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    Summary
    EudraCT Number:2020-000311-71
    Sponsor's Protocol Code Number:APHP180572
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-000311-71
    A.3Full title of the trial
    Pilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of UC with pediatric onset
    Etude pilote d’une nouvelle technique de Transplantation Fécale Orale utilisant des gélules de selles congelées pour le traitement d’entretien des RCH à début pédiatrique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of UC with pediatric onset
    Etude pilote d’une nouvelle technique de Transplantation Fécale Orale utilisant des gélules de selles congelées pour le traitement d’entretien des RCH à début pédiatrique
    A.3.2Name or abbreviated title of the trial where available
    Transplantation Fécale Orale pour la RCH de l’Enfant
    A.4.1Sponsor's protocol code numberAPHP180572
    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 SponsorAP-HP/DRCD
    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 supportAP-HP/DRCI
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAP-HP /DRCI
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+33144 84 17 98
    B.5.5Fax number+33144 84 17 01
    B.5.6E-mailaurelie.guimfack@aphp.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 No
    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 nameMicrobiote fécal
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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
    ulcerative colitis
    rectocolite hémorragique
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory bowel disease (IBD)
    Maladies inflammatoires chroniques de l'intestin (MICI)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    To assess whether TMF by frozen stool capsules in pediatric patients with UC, in remission after treatment with corticosteroids, makes it possible to modify their dysbiotic microbiota by increasing the richness of their microbiota at 6 months.
    Evaluer si la TMF par gélules de selles congelées chez les patients pédiatriques atteints de RCH, en rémission après traitement par corticoïdes, permet de modifier leur microbiote dysbiotique en augmentant la richesse de leur microbiote à 6 mois.
    E.2.2Secondary objectives of the trial
    Avaluate
    1.TMF by capsules increases the richness of their microbiota at 12 months
    2. TMF by enemas increases the richness of their microbiota at 6 months and 12 months.
    3. TMF by capsules makes it possible to modify their dysbiotic microbiota by making it closer to that of healthy donors in the long term (at 6 and 12 months).
    4. TMF by enemas can modify their dysbiotic microbiota by making it closer to that of healthy donors in the long term (at 6 and 12 months).
    5.TMF by capsules or enemas changes their microbiota bound to the mucosa at 12 months.
    To assess
    6. the feasibility of TMF by capsules and by long-term enema.
    7. the efficacy of TMF by capsules and by enema on clinical relapse at 6 and 12 months.
    8. the effectiveness of TMF by capsules and by enema on endoscopic relapse at 12 months.
    9. the effect of capsule and enema TMF on markers of inflammation, and fecal biomarkers such as fecal calprotectin.
    10. and 11. (see protocol)
    Evaluer si la TMF:1.par gélules permet d’augmenter la richesse de leur microbiote à 12 mois.2. par lavements permet d’augmenter la richesse de leur microbiote à 6 mois et 12 mois. 3.par gélules permet de modifier leur microbiote dysbiotique en le rendant plus proche de celui des donneurs sains sur le long terme (à 6 et 12 mois).
    4.par lavements permet de modifier leur microbiote dysbiotique en le rendant plus proche de celui des donneurs sains sur le long terme (à 6 et 12 mois).
    5.par gélules ou lavements permet de modifier leur microbiote lié à la muqueuse à 12 mois.
    Evaluer
    6.la faisabilité de la TMF par gélules et par lavement au long cours. 7.l’efficacité de la TMF par gélules et par lavement sur la rechute clinique à 6 et 12 mois.8. l’efficacité de la TMF par gélules et par lavement sur la rechute endoscopique à 12 mois.9.l’effet de la TMF par gélules et par lavement sur les marqueurs de l’inflammation, et les biomarqueurs fécaux.
    10. et 11 (voir protocole)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Objective: to collect stool, urine and blood samples for each patient for analysis of AB and certain biomarkers such as defensins. We will study the variations of these markers during TMF and the modifications induced by the contribution of a non-dysbiotic microbiota. We hope to describe the links between inflammation, the composition of AB and IBD, but also to highlight new biomarkers useful for the monitoring or diagnosis of IBD.
    Objectif: recueillir pour chaque patient des échantillons de selles, d’urine et de sang pour l’analyse des AB et de certains biomarqueurs comme les défensines. Nous étudierons les variations de ces marqueurs lors de la TMF et les modifications induites par l’apport d’un microbiote non dysbiotique. Nous espérons ainsi décrire les liens existant entre l’inflammation, la composition des AB et les MICI, mais aussi mettre en évidence de nouveaux biomarqueurs utiles pour le suivi ou le diagnostic des MICI.
    E.3Principal inclusion criteria
    Criteria for inclusion of the patient "recipient" of the TMF:
    - Patient aged 8 to 17;
    - With UC, regardless of the extent, except isolated proctitis (<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria;
    - Flare-up UC defined by a PUCAI score> 35 and responding to treatment with corticosteroids at 40 mg / day maximum with, on inclusion, a PUCAI score <10;
    - Treatment of UC (5-ASA, immunosuppressants, biotherapies) stable for more than 3 months;
    - Patient capable of ingesting the test capsules;
    - For girls of childbearing age:
    - have a negative blood (or urine) pregnancy test;
    - agree to use a reliable contraceptive method from visit 1 until the end of the research;
    - Being a beneficiary of a social protection scheme or having rights (excluding AME);
    - Have an informed consent form signed by both parents or by the person (s) with parental authority.

    Inclusion criteria of the healthy voluntary subject "donor" of stool:
    - Age between 18 and 50 years old (so that the donor's microbiota is in a period of stability of its flora);
    - 17 kg / m² <BMI <30 kg / m² (<30 kg / m² according to ANSM recommendations) (the microbiota being modified according to body mass);
    - Have a usually regular transit consisting of at least one stool every two days and a maximum of 2 stools per day;
    - For women of childbearing age: have a negative pregnancy blood test;
    - Being a beneficiary of a social protection scheme or having rights (excluding AME);
    - Have a signed free and informed consent form.
    Critères d’inclusion du patient « Receveur » de la TMF :
    - Patient âgé de 8 à 17 ans ;
    - Atteint de RCH, quelle que soit l’étendue, sauf les rectites isolées (<5 cm), diagnostiquée depuis plus de 3 mois selon les critères cliniques, biologiques et endoscopiques habituels ;
    - RCH en poussée définie par un score de PUCAI > 35 et répondant au traitement par corticoïdes à 40 mg/j maximum avec à l’inclusion un score PUCAI < 10 ;
    - Traitements de la RCH (5-ASA, immunosuppresseurs, biothérapies) stables depuis plus de 3 mois ;
    - Patient capable d’ingérer les gélules test ;
    - Pour les filles en âge de procréer :
    - avoir un test sanguin (ou urinaire) de grossesse négatif ;
    - accepter d'utiliser une méthode contraceptive fiable à partir de la visite 1, et ce, jusqu'à la fin de la recherche ;
    - Etre bénéficiaire d’un régime de protection sociale ou ayant droit (hors AME) ;
    - Avoir un formulaire de consentement éclairé signé par les 2 parents ou par la (ou les) personne(s) détenant l’autorité parentale.

    Critères d’inclusion du sujet volontaire sain « Donneur » de selles :
    - Age compris entre 18 et 50 ans (afin que le microbiote du donneur soit dans une période de stabilité de sa flore) ;
    - 17 kg/m² < IMC < 30 kg/m² (< 30 kg/m² selon les recommandations ANSM) (le microbiote étant modifié en fonction de la masse corporelle) ;
    - Avoir un transit habituellement régulier composé au moins d’une selle tous les deux jours et au maximum 2 selles par jour ;
    - Pour les femmes en âge de procréer : avoir un test sanguin de grossesse négatif ;
    - Etre bénéficiaire d’un régime de protection sociale ou ayant droit (hors AME) ;
    - Avoir un formulaire de consentement libre et éclairé signé.
    E.4Principal exclusion criteria
    Criteria for non-inclusion of the TMF Receiver:
    - Have isolated proctitis (<5 cm)
    - Have severe colitis defined by a PUCAI score> 65
    - Be under enteral nutrition
    - Have received an antibiotic or antifungal treatment in the 4 weeks preceding inclusion
    - Have a Clostridioides difficile infection in the 4 weeks prior to inclusion
    - be pregnant or breastfeeding, or have a positive pregnancy test
    - Have a contraindication to colonoscopy or general anesthesia
    - Participation in another intervention research involving the human person.

    Criteria for non-inclusion of the healthy voluntary subject "donor" of stool (final and temporary) + Exclusion criteria:
    According to ANSM criteria
    See below.
    Critères de non inclusion du Receveur de la TMF :
    - Avoir une rectite isolée (<5 cm)
    - Avoir une colite sévère définie par un score PUCAI > 65
    - Etre sous nutrition entérale
    - Avoir reçu un traitement antibiotique ou antifongique dans les 4 semaines précédant l’inclusion
    - Avoir une infection à Clostridioides difficile dans les 4 semaines précédant l’inclusion
    - Etre enceinte ou allaitante, ou présenter un test de grossesse positif
    - Avoir une contre-indication à la coloscopie ou l’anesthésie générale
    - Participation à une autre recherche interventionnelle impliquant la personne humaine.

    Critères de non inclusion du sujet volontaire sain « Donneur » de selles (définitifs et temporaires) + Critères d’exclusion :
    Selon les critères de l’ANSM
    Cf. infra.
    E.5 End points
    E.5.1Primary end point(s)
    Success of TMF by frozen stool capsules, defined by an increase in the richness of the recipient's microbiota at 6 months. This will be evaluated by measuring the alpha diversity of the microbiota using the Shannon index.
    The success of TMF will be defined by an increase in the Shannon Index of 0.5 points between the recipient's microbiota at M0 and the recipient's microbiota at M6.
    Succès de la TMF par gélules de selles congelées, défini par une augmentation de la richesse du microbiote du receveur à 6 mois. Celle-ci sera évaluée par la mesure de l’alpha diversité du microbiote en utilisant l’indice de Shannon.
    Le succès de la TMF sera défini par une augmentation de l’indice de Shannon de 0,5 points entre le microbiote du receveur à M0 et le microbiote du receveur à M6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.5.2Secondary end point(s)
    1. The success of TMF by frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 12 months.
    This will be evaluated by measuring the alpha diversity of the microbiota using the Shannon index. The success of TMF will be defined by an increase in the Shannon Index of 0.5 points between the recipient's microbiota at M0 and the recipient's microbiota at M12.
    2. The success of TMF by enemas defined by an increase in the richness of the recipient's microbiota at 6 and 12 months.
    This will be evaluated by measuring the alpha diversity of the microbiota using the Shannon index. The success of TMF will be defined by an increase in Shannon's index of 0.5 points between the recipient's microbiota at M0 and the recipient's microbiota at M6 and M12.
    3. The success of TMF by capsules at 6 and 12 months defined by a microbiota of the recipient closer to that of the healthy donor than that of the recipient before the TMF, evaluated by the Bray-Curtis index (BC).
    Success will therefore be defined by an index of BC [recipient after TMF vs. donor] higher than the BC index [recipient after TMF vs. recipient before TMF]), with an index of BC [recipient after TMF vs. donor] ≥ 0.6.
    4. The success of TMF by enemas at 6 and 12 months defined by a microbiota of the recipient after TMF closer to that of the healthy donor than to that of the recipient before TMF.
    Success will be defined by an index of BC [recipient after TMF vs. donor]> BC index [recipient after TMF vs. recipient before TMF] with an index of BC [recipient after TMF vs. donor] ≥ 0.6.
    5. The modification of the microbiota associated with the mucosa at 0 and 12 months. The microbiota associated with the mucosa will be studied on the biopsies collected during colonoscopies at M0 and M12, and the microbiota will be analyzed by the MISeq technique (16S RNA). The same success criteria will be analyzed as for the faecal microbiota at M0 and M12 (using the Shannon index and the Bray-Curtis index).
    6. The feasibility of TMF by capsules and by long-term enemas in children with UC will be evaluated by the number of capsules ingested, the ease of taking the capsules, the quantity of enemas actually received, the acceptability of the capsule. TMF, the duration of administration, and the difficulties encountered during the installation of the enema (s).
    7. Clinical relapse of UC at 6 and 12 months is defined by a PUCAI score> 35 (see appendix), the treatments received during follow-up and the number of relapses during follow-up.
    8. Endoscopic relapse at 12 months will be measured by the endoscopic activity score (UCEIS, see appendix) at colonoscopy at 12 months. The relapse will be defined by a UCEIS score ≥ 2.
    9. The effect of TMF on markers of inflammation will be measured by blood assays for CRP and VS, leukocytes and fecal calprotectin at M0, M6, M9 and M12.
    The determination of fecal calprotectin will be carried out at the Functional Coprology Laboratory of Prof. Nathalie Kapel of the Pitié Salpêtrière hospital.
    10. The evolution of the quality of life in the 2 treatment arms evaluated by the IMPACT-3 questionnaire (35 closed questions, Likert scale from 1 to 5 [overall score: 35-175]). A high score suggests a better quality of life.
    11. Collection of adverse events: fever, sepsis, infection, flare-up of inflammatory disease, etc. will be noted throughout the follow-up.
    1. Le succès de la TMF par gélules de selles congelées défini par une augmentation de la richesse du microbiote du receveur à 12 mois.
    Celle-ci sera évaluée par la mesure de l’alpha diversité du microbiote en utilisant l’indice de Shannon. Le succès de la TMF sera défini par une augmentation de l’indice de Shannon de 0,5 points entre le microbiote du receveur à M0 et le microbiote du receveur à M12.
    2. Le succès de la TMF par lavements défini par une augmentation de la richesse du microbiote du receveur à 6 et 12 mois.
    Celle-ci sera évaluée par la mesure de l’alpha diversité du microbiote en utilisant l’indice de Shannon. Le succès de la TMF sera défini par une augmentation de l’indice de Shannon de 0,5 points entre le microbiote du receveur à M0 et le microbiote du receveur à M6 et M12.
    3. Le succès de la TMF par gélules à 6 et 12 mois défini par un microbiote du receveur plus proche de celui du donneur sain que de celui du receveur avant la TMF, évalué par l’index de Bray-Curtis (BC).
    Le succès sera donc défini par un indice de BC [receveur après TMF vs. donneur] supérieur à l’indice de BC [receveur après TMF vs. receveur avant TMF]), avec un indice de BC [receveur après TMF vs. donneur] ≥ 0,6.
    4. Le succès de la TMF par lavements à 6 et 12 mois défini par un microbiote du receveur après la TMF plus proche de celui du donneur sain que de celui du receveur avant la TMF.
    Le succès sera défini par un indice de BC [receveur après TMF vs. donneur] > indice de BC [receveur après TMF vs. receveur avant TMF] avec une indice de BC [receveur après TMF vs. donneur] ≥ 0,6.
    5. La modification du microbiote associé à la muqueuse à 0 et 12 mois. Le microbiote associé à la muqueuse sera étudié sur les biopsies recueillies lors des coloscopies à M0 et M12, et, l’analyse du microbiote sera faite par la technique MISeq (ARN 16S). On analysera les mêmes critères de succès que pour le microbiote fécal à M0 et M12 (en utilisant l’indice de Shannon et l’indice de Bray-Curtis).
    6. La faisabilité de la TMF par gélules et par lavements au long cours chez les enfants atteints de RCH sera évaluée par le nombre de gélules ingérées, la facilité de la prise des gélules, la quantité de lavements effectivement reçue, l’acceptabilité de la TMF, la durée d’administration, et les difficultés rencontrées lors de la pose du ou des lavement(s).
    7. La rechute clinique de la RCH à 6 et 12 mois est définie par un score de PUCAI > 35 (cf. annexe), les traitements reçus pendant le suivi et le nombre de rechute(s) au cours du suivi.
    8. La rechute endoscopique à 12 mois sera mesurée par le score d’activité endoscopique (UCEIS, cf. annexe) à la coloscopie à 12 mois. La rechute sera définie par un score UCEIS ≥ 2.
    9. L’effet de la TMF sur les marqueurs de l’inflammation sera mesuré par les dosages sanguins de CRP et de VS, des leucocytes et la calprotectine fécale à M0, M6, M9 et M12.
    Le dosage de la calprotectine fécale sera effectué au Laboratoire de Coprologie Fonctionnelle du Pr Nathalie
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 months
    6 et 12 mois
    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 No
    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 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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 concerned4
    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
    LVLS
    DVDP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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 Yes
    F.1.1Number of subjects for this age range: 50
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 35
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 No
    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 state80
    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 Decision2022-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-04
    P. End of Trial
    P.End of Trial StatusOngoing
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