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    Summary
    EudraCT Number:2019-003125-21
    Sponsor's Protocol Code Number:P170915J
    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:2020-01-27
    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 number2019-003125-21
    A.3Full title of the trial
    EFFECT OF INTRAVENOUS IRON SUPPLEMENTATION ON CELIAC DISEASE REMISSION IN PATIENTS WITH IRON DEFICIENCY AND INTESTINAL VILLOUS ATROPHY: A RANDOMIZED TRIAL
    Effet de la supplémentation en fer par voie intraveineuse sur la rémission de la maladie cœliaque chez les patients présentant une carence en fer et une atrophie villositaire intestinale: essai randomisé.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT OF INTRAVENOUS IRON SUPPLEMENTATION ON CELIAC DISEASE REMISSION IN PATIENTS WITH IRON DEFICIENCY AND INTESTINAL VILLOUS ATROPHY: A RANDOMIZED TRIAL
    Effet de la supplémentation en fer par voie intraveineuse sur la rémission de la maladie cœliaque chez les patients présentant une carence en fer et une atrophie villositaire intestinale: essai randomisé.
    A.3.2Name or abbreviated title of the trial where available
    IRONCEL
    A.4.1Sponsor's protocol code numberP170915J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 supportASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailkarine.goude@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 Yes
    D.2.1.1.1Trade name FERINJECT 50 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderVIFOR FRANCE
    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 INNFERRIC CARBOXYMALTOSE
    D.3.9.1CAS number 9007-72-1
    D.3.9.4EV Substance CodeSUB66620
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Celiac patients with iron deficiency and intestinal villous atrophy
    Patients atteints de la maladie cœliaque présentant une carence en fer et une atrophie villositaire de l'intestin
    E.1.1.1Medical condition in easily understood language
    Celiac patients with iron deficiency and intestinal villous atrophy
    Patients atteints de la maladie cœliaque présentant une carence en fer et une atrophie villositaire de l'intestin
    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
    The main objective is to assess the efficacy of intravenous iron supplementation on celiac disease remission (total intestinal mucosal recovery).
    L'objectif principal est d'évaluer l'efficacité de la supplémentation en fer par voie intraveineuse sur la rémission de la maladie cœliaque (cicatrisation muqueuse intestinale totale).
    E.2.2Secondary objectives of the trial
    The second objectives are to assess in patients with celiac disease, iron deficiency and villous atrophy:
    - the presence of atrophic gastritis on first and control gastric biopsies
    - the efficacy of intravenous iron supplementation on :
    o partial intestinal mucosal recovery
    o correction of iron deficiency
    o correction of anemia
    o the number of intestinal intraepithelial lymphocytes
    o expression of CD71 at the apical site of enterocytes
    o increase of body mass index
    o correction of malnutrition
    o prevention of autoimmune complications
    o abdominal pain and diarrhea
    o quality of life
    - the tolerance of intravenous iron infusion
    - the compliance to gluten free diet
    Evaluer chez les patients atteints de maladie cœliaque, avec carence en fer et atrophie villositaire:
    - la présence d’une gastrite atrophique sur les biopsies gastriques initiales et de contrôle
    - l'efficacité de la supplémentation en fer par voie intraveineuse sur:
    o la cicatrisation partielle de la muqueuse intestinale
    o la correction de la carence en fer
    o la correction de l'anémie
    o le nombre de lymphocytes intraépithéliaux intestinaux
    o l'expression du CD71 au site apical des entérocytes
    o l'augmentation de l'indice de masse corporelle
    o la correction de la malnutrition
    o la prévention des complications auto-immunes
    o les douleurs abdominales et la diarrhée
    o la qualité de vie
    - la tolérance de la perfusion de fer par voie intraveineuse
    - la compliance au régime sans gluten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients free of mental illness, able to sign consent and > 18years
    - Celiac disease confirmed by presence of serum celiac antibodies and villous atrophy on intestinal biopsy before starting gluten free diet
    - Intestinal villous atrophy on duodenal biopsy (performed within 1 month) showing villous atrophy
    - Patient under gluten free diet or starting gluten free diet with strict compliance
    - Hemoglobin level (Hb) < 12g/dL & Hb > 8g/dL
    - Well tolerated anemia
    - Iron deficiency defined by: serum iron level < 11 µmol/L, ferritinemia < 20µg/L and/or transferin saturation index ≤ 0.2
    - Patients non atteints de maladie mentale, capables de signer leur consentement et > 18 ans
    - Maladie cœliaque confirmée par la présence d'anticorps sériques cœliaques et une atrophie villositaire sur une biopsie intestinale avant le début d'un régime sans gluten
    - Atrophie des villosités intestinales sur biopsies duodénales (réalisées dans un délai d'un mois) montrant une atrophie villositaire
    - Patient sous régime sans gluten ou débutant un régime sans gluten avec le respect strict de celui-ci
    - Taux d'hémoglobine (Hb) < 12g/dL et Hb > 8g/dL
    - Anémie bien tolérée
    - Carence en fer définie par: taux de fer sérique < 11µmol/L, ferritinémie < 20µg/L et/ou indice de saturation en transferine ≤ 0,2
    E.4Principal exclusion criteria
    - Complicated celiac disease : intestinal malignancies
    - Severe anemia (Hb < 8g/dL) and/or poorly tolerated anemia requiring systematic iron IV supplementation or blood transfusion
    - Serious severe disease having short-term prognostic implication
    - Contraindication to intravenous iron infusion
    - Pregnant or breastfeeding women
    - Participation in another trial
    - Patients treated by steroids, immunosuppressors or chemotherapy drugs
    - Maladie cœliaque compliquée: complications malignes intestinales
    - Anémie sévère (Hb < 8 g/dL) et / ou anémie mal tolérée nécessitant une supplémentation systématique en fer IV ou une transfusion sanguine
    - Maladie grave ayant une implication pronostique à court terme
    - Contre-indication à la perfusion intraveineuse de fer
    - Femmes enceintes ou allaitantes
    - Participation à une étude clinique
    - Patients traités par corticoïdes, immunosuppresseurs ou chimiothérapies
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of patients with total villous recovery (total remission) on the last duodenal biopsies. Six formalin and 2 frozen duodenal biopsies will be performed. Intestinal mucosal assessment will be performed by a centralized histological analysis according to Marsh classification.
    Readers will be blind to the received treatment.
    Le critère d'évaluation principal est la proportion de patients en repousse villositaire totale (rémission complète) sur les dernières biopsies duodénales. Six biopsies duodénales formol et deux biopsies duodénales congelées seront effectuées. L'évaluation de la muqueuse intestinale sera réalisée par une analyse histologique centralisée selon la classification de Marsh. Les lecteurs seront en aveugle de bras de traitement reçu.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    - Proportion of patients with atrophic gastritis at V0 and at V14 biopsies (2 in the antrum, 1 in the angulus and 2 in the fundus)
    - Proportion of patients with partial recovery of intestinal villous atrophy on the last control duodenal biopsies according to Marsh classification (centralized histological analysis). Six formalin and two frozen duodenal biopsies will be performed.
    - Proportion of patients correcting iron deficiency. Iron parameters (serum iron level (µmol/L), ferritinemia (µg/L), transferin saturation index) will be assessed at visit V1, V3, V6, V10, V14; correction of iron deficiency is defined by serum iron level > 20 µg/L and transferin saturation index ≥ 0.20
    - Proportion of patients correcting anaemia. Hemoglobin (Hb) level (g/d) will be measured at visit V1, V3, V6, V10, V14. Correction of anaemia is defined by Hb ≥ 12g/L in woman and Hb ≥ 13g/dL in man
    - Count of intraepithelial lymphocytes assessed on initial and last control biopsy
    - Expression of CD71 on epithelial cells studied on initial and last control biopsy
    - Body Mass Index value assessed at visit V1, V3, V6, V10, and V14
    - Proportion of patients recovering normal nutritional parameters. Serum folate level (µg/L), vitamin B12 (pmol/L), calcemia (mmol/L), albuminemia (g/L), corrected calcemia (mmol/L), 25(OH)D3 vitamin mesured at visit V1, V3, V6, V10, V14
    - Serum levels of liver enzymes (AST, ALT, AP, gGT, Total Bilirubin), glycemia, T4, TSH measured at visit V1,V3, V6,V10,V14
    - Clinical symptoms: diarrhea (daily number of stools), abdominal pain assessed at each visit (n=14)
    - French Celiac disease questionnaire assessed at V1 and V14
    - Proportion of subcutaneous diffusion, allergic reactions, hemodynamic failure evaluated at each visit
    Observance of gluten free diet will be assessed by dietician assessment of gluten free consumption (g/day), measurement of serum celiac antibodies (anti-tTG IgA and anti-deamidated gliadin IgG) and detection of gluten immunogenic peptides excretion in urine at visit V1, V3, V6, V10, V14
    Les paramètres secondaires sont les suivants :
    - Proportion de patients atteints de gastrite atrophique sur les biopsies réalisées à la V0 et à la V14 (2 dans l'antre, 1 sur l'angulus et 2 dans fundus)
    - Proportion de patients avec une repousse partielle des villosités intestinales lors des dernières biopsies duodénales évaluées selon la classification de Marsh (analyse histologique centralisée). Six biopsies duodénales formol et deux biopsies duodénales congelées seront effectuées.
    - Proportion de patients corrigeant leurs carences en fer. Les paramètres du fer (taux de fer sérique (µmol/L), ferritinémie (µg/L), indice de saturation en transférine) seront évalués lors des visites V1, V3, V6, V10, V14; la correction de la carence martiale est définie par un taux de fer sérique > 20µg/L et un indice de saturation en transférine ≥ 0,20
    - Proportion de patients corrigeant l'anémie. Le taux d'hémoglobine (Hb) (g/dL) sera mesuré aux visites V1, V3, V6, V10 et V14. La correction de l'anémie est définie par Hb ≥ 12g/dL chez la femme et par Hb ≥ 13g/dL chez l'homme
    - Nombre de lymphocytes intraépithéliaux évalués lors de la biopsie duodénale initiale et de contrôle
    - Expression de CD71 sur des cellules épithéliales étudiées lors de la biopsie duodénale initiale et de contrôle
    - Valeur de l'indice de masse corporelle évaluée aux visites V1, V3, V6, V10 et V14
    - Proportion de patients retrouvant des paramètres nutritionnels normaux. Taux de folates dans le sérum (µg /L), vitamine B12 (pmol/L), calcémie (mmol/L), albuminémie (g/L), calcémie corrigée (mmol/L), vitamine 25 (OH) D3 mesurée lors de la visite V1, V3, V6, V10, V14
    - Niveaux sériques des enzymes hépatiques (ASAT, ALAT, PAL,gGT, bilirubine totale), glycémie, T4, TSH mesurés à la visite V1, V3, V6, V10, V14
    - Symptômes cliniques: diarrhée (nombre quotidien de selles), douleurs abdominales évaluées à chaque visite (n = 14)
    - Questionnaire sur la maladie cœliaque réalisé à V1 et V14
    - Proportion de diffusion sous-cutanée, réactions allergiques, insuffisance hémodynamique évaluée à chaque visite
    L'observance du régime sans gluten sera évaluée par un diététicien sur la consommation de gluten (g/jour), le dosage des anticorps sériques cœliaques (IgA anti-tTG et anti-gliadine déamidée) et la détection de l'excrétion de peptides immunogènes au gluten dans l'urine lors de la visite V1, V3, V6, V10, V14
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 mois
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    Le groupe de comparaison ne recevra aucun traitement par voie intraveineuse
    Comparison group will not receive any intravenous treatment
    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 concerned16
    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
    LVSL
    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 months50
    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: 102
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 102
    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 No
    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 state204
    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 Decision2020-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-11
    P. End of Trial
    P.End of Trial StatusOngoing
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