mesurant les SUV et TBR des sites extra-cardiaques considérés et elles seront définies comme pathologiques si elles s’avèrent significativement supérieures aux mesures effectuées dans les mêmes régions chez les sujets témoins.
    3. Analyse comparative entre les patients et les sujets contrôles de l’évolution sur les 60 minutes suivant l’injection des valeurs de SUV et TBR myocardiques et d’un indice de rétention myocardique du traceur.
    4. Taux d’examens TEP/TDM au 18F-Florbetaben positifs chez les patients ayant une scintigraphie osseuse positive (≥ fixation cardiaque légère) et/ou chez les patients ayant une IRM positive (rétention tardive typique avec baisse du T1 myocardique).
    5. Mesures des reproductibilités intra-observateur et inter-observateur des valeurs de SUV et de TBR obtenues sur les sites cardiaque et extracardiaques à partir des images corps entier de TEP/TDM de 20 patients atteints d'amylose (10 avec Type AL et 10 avec un type ATTR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Upon 24 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 No
    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
    last visite of last patient + 4 months for data analysis
    dernière visite du dernier patient + 4 mois pour analyses statistiques
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months28
    E.8.9.1In the Member State concerned days
    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: 59
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 59
    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 state118
    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
    Aucun
    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 Decision2019-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
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