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    Summary
    EudraCT Number:2020-003154-80
    Sponsor's Protocol Code Number:2020CLI
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-003154-80
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Mechanism of Action of an Oral Enzyme Treatment with Bromelain, Trypsin and Rutoside versus Placebo in Subjects with OsTeoarthritis (WOBE-SMART)
    Étude Randomisée, en Double-Aveugle, Contrôlée avec un Placebo, Croisée qui Investigue le Mécanisme d’Action d’un Traitement Oral Enzymatique avec de la Broméline, de la Trypsine et du Rutoside versus Placebo chez des sujets atteints d’Arthrose (WOBE-SMART).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the mechanism of action of a medicinal product based on Bromelain, Trypsin and Rutoside, compared to the same medicinal product without active ingredient called Placebo in subjects suffering from osteoarthritis.
    Étude du mécanisme d'action d'un médicament à base de Broméline, de Trypsine et de Rutoside, comparé au même médicament sans ingrédient actif appelé Placebo chez des sujets souffrant d'arthrose.
    A.3.2Name or abbreviated title of the trial where available
    WOBE-SMART study
    Étude WOBE-SMART
    A.4.1Sponsor's protocol code number2020CLI
    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 SponsorMucos Pharma GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportMucos Pharma GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArtialis SA
    B.5.2Functional name of contact pointArtialis
    B.5.3 Address:
    B.5.3.1Street Address11, Avenue de l'Hôpital, B34 (+3)
    B.5.3.2Town/ cityLiège
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.6E-mailinvestigators_clinicaltrials@artialis.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 WOBENZYM®, enteric-coated tablet
    D.2.1.1.2Name of the Marketing Authorisation holderMucos Pharma GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameWobenzym
    D.3.4Pharmaceutical form Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBromelains
    D.3.9.1CAS number 37189-34-7
    D.3.9.3Other descriptive nameBromelain
    D.3.9.4EV Substance CodeSUB22009
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number67.5 to 76.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrypsin
    D.3.9.1CAS number 9002-07-7
    D.3.9.4EV Substance CodeSUB12616MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number32 to 48
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRutoside trihydrate
    D.3.9.1CAS number 250249-75-3
    D.3.9.4EV Substance CodeSUB30642
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGastro-resistant tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects suffering from knee Osteoarthitis
    Sujets souffrant d'Arthrose du genou
    E.1.1.1Medical condition in easily understood language
    Subjects suffering from knee osteoarthritis
    Sujets souffrant d'arthrose du genou
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031161
    E.1.2Term Osteoarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the pharmacodynamic profile of an oral enzyme treatment with Bromelain, Trypsin and Rutoside in subjects with Osteoarthritis.
    L'objectif principal de cette étude est d'évaluer le profil pharmacodynamique d'un traitement enzymatique oral à base de Broméline, de Trypsine et de Rutoside chez des sujets atteints d'Arthrose.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate:

    • Vital signs and anthropomorphic measurements;
    • Knee pain;
    • Knee function;
    • Patient global assessment of disease activity (PGADA);
    • Patient physical activity;
    • Body metabolism;
    • Clinical chemistry;
    • Joint structure modification;
    • Volume of joint effusion;
    • Tolerance;
    • Compliance;
    • Responder to treatment.
    Les objectifs secondaires sont d'évaluer :
    • Les signes vitaux et les mesures anthropomorphiques ;
    • La douleur du genou ;
    • La fonction du genou ;
    • L’appréciation globale du patient de l’activité de la maladie (son impact); ;
    • L’activité physique du patient ;
    • Le métabolisme corporel ;
    • La chimie clinique ;
    • La modification de la structure de l’articulation ;
    • Le volume d'épanchement articulaire ;
    • La tolérance ;
    • L’observance ;
    • Le taux de répondeurs au traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
    1. Male or female ≥ 40 years of age and with BMI ≤ 35 kg/m2;
    2. Uni- or bilateral femorotibial knee OA :
    a. Responding to clinical and radiological criteria of American College of Rheumatology (ACR);
    b. Symptomatic for more than 6 months in the index knee;
    c. Radiological Kellgren & Lawrence (K&L) grade II-III in standing x-rays from less than 12 months.
    3. Mild-to-Moderate mean knee pain score at rest or at walking over the last 24 hours on the index knee evaluated on VAS (0-100) ≥ 40 at baseline;
    4. Able to follow the instructions of the study;
    5. Having signed an informed consent.
    Les sujets doivent répondre à TOUS les critères suivants :
    1. Homme ou femme âgé(e) de ≥ 40 avec un IMC ≤ 35 kg/m2;
    2. Arthrose fémoro-tibiale du genou uni ou bilatérale :
    a. Répondant aux critères cliniques et radiologiques du Collège Américain de Rhumatologie (ACR) ;
    b. Symptomatique depuis plus de 6 mois sur le genou cible ;
    c. Grade radiologique de Kellgren et Lawrence (K&L) de II-III sur base d’une radio datant de moins de 12 mois ;
    3. Score de douleur du genou, faible à modéré, évalué sur une EVA (0-100) ≥ 40 au repos ou à la marche au cours des 24 dernières heures précédant la visite d’inclusion ;
    4. En mesure de suivre les instructions de l’étude ;
    5. Ayant signé un formulaire de consentement.
    E.4Principal exclusion criteria
    Subjects that meet AT LEAST one of the following criteria will be excluded:

    Related to knee:
    1. Recent macro-trauma of the knee responsible of the symptomatic knee left to the Investigator’s discretion;
    2. Concurrent articular disease interfering with the evaluation of pain left to the Investigator’s discretion;
    3. Prosthesis in the target knee;
    4. Knee swelling requiring corticosteroids local injection.

    Related to treatments:
    5. Analgesics to manage knee pain 24 hours before randomization visit;
    6. Corticosteroids injection in the target knee in the last 3 months;
    7. Hyaluronan injection in the target knee in the last 6 months;
    8. Arthroscopy in the last 6 months;
    9. Oral corticotherapy ≥ 5mg/day (in Prednisolone equivalent) in the last 3 months;
    10. Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) or dietary supplement, i.e., curcuma extract, chondroitin, glucosamine, diacerein or avocado-soya unsaponifiables in the last 3 months;
    11. An anticipated need for any forbidden treatments during the trial;
    12. Contraindications to the product :
    a. severe hepatic and renal impairment;
    b. congenital or acquired coagulation disorders, e.g. haemophilia;
    c. severe liver and/or kidney damage;
    d. hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
    13. Hypersensitivity or allergy to the product components or pineapple;
    14. Treatments based on strontium ranelate, bisphosphonates, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months;
    15. Treatment based on zoledronate in the last 2 years;
    16. Treatment based on denosumab in the last 6 months;
    17. Treatment with anticoagulants and/or anti-platelet agents, except patients on 100 mg low dose Aspirin that have no identifiable risk of bleeding in their medical history upon discretion of the PI.

    Related to associated diseases:
    18. Any severe, uncontrolled and limiting disease left to the Investigator’s
    discretion;
    19. Patient with widespread pain/depression (e.g. fibromyalgia);
    20. Lower or upper extremity surgery or fracture in the last 6 months;
    21. Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee;
    22. Severe alteration of mobility enabling functional evaluation.

    Related to subjects:
    23. Close collaborators to the investigational team, the study coordinator (ARTIALIS) or to the Sponsor;
    24. Currently participating or having participated in another therapeutic clinical trial in the 3 previous months;
    25. Having made a blood donation in the past month;
    26. Under guardianship or judicial protection;
    27. Pregnancy, breastfeeding, planned conception, or premenopausal women without effective contraception (tablet, patch, ring, diaphragm, implant and intrauterine device, tubal ligation or hysterectomy);
    28. Counter-indication to an MRI examination.
    Les sujets répondant à au moins un des critères suivants seront exclus :

    Concernant le genou :
    1. Récent macro traumatisme du genou responsable de la symptomatologie du genou laissé à l’appréciation de l’Investigateur ;
    2. Maladie articulaire concomitante pouvant interférer avec l’évaluation de la douleur du genou laissé à l’appréciation de l’Investigateur ;
    3. Prothèse dans le genou cible ;
    4. Gonflement du genou nécessitant des injections locales de corticostéroïdes.

    Concernant les traitements :
    5. Analgésiques pour gérer la douleur du genou 24 heures avant la visite de randomisation ;
    6. Injection de corticostéroïdes dans le genou cible dans les 3 derniers mois ;
    7. Injection d’acide hyaluronique dans le genou cible dans les 6 derniers mois ;
    8. Arthroscopie dans les 6 derniers mois ;
    9. Corticothérapie orale ≥ 5mg/jour (équivalent au Prednisolone) dans les 3 derniers mois ;
    10. Anti-arthrosiques d'action lente (AASAL) ou complément alimentaire de type extrait de curcuma, chondroïtine, glucosamine, diacérine ou insaponifiables de soja et d'avocats dans les 3 derniers mois ;
    11. Besoin anticipé d’un traitement interdit au cours de l’étude ;
    12. Contre-indications liées au produit :
    a. insuffisance hépatique et rénale sévère ;
    b. troubles congénitaux ou acquis de la coagulation, par ex. hémophilie ;
    c. lésions hépatiques et/ou rénales sévères ;
    d. intolérance héréditaire au galactose, déficit en lactase Lapp ou malabsorption du glucose-galactose.
    13. Hypersensibilité ou allergie aux composants du produit et à l’ananas ;
    14. Traitements à base de ranélate de strontium, bisphosphonates, modulateurs sélectifs des récepteurs aux Oestrogènes (SERM) et parathormone (PTH) dans les 12 derniers mois ;
    15. Traitement à base de zoledronate dans les 2 derrières années ;
    16. Traitement à base de denosumab dans les 6 derniers mois ;
    17. Traitement avec des agents anticoagulants et/ou antiplaquettaires, exceptés les patients sous 100 mg d'aspirine à faible dose qui n'ont pas de risque de saignement identifiable dans leurs antécédents médicaux à la discrétion de l'Investigateur.

    Concernant les pathologies associées :
    18. Toute maladie sévère, non-contrôlée et limitante, laissée à l’appréciation de l’Investigateur ;
    19. Patient souffrant de dépression ou de douleurs généralisées (fibromyalgie, par exemple) ;
    20. Chirurgie ou fracture des membres inférieurs ou supérieurs dans les 6 derniers mois ;
    21. Prévision d'une chirurgie ou de toute autre procédure invasive pendant l'étude, incluant la pose d'une prothèse sur le genou cible ;
    22. Altération sévère de la mobilité empêchant l’évaluation fonctionnelle.

    Concernant les patients :
    23. Proches collaborateurs de l’équipe d’investigation, du coordinateur de l’étude (ARTIALIS) ou du Sponsor ;
    24. Participant actuellement ou ayant participé à une autre étude clinique thérapeutique dans les 3 derniers mois ;
    25. Don de sang réalisé dans le mois précédent ;
    26. Sous tutelle ou protection judiciaire ;
    27. Femme enceinte, allaitante, qui prévoit une grossesse ou femme non-ménopausée sans contraception efficace (pilule, patch, anneau, diaphragme, implant ou dispositif intra-utérin, ligature des trompes ou hystérectomie) ;
    28. Contre-indications pour les examens IRM.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints for evaluation of the pharmacodynamic profile are:
    • Effects on cartilage biomarkers using immunoassays;
    • Effects on markers of innate immune response;
    • Effects on systemic inflammatory markers using immunoassays;
    • Effects on cellular pathways identified by changes in proteomic profile.
    Les mesures principales pour évaluer le profil pharmacodynamique sont :
    • les effets sur les biomarqueurs du cartilage par immunoessais ;
    • les effets sur les biomarqueurs de la réponse immunitaire innée ;
    • les effets sur les marqueurs de l’inflammation systémiques par immunoessais ;
    • les effets sur les voies cellulaires identifiées par des changements de profiles protéomiques.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At four timepoints for the entire treatment period (cross-over design, 2 parallel arms):

    During the first treatment period:
    - at V0 (baseline)
    - at V2 (8 weeks post-baseline)

    During the second treatment period:
    - at V3 (12 weeks post-baseline and including 4 weeks wash out)
    - at V5 (20 weeks post-baseline)
    À quatre moments sur l'ensemble de la période de traitement (étude cross-over, à 2 bras parallèles) :

    Durant la première période de traitement :
    - à V0 (ligne de base)
    - à V2 (8 semaines après la ligne de base)

    Durant la deuxième période de traitement :
    - à V3 (12 semaines après la ligne de base, incluant 4 semaines de lavage)
    - à V5 (20 semaines après la ligne de base)
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • Blood Pressure (BP), Heart Rate (HR), Temperature, Weight, Height and
    BMI;
    • Knee pain at rest and while walking using a Visual Analogue Scale (VAS);
    • Global score and each of the five subscales scores of the Knee Injury and
    Osteoarthritis Outcome Score (KOOS) using a self-administered
    questionnaire;
    • PGADA using a VAS;
    • Global physical activity using a connected device;
    • Concentration of growth factors in serum (e.g. TGF-β1_β2_β3) using
    immunoassays;
    • Clinical chemistry measurements using immunoassays:
    - Concentration of myokines (e.g. myostatin);
    - Concentration of hemoglobin, hematocrit, erythrocyte count, Triglyceride (TG), Total cholesterol (TC), LDL, HDL, glucose, hsCRP, uric acid, coagulation markers and key hepatic enzymes;
    • Semi-quantitative joint assessment of knee OA features using MOAKS (MRI
    Osteoarthritis Knee Score) or WORMS (Whole-Organ Magnetic Resonance
    Imaging Score);
    • Volume of joint effusion by magnetic resonance imaging (MRI);
    • Adverse Events (AE) and drop out;
    • Tablet count;
    • Responder rate to treatment defined as changes in knee pain and/or knee
    function and/or subjects disease activity according to OMERACT OARSI
    criteria.
    Les mesures secondaires sont :
    • La Tension Artérielle (TA), Rythme Cardiaque (RC), Température, Poids, Taille et Indice de Masse Corporel (IMC) ;
    • La douleur du genou au repos et à la marche au moyen d’une Echelle Visuelle Analogique (EVA);
    • Le score global et chacun des 5 sous-scores des différentes catégories du
    questionnaire auto-administré KOOS (Knee Injury and Osteoarthritis
    Outcome Score) ;
    • L’appréciation globale du patient de l’activité de la maladie au moyen d’une EVA ;
    • L’activité physique globale en utilisant une montre connectée ;
    • La concentration des facteurs de croissance (TGF-β1_β2_β3) dans le sérum par immunoessais ;
    • Les mesures de chimie clinique par immunoessais :
    - Concentration des myokines (ex : myostatine) ;
    - Concentration de l’hémoglobine, l’hématocrite, le compte d’érythrocytes, Triglycéride (TG), Cholestérol Total (TC), LDL, HDL, glucose, hsCRP, acide urique, les marqueurs de coagulation et les enzymes hépatiques majeures ;
    • L’évaluation semi-quantitative de l’articulation de l’athrose du genou en utilisant les scores IRM : MOAKS (MRI Osteoarthritis Knee Score) ou WORMS (Whole-Organ Magnetic Resonance Imaging Score) ;
    • Le volume d'épanchement articulaire évalué par imagerie par résonance magnétique (IRM) ;
    • L’enregistrement des Evènements Indésirables (EI)/Evènements Indésirables Graves (EIG) et des sorties d’étude ;
    • Le comptage des comprimés restants ;
    • Le taux de répondeurs au traitement qui est défini comme les changements au niveau de la douleur et/ou de la fonction du genou et/ou l’activité de la maladie du patient, et qui sera évalué au moyen des critères OMERACT-OARSI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    To be evaluated at each visit except:

    - Immunoassays and clinical chemistry which are evaluated at two timepoints for each treatment period (V0, V2 and V3, V5);
    - MRI which is evaluated at two timepoints for the second treatment period only (assessment at V3 for all subjects and at V6 only for subjects who have an end of study at V6).
    A évaluer à chaque visite sauf :
    - les tests immunologiques et la chimie clinique qui sont évalués à deux moments de chaque période de traitement (V0, V2 et V3, V5) ;
    - les IRM qui sont évaluées à deux moments de la seconde période de traitement
    seulement (évaluation à V3 pour tous les sujets et à V6 uniquement pour les sujets ayant une fin d'étude à V6).
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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
    Exploratory Objectives:
    • Optional (on a voluntary basis): Gut microbiome and metabolome profiling;
    • Optional (based on site capacity): Patient physical performance;
    • Inflammatory biomarker immunoassay.
    Objectifs exploratoires :
    • Facultatif (sur base volontaire) : Le profil microbiomique et métabolomique intestinal ;
    • Facultatif (en fonction de la capacité du site) : La performance physique du patient ;
    • Biomarqueur inflammatoire par immunoessai.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    After all data has been collected after the LVLS (Last Visit, Last Subject) and the final database has been "frozen" and locked.
    Après que toutes les données aient été collectées après la DVDS (Dernière Visite, Dernier Sujet) et que la base de données finale aie été "gelée" et verrouillée.
    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 months
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    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)
    After he/she has ended its participation in the trial, the subject will be followed according to standard care practice to its pathology.
    Après avoir mis fin à sa participation à l'étude, le sujet sera suivi selon les pratiques habituelles de soins de sa pathologie.
    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 Decision2020-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-30
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