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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

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    Summary
    EudraCT Number:2015-002175-24
    Sponsor's Protocol Code Number:2014_68
    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:2015-08-05
    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 number2015-002175-24
    A.3Full title of the trial
    Effect of the exacyl on perioperative bleeding during surgery of orthognatism of the upper maxillary
    Effet de l’EXACYL sur le saignement péri opératoire lors de chirurgie d’orthognatisme du maxillaire supérieur
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of the EXACYL on the bleeding during an operation of the bones of the upper jaw
    Effet de l'EXACYL sur le saignement durant une opération des os de la machoire supérieure
    A.3.2Name or abbreviated title of the trial where available
    LEFORT1/EXACYL
    LEFORT1/EXACYL
    A.4.1Sponsor's protocol code number2014_68
    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 et Universitaire de Lille
    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 supportCHRU de Lille
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Régional et Universitaire de Lille
    B.5.2Functional name of contact pointHanane TIJANI
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Oscar Lambret
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number00330320444145
    B.5.5Fax number00330320445711
    B.5.6E-mailDRC@chru-lille.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.2.1.1.1Trade name EXACYL 0,5 g/5 mL I.V., solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-ANVENTIS 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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bleeding during surgery of orthognatism of the upper maxillary
    Saignement lors de chirurgie d'orthognatisme du maxillaire supérieur
    E.1.1.1Medical condition in easily understood language
    Bleeding during an operation of the bones of the upper jaw
    Saignement durant une opération des os de la mâchoire supérieure
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    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
    Show that the EXACYL, in preventive, does not allow to modify the bleeding by comparison to the placebo during surgery of orthognatisme of the upper maxillary.
    Montrer que l’EXACYL, en préventif, ne permet pas de modifier le saignement par comparaison au placebo lors de chirurgie d’orthognatisme du maxillaire supérieur.
    E.2.2Secondary objectives of the trial
    Compare according to the 2 groups:
    - The quantity of blood during the surgery
    - The surgical comfort
    - The operating duration
    - The variation of hemoglobin
    - The comfort of the patient
    - The number of transfused caps
    - Fatigue of the patient
    - The duration of hospitalization
    Describe the adverse effects and possible complications of the drip of EXACYL
    Comparer selon les 2 groupes :
    - la quantité de sang pendant la chirurgie
    - le confort chirurgical
    - la durée opératoire
    - la variation d’hémoglobine
    - le confort du patient
    - le nombre de culots transfusés
    - la fatigue du patient
    - la durée d’hospitalisation
    Décrire les effets indésirables et les complications possibles de la perfusion d’EXACYL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Underage from ≥ 12 to 17 years old or an Adult from ≥ 18 years old
    - Patient that must be operated for an osteotomy of the upper maxillary isolated or associated with an osteotomy of the lower maxillary and / or with a génioplastie within the framework of a surgery of orthognatism
    - Hb = 12g / dL on the preoperative screening
    - Patient ASA (American Society of Anesthesiologists) 1 or 2
    - Patient non pregnant
    - Be a person covered by Social Security
    - Signed Consent
    - Mineur de ≥12 à 17 ans ou Majeur ≥ 18 ans
    - Patient devant se faire opérer d’une ostéotomie du maxillaire supérieur isolée ou associée à une ostéotomie du maxillaire inférieur et /ou à une génioplastie dans le cadre d’une chirurgie d’orthognatisme.
    - Hb ≥ 12g/dL sur le bilan préopératoire
    - Patient ASA (American Society of Anesthesiologists) 1 ou 2
    - Etre assuré social
    - Consentement signé
    E.4Principal exclusion criteria
    Patient presenting disorders of the hemostasis
    Patient under anticoagulation treatment or antiagrégant
    Patient requiring a treatment anticoagulation in operating comment
    Patient presenting a contraindication to the EXACYL (renal insufficiency engraves(burns), histories of convulsions, histories of accidents thrombo-embolics venous or arterial)
    Surgery recognized preoperative as particularly complicated by the surgeons
    Pregnant Women
    Nursing mothers
    People in emergency situation
    Incapable people and specially protected mentioned in the article L 1121-5 to L1121-8 are not included in the study
    - Patient présentant des troubles de l’hémostase
    - Patient sous traitement anticoagulant ou antiagrégant
    - Patient nécessitant un traitement anticoagulant en post opératoire
    - Patient présentant une contre-indication à l’EXACYL (insuffisance rénale grave, antécédents de convulsions, antécédents d’accidents thrombo-emboliques veineux ou artériels)
    - Chirurgie reconnue en préopératoire comme particulièrement compliquée par les chirurgiens
    - Femmes enceintes
    - Femmes allaitantes
    - Personnes en situation d’urgence
    - Personnes incapables et spécialement protégées mentionnées à l'art L 1121-5 à L1121-8 ne sont pas incluses dans l'étude
    E.5 End points
    E.5.1Primary end point(s)
    Show that the EXACYL does not allow to modify the bleeding by comparison to the placebo during surgery of orthognatisme of the upper maxillary.
    Montrer que l’EXACYL ne permet pas de modifier le saignement par comparaison au placebo lors de chirurgie d’orthognatisme du maxillaire supérieur.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Quantity of blood during the whole hospitalization: bleeding during the surgery completed by the quantity of present blood in redons and the naso-gastric probe until ablation of these.
    Quantité de sang pendant l’ensemble de l’hospitalisation : saignement pendant la chirurgie complété de la quantité de sang présent dans les redons et la sonde naso-gastrique jusqu’à ablation de ceux-ci. information in other language that is applicable
    E.5.2Secondary end point(s)
    Compare according to the 3 groups:
    - The quantity of blood during the surgery
    - The surgical comfort
    - The operating duration
    - The variation of hemoglobin
    - The comfort of the patient
    - The number of transfused caps
    - Fatigue of the patient
    - The duration of hospitalization
    Describe the adverse effects and the possible complications of the drip of EXACYL
    Comparer selon les 3 groupes :
    - la quantité de sang pendant la chirurgie
    - le confort chirurgical
    - la durée opératoire
    - la variation d’hémoglobine
    - le confort du patient
    - le nombre de culots transfusés
    - la fatigue du patient
    - la durée d’hospitalisation
    Décrire les effets indésirables et les complications possibles de la perfusion d’EXACYL
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Quantity of blood during the including surgery: the blood in the surgical suction, in the compresses (estimate by weighing of compresses), in the anesthetic suction (during the extubation) and in the naso-gastric probe at the end of the surgery
    - Operating duration
    - Difference between the rate of preoperative hemoglobin and the operating comment
    - Analog visual scale for the evaluation of the comfort of the patient to D1
    - Number of transfused cap
    - Analog visual scale for the evaluation of the fatigue of the patient at the release of hospitalization
    - Incidence of the nausea and the vomitings and total dose of antiemetic
    - Number of thrombotic complications/cardiac complications during the period of the hospitalization
    - Quantité de sang pendant la chirurgie comprenant : le sang dans l’aspiration chirurgicale, dans les compresses (évaluer par pesage des compresses), dans l’aspiration anesthésique (lors de l’extubation) et dans la sonde naso-gastrique à la fin de la chirurgie
    - Durée opératoire
    - Différence entre le taux d’hémoglobine préopératoire et post opératoire
    - Echelle visuelle analogique pour l’évaluation du confort du patient à J1
    - Nombre de culot transfusé
    - Echelle visuelle analogique pour l’évaluation de la fatigue du patient à la sortie d’hospitalisation
    - Incidence des nausées et vomissements et dose totale d’antiémétique
    - Nombre de complications thrombotiques/ de complications cardiaques pendant la période de l’hospitalisation
    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 Yes
    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
    Study of concept
    Etude de concept
    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 No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Triple insu
    Triple Blind
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Dernière Visite du Dernier Patient
    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 months6
    E.8.9.1In the Member State concerned days5
    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: 189
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 189
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 21
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-08-05. Yes
    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 state210
    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 Decision2015-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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