Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43858   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-005065-31
    Sponsor's Protocol Code Number:9769
    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:2017-05-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2016-005065-31
    A.3Full title of the trial
    Comparison of preoperative hemoglobin after administration of epoetin alpha associated with oral martial supplementation vs intraveinous martial supplementation before craniosynostosis in children
    Comparaison du taux d’hémoglobine préopératoire après administration d’époétine alpha associée à une supplémentation martiale orale versus intraveineuse avant chirurgie de crâniosténose chez l’enfant »
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of the administration of epoetin with intraveinous martial supplementation before craniosynostosis in children
    Evaluation d'une administration d’époétine alpha associée à une supplémentation martiale intraveineuse avant chirurgie de crâniosténose chez l’enfant
    A.4.1Sponsor's protocol code number9769
    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 SponsorUniversity hospital of Montpellier
    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 supportUniversity hospital of Montpellier
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Montpellier
    B.5.2Functional name of contact pointChauveton Claire
    B.5.3 Address:
    B.5.3.1Street AddressDRI- Pav 32 - 39 avenue Charles Flahault
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number0033467330924
    B.5.5Fax number0033467330924
    B.5.6E-mailc-chauveton@chu-montpellier.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
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire VIFOR FRANCE S.A.
    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/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 FUMAFER
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS
    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 Powder for oral solution
    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 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
    Craniosynostosis
    craniostenose
    E.1.1.1Medical condition in easily understood language
    Craniosynostosis
    craniostenose
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 compare the efficacy of two strategies of martial supplementation, oral or intravenous associated with EPO on preoperative hemoglobin in children before Craniosynostosis
    Comparer l’efficacité de deux stratégies d'apport martial, oral ou intraveineux, associées à l'EPO, sur le taux d’hémoglobine préopératoire chez l’enfant avant craniostenose
    E.2.2Secondary objectives of the trial
    To compare the changes in Hemoglobin after EPO administration as a function of the reference martial balance (at inclusion), in both groups.
    - To Compare between the 2 groups:
    • the rates of patients who did not receive the 3rd injection of EPO because their hemoglobin rate was greater than or equal to 15 g / dl after the 2nd injection.
    • the evolution of the martial stock between the 2 groups
    • the occurrence of treatment-related adverse events
    • the compliance of martial treatment
    • blood savings calculated by the assessment of perioperative blood loss,
    • the number of patients transfused and the quantity in ml / kg of transfused blood
    • treatment costs
    - Etudier les variations du taux d’Hb secondaire à l’administration d’EPO, en fonction du bilan martial de référence (au moment de l’inclusion), en tenant compte du taux de la CRP de référence, dans les deux groupes.
    - Comparer entre les 2 groupes:
    • les taux de patients n’ayant pas reçu la 3eme injection d’EPO car leur concentration d’hémoglobine était supérieure ou égale à 15g/dl après la 2ème injection.
    • l’évolution du stock martial entre les 2 groupes
    • la survenue d’événements indésirables liés aux traitements
    • évaluation de l’observance du traitement martial
    • l’épargne sanguine calculée par l’évaluation des pertes sanguines periopératoires,
    • le nombre de patients transfusés et la quantité en ml/kg de sang transfusé
    • les coûts des traitements
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Craniosynostosis Surgery
    - Age: between 4 and 24 months
    - Weight: less than 12kg
    - Hemoglobin: 10 g / dl ≤ Hb 14 ≤ g / dl
    - Affiliated patients or beneficiaries of a health protection
    - Signature of the consent of the patient's parents
    - Chirurgie de crâniosténose
    - Age : entre 4 et 24 mois inclus
    - Poids : moins de 15kg 12kg
    - Taux d'hémoglobine : 10 g/dl ≤ Hb 14 ≤g/dl
    - Patients affiliés ou bénéficiaires d'un régime de Sécurité Sociale
    - Signature du consentement des parents du patient
    E.4Principal exclusion criteria
    -Generalized infection
    -Time for consultation of anesthesia with respect to the date of surgery greater than 5 weeks or less than 22 days.
    - Initial biological assessment dating more than 3 months before the consultation of anesthesia
    - parents do not understand French
    - BMI greater than 20 kg.m-2
    • Contraindications to EPO:
    - Erythroblastopenia following treatment with epoetin alpha
    -Malignant and uncontrolled HTA
    - Hypersensitivity to Eprex®
    - Severe cardio-vascular disease
    - Severe thromboembolic risk
    -Evolutionary neoplastic pathology
    - Contraindications to Ferinject® and Fumafer®:
    - Known hypersensitivity to Ferinject® or Fumafer® or to any of its excipients
    - Known severe hypersensitivity to any other parenteral iron
    Fertilization> 200 μg / l or CST> 45% o All situations of martial overload (especially normo or hypersidemic anemia such as thalassemia, refractory anemia, anemia due to medullary insufficiency) or iron use disorders (hemochromatosis, haemosiderosis) .
    Known hepatic dysfunction
    - Chronic renal insufficiency
    - Late cutaneous porphyria
    - Infection généralisée
    - Délai de la consultation d’anesthésie par rapport à la date de la chirurgie supérieur à 5 semaines ou inférieur à 22 jours.
    - Bilan biologique initial datant de plus de 3 mois avant la consultation d’anesthésie
    - Parents non francophonesne comprenant pas le français
    - IMC supérieur à 20 kg.m-2
    •Contre-indications à l'EPO :
    - Erythroblastopénie à la suite d'un traitement par une époétine alpha
    - HTA maligne et non contrôlée
    - Hypersensibilité à l'Eprex®
    - Pathologie cardio vasculaire sévère
    - Risque thromboembolique sévère
    - Pathologie néoplasique évolutive
    • Contre-indications au Ferinject® et au Fumafer®:
    -Hypersensibilité connue au Ferinject® ou au Fumafer® ou à l’un de ses excipients
    -Hypersensibilité grave connue à tout autre fer administré par voie parentérale
    -Toutes les situations de surcharge martiale (en particulier anémie normo ou hypersidérémique telles que thalassémie, anémie réfractaire, anémie par insuffisance médullaire) ou troubles d'utilisation du fer (hémochromatose, hémosidérose) : ferritinémie > 200 µg/l ou CST > 45%.
    oDysfonction hépatique connue
    oInsuffisance rénale chronique
    oPorphyrie cutanée tardive
    E.5 End points
    E.5.1Primary end point(s)
    Variation of the Hb level between the reference value taken immediately before the introduction of the treatment and the preoperative Hemoglobin taken the day before surgery
    Variation du taux d'Hb entre la valeur de référence prélevée immédiatement avant l’introduction du traitement, et le taux d'Hb préopératoire prélevée à J-1, la veille de l'intervention
    E.5.1.1Timepoint(s) of evaluation of this end point
    the day before surgery
    la veille de l'intervention de craniostenose
    E.5.2Secondary end point(s)
    1.Change in Hemoglobin rate between the reference value taken immediately before the introduction of the treatment and the preoperative Hb taken the day before the intervention, according to the reference martial balance.

    2.Change in Hb between the reference value taken immediately before the introduction of the treatment and the preoperative Hb taken at D-1, the day before the intervention, according to the patient's inflammatory state Evaluated by the PRC level before treatment.

    3.Frequency of stopping EPO treatment at the end of the 2nd injection

    4. Evolution of the martial stock: before treatment and the day before the intervention

    5. Occurrence of adverse events

    6. Compliance of martial treatment per os evaluated by an observational scale and an analogic visual scale.

    7. Use of intraoperative blood transfusion (and SSPI) and within 3 postoperative days.

    8. Number of intraoperative transfused red blood cells (and SSPI) and within 3 postoperative days.

    9. Volume of transfused globulin concentrate in ml / kg

    10. Blood loss at day 3

    11. Cost of treatment with Fumafer compared to treatment with Ferinject
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. The day before the surgery
    2. The day before the surgery
    3. until the surgery
    4.The day before the surgery
    5.until 3 days after the surgery
    6.The day before the surgery
    7.until 3 days after the surgery
    8.Until 3 days after the surgery
    9.Until 3 days after the surgery
    10.Until 3 days after the surgery
    11. At the end of the study
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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) Yes
    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 concerned2
    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 Yes
    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
    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 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 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) Yes
    F.1.1.4.1Number of subjects for this age range: 50
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception 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 state50
    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
    Prise en charge habituelle.
    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 Decision2017-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-09
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 11:12:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA