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    Summary
    EudraCT Number:2018-004756-38
    Sponsor's Protocol Code Number:2018-1201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-19
    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 number2018-004756-38
    A.3Full title of the trial
    Study of thromboelastography during tranexamic acid treatment in preventing bleeding in patients with haematological malignancies presenting severe thrombocytopenia (TTRAP-bleeding)
    Evolution du thromboélastogramme lors de l’administration d’acide tranexamique en prévention des saignements chez les patients thrombopéniques sévères post chimiothérapies intensives en hématologie : Etude TTRAP-bleeding
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of thromboelastography during tranexamic acid treatment in preventing bleeding in patients with haematological malignancies presenting severe thrombocytopenia (TTRAP-bleeding)
    Evolution du thromboélastogramme lors de l’administration d’acide tranexamique en prévention des saignements chez les patients thrombopéniques sévères post chimiothérapies intensives en hématologie : Etude TTRAP-bleeding
    A.3.2Name or abbreviated title of the trial where available
    TTRAP-bleeding
    TTRAP-bleeding
    A.4.1Sponsor's protocol code number2018-1201
    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 SponsorInstitut de Cancérologie Lucien Neuwirth
    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 supportInstitut de Cancérologie Lucien Neuwirth
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Cancérologie Lucien Neuwirth
    B.5.2Functional name of contact pointMathilde Gras
    B.5.3 Address:
    B.5.3.1Street Address108 bis Avenue Albert Raimond
    B.5.3.2Town/ citySaint-Priest-en-Jarez
    B.5.3.3Post code42240
    B.5.3.4CountryFrance
    B.5.4Telephone number+330477917136
    B.5.5Fax number+330477917497
    B.5.6E-mailmathilde.gras@icloire.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 EXACYL
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris
    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.3.11 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
    Malignant hemopathy
    Hémopathie maligne
    E.1.1.1Medical condition in easily understood language
    Malignant hemopathy
    Hémopathie maligne
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Describe the evolution of thromboelastogram with tranexamic acid IV (usual dose of 3g / day versus a low dose of 1.5g / day versus no treatment) used to prevent bleeding observed during intensive chemotherapy in hematology during the period of severe thrombocytopenia (<50G / L).
    Décrire l’évolution du thromboélastogramme sous acide tranexamique IV (dose habituelle de 3g/j versus dose faible de 1.5g/j versus sans traitement) utilisé en prévention des saignements observés lors de chimiothérapies intensives en hématologie durant la période de thrombopénie sévère (<50G/L).
    E.2.2Secondary objectives of the trial
    - evaluation of the anti-fibrinolytic activity by the other parameters
    - overall assessment of coagulation
    - assessment of clot fibrin
    - incidence of bleeding episodes
    - tolerance (incidence of side effects: thromboembolic event, nausea, vomiting, diarrhea, color vision disorder, skin allergy, convulsions, acute tubular necrosis, death).
    - évaluation de l’activité anti-fibrinolytique par les autres paramètres
    - évaluation globale de la coagulation
    - évaluation de la fibrine du caillot
    - incidence d’épisodes hémorragiques
    - tolérance (incidence des effets secondaires : évènement thromboembolique, nausées, vomissements, diarrhée, trouble de la vision des couleurs, allergie cutanée, convulsions, nécrose tubulaire aiguë, décès).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Major patient affiliated or entitled to a social security scheme
    - Patient with haematological malignancy requiring intensive chemotherapy.
    - Hospitalization for aplasia with thrombocytopenia expected less than 10 G / L more than 5 days
    - Consent to participate in the signed study
    - Patient majeur affilié ou ayant droit d’un régime de sécurité sociale
    - Patient atteint d’hémopathie maligne nécessitant la réalisation d’une chimiothérapie intensive.
    - Hospitalisation pour aplasie avec thrombopénie attendue inférieure à 10 G/L plus de 5 jours
    - Consentement de participation à l’étude signé
    E.4Principal exclusion criteria
    - Pregnant woman, minor, protected major
    - Patient who is refractory to platelet transfusions or who requires a specific platelet delivery protocol
    - Patient on anticoagulant or platelet antiaggregant at baseline
    - Patient with a history of arterial or venous thromboembolism
    - Patient receiving a pro-coagulant agent (eg DDAVP, recombinant Factor VIIa, Prothrombin Complexes and / or antifibrinolytic agent within 48 hours prior to inclusion or known hypercoagulability state (induction of acute promyelocytic leukemia, disseminated intravascular coagulation, thrombotic purpura thrombocytopenic, history of veno-occlusive disease ...)
    - Patient with Grade 2 or greater bleeding from WHO within 7 days of inclusion
    - Patient with creatinine clearance <30 mL / min
    - Allergy known to tranexamic acid
    - History of convulsions
    - Patient already participating in a trial involving platelet transfusions, anti-fibrinolytics, other procoagulant agents or platelet growth factors
    - Patient having expressed his opposition to participate in the study
    - Femme enceinte, mineur, majeur protégé
    - Patient présentant un état réfractaire aux transfusions de plaquettes ou nécessitant un protocole spécifique de distribution de plaquettes
    - Patient sous anticoagulant ou antiagrégant plaquettaire à l’inclusion
    - Patient aux antécédents de maladie thromboembolique artérielle ou veineuse
    - Patient recevant un agent pro-coagulant (e.g. DDAVP, Facteur VIIa recombinant, Complexes Prothrombiniques et/ou un agent antifibrinolytique dans les 48 heures précédentes l’inclusion ou état d’hypercoagulabilité connu (induction leucémie aiguë promyélocytaire, coagulation intravasculaire disséminée, purpura thrombotique thrombocytopénique, antécédent de maladie veino-occlusive…)
    - Patient ayant présenté un saignement de grade 2 ou plus de l’OMS dans les 7 jours avant l’inclusion
    - Patient avec clairance de la créatininémie<30 mL/min
    - Allergie connue à l’acide tranexamique
    - Antécédents de convulsions
    - Patient participant déjà à un essai impliquant des transfusions plaquettaires, anti fibrinolytiques, autres agents procoagulants ou des facteurs de croissance plaquettaire
    - Patient ayant exprimé son opposition de participer à l’étude
    E.5 End points
    E.5.1Primary end point(s)
    Evolution of the thromboelastogram under the effect of tranexamic acid by the maximum amplitude of the curve EXTEM.
    Evolution du thromboélastogramme sous l’effet de l’acide tranexamique par l’amplitude maximale de la courbe EXTEM.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 days
    6 jours
    E.5.2Secondary end point(s)
    - evolution of the thromboelastogram under tranexamic acid by the other parameters of the EXTEM curve (time at the beginning of the clot, clot formation time, alpha angle, percentage of lysis after 30 min),
    - evolution of the clot fibrin by the FIBTEM curve (maximum amplitude, time at the beginning of the clot, clot formation time, alpha angle, percentage of lysis after 30 min),
    - incidence of WHO grade 2 or greater bleeding episodes during the first 30 days, number of serious grade 3-4 bleeding episodes, delay to 1st episode of bleeding, number of platelet concentrate transfusions, and erythrocytes, transfusion intervals,
    - incidence of side effects (thromboembolic event, nausea, vomiting, diarrhea, color vision disorder, skin allergy, seizures, acute tubular necrosis, death)
    - évolution du thromboélastogramme sous acide tranexamique par les autres paramètres de la courbe EXTEM (temps au début du caillot, temps de formation du caillot, angle alpha, pourcentage de lyse après 30min),
    - évolution de la fibrine du caillot par la courbe FIBTEM (amplitude maximale, temps au début du caillot, temps de formation du caillot, angle alpha, pourcentage de lyse après 30min),
    - incidence d’épisodes hémorragiques de grade 2 ou plus de l’OMS durant les 30 premiers jours, nombre d’épisodes hémorragiques graves de grade 3-4, délai jusqu’au 1er épisode de saignement, nombre de transfusions en concentrés de plaquettes et érythrocytaires, intervalles transfusionnels,
    - incidence des effets secondaires (évènement thromboembolique, nausées, vomissements, diarrhée, trouble de la vision des couleurs, allergie cutanée, convulsions, nécrose tubulaire aiguë, décès)
    E.5.2.1Timepoint(s) of evaluation of this end point
    120 days
    120 jours
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Prevention
    Prévention
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Pas de traitement ou le même traitement mais à une dose plus faible
    No treatment or same treatment with lower dose
    E.8.2.4Number of treatment arms in the trial3
    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 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
    Last visit of the last subject
    Dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state18
    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)
    Plans for treatment or care after the subject has ended the participation in the trial will be the same from the expected normal treatment of that condition
    Le plan de traitement une fois la participation à l'étude terminé sera le même que la prise en charge standard.
    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 Decision2019-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-11
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