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   43861   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:2013-002484-26
    Sponsor's Protocol Code Number:FIDEL
    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:2015-09-24
    Trial results View 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 number2013-002484-26
    A.3Full title of the trial
    A RANDOMISED, MULTICENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ON THE EFFICACY AND SAFETY OF A THERAPEUTIC STRATEGY OF POST PARTUM HAEMORRHAGE COMPARING EARLY ADMINISTRATION OF HUMAN FIBRINOGEN VERSUS PLACEBO IN PATIENTS TREATED WITH INTRAVENOUS PROSTAGLANDINS FOLLOWING VAGINAL DELIVERY.
    Etude multicentrique randomisée en double aveugle évaluant les bénéfices et la tolérance d’une stratégie thérapeutique de prise en charge de l’hémorragie du post partum associant une administration précoce de fibrinogène humain versus placebo chez des patientes traitées par prostaglandines IV après accouchement par voie basse.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the efficacy and safety of a therapeutic strategy of post partum haemorrhage comparing early administration of human fibrinogen versus placebo in patients treated with intravenous prostaglandins following vaginal delivery.
    Etude évaluant les bénéfices et la tolérance de la prise en charge de l'hémorragie post-accouchement par l'administration précoce de fibrinogène humain versus placebo chez des patientes traitées par des prostaglandines par voie intraveineuse après un accouchement par voie basse.
    A.4.1Sponsor's protocol code numberFIDEL
    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 SponsorLFB Biomédicaments
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLFB Biomédicaments
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLFB Biomédicaments
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address3 avenue des Tropiques
    B.5.3.2Town/ cityLes Ulis
    B.5.3.3Post code91940
    B.5.3.4CountryFrance
    B.5.6E-maildinoueln@lfb.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 CLOTTAFACT 1.5g/100ml
    D.2.1.1.2Name of the Marketing Authorisation holderLFB Biomédicaments
    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.3.1Product nameClottafact
    D.3.2Product code FGTW
    D.3.4Pharmaceutical form Powder and solvent for 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 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 Yes
    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 placeboPowder and solvent for solution for infusion
    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
    post partum haemorrhage following vaginal delivery
    Hémorragie du post-partum après accouchement par voie basse
    E.1.1.1Medical condition in easily understood language
    Haemorrhage following vaginal delivery
    Hémorragie après un accouchement par voie basse
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10036294
    E.1.2Term Postpartum haemorrhage (primary)
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectve of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion.
    L'objetif principal de l'étude est d'évaluer le bénéfice d’une stratégie thérapeutique associant une administration précoce de fibrinogène humain dans la prise en charge de l’hémorragie du post-partum sur la réduction du saignement après initiation des prostaglandines
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    •To assess the evolution of haemorrhage
    •To assess the need for haemostatic intervention
    •To assess the maternal morbi-mortality
    •To assess the biological effects of fibrinogen concentrate administration
    •To assess the tolerance of fibrinogen concentrate administration
    Les objectifs secondaires sont d'évaluer:
    •l'évolution de l'hémorragie
    •la nécessité d'un recours à une ientervention hémostatique
    •la morbi-mortalité maternelle
    •les effets biologiques en focntion des taux de fibrinogène administré
    •la tolérance en focntion des taux de fibrinogène administré
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Signed and dated informed consent form
    •Vaginal delivery
    •PPH requiring IV administration of prostaglandins
    •At least one available result of Hb level during the third trimester of pregnancy
    •18-year old female patients and older
    •Covered by healthcare insurance in accordance with local requirements
    •Consentement éclairé daté et signé
    •Accouchement par voie basse
    •Hémorragie du post-partum nécessitant une administration intraveineuse de prostaglandines
    •Au moins un résultat d’hémoglobine disponible durant le dernier trimestre de grossesse
    •Femme âgée de 18 ans ou plus
    •Patiente bénéficiaire ou ayant-droit des prestations de la sécurité sociale
    E.4Principal exclusion criteria
    •Caesarean section
    •Haemostatic intervention (as ligation, embolization or hysterectomy) already decided at the time of inclusion
    •Known placenta praevia or accreta
    •Hb level < 10g/dl during the third trimester of pregnancy
    •History of venous or arterial thromboembolic event
    •Known inherited bleeding or thrombotic disorders
    •Treatment with low-molecular-weight heparin (LMWH) within 24 hours prior to the inclusion
    •Treatment with acetylsalicylic acid within 5 days prior to the inclusion
    •Treatment with vitamin K antagonists within 7 days prior to the inclusion
    •Administration of fibrinogen concentrate within 48 hours prior to the inclusion
    •Administration of FFP, platelets units or prohaemostatic drugs,
    tranexamic acid and rFVIIa or prothrombin complex concentrates
    (PCC) within 48 hours prior to the inclusion
    •Administration of RBCs within 3 months prior to the inclusion
    •Participation in another interventional clinical study within 30 days prior to the inclusion
    •Previous inclusion/enrolment in the present clinical study
    •Known history of hypersensitivity or other severe reaction to any component of Clottafact® or placebo
    •Minors, majors under guardianship, persons staying in health or social institutes and people deprived of their freedom
    •Known drug or alcohol abuse
    •Patients whose use of concomitant medication may interfere with the interpretation of data
    •Any other current significant medical condition that might interfere with treatment evaluation according to the investigator’s judgement
    •Patients who are unlikely to survive through the treatment period and evaluation
    •Patients transferred from another service
    •Accouchement par césarienne
    •Intervention d’hémostase (comme une ligature, embolisation ou hystérectomie) déjà décidée au moment de l’inclusion
    •Placenta praevia ou accreta connu
    •Taux d'HB < 10 g/dl durant le dernier trimestre de grossesse
    •Antécédent connu d’événement thromboembolique veineux ou artériel
    •Anomalie congénitale de l’hémostase connue
    •Traitement par héparine de bas poids moléculaire (HBPM) dans les 24 heures précédant l’inclusion
    •Traitement par acide acétylsalicylique dans les 5 jours précédant l’inclusion
    •Traitement par Anti-vitamines K dans les 7 jours précédant l’inclusion
    •Administration de fibrinogène dans les 48h précédent l’inclusion
    •Administration de PFC, plaquettes ou médicaments prohémostatiques, acide tranexamique et rFVIIa ou PPSB dans les 48h précédant l’inclusion
    •Administration de CGRs dans les 3 mois précédant l'inclusion
    •Participation à un autre essai clinique interventionnel dans les 30 jours précédant l’inclusion
    •Patiente déjà incluse dans cet essai
    •Antécédent connu d’hypersensibilité ou autre réaction sévère à l’un des composants du Clottafact ou du placebo
    •Mineures, majeures sous tutelle, personnes séjournant dans un établissement sanitaire ou social et personnes privées de liberté
    •Antécédents d’alcoolisme ou de toxicomanie connus
    •Patiente recevant un traitement risquant d’interférer dans l’interprétation des résultats
    •Patiente présentant toute autre pathologie qui pourrait interférer avec l’évaluation du traitement selon le jugement de l’investigateur
    •Patientes dont la survie à la période de traitement et d’évaluation est peu probable
    •Patientes transférées d'un autre service
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients losing at least 4 g/dl of Hb, and/or requiring the transfusion of at least 2 units of packed RBCs within the 48 hours following the administration of IMP.
    The reference for Hb level is the most recent value recorded during the third trimester of pregnancy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48h following the IMP administration.
    E.5.2Secondary end point(s)
    - Evolution of haemorrhage
    oPercentage of patients losing at least 4 g/dL of Hb, 48 hours following IMP administration with regards to the Hb reference level.
    oPercentage of patients losing at least 3 g/dL of Hb, 48 hours following the IMP administration with regards to the Hb reference level.
    oPercentage of patients requiring the transfusion of at least 2 units of packed RBCs, 48 hours following the IMP administration.
    oPercentage of patients losing at least 4 g/dL of Hb, 48 hours following the IMP administration with regards to the Hb level measured at inclusion.
    oPercentage of patients with an occurrence of Hb level < 9 g/dL within the 48 hours period following inclusion.
    oNumber of units of transfused blood products within the 48 hours period following the IMP administration.
    oCalculated volume of total blood loss, 48 hours following the IMP administration.

    - Need for haemostatic intervention
    oPercentage of patients requiring at least one of the following interventions within 48 hours following the administration of IMP: uterine ligation (B Lynch or other techniques), pelvic arteries embolization, surgical vascular ligation, administration of recombinant activated Factor VII (rFVIIa) and hysterectomy.

    - Maternal morbi-mortality
    oLength of stay in resuscitation and/or intensive care and/or PICU and/or continuous care
    oLength of stay in obstetrics units
    oSingle or multi-organ failure (SOFA) score in women transferred to resuscitation and/or intensive care and/or PICU and/or continuous care units
    oDeath during the study

    - Evolution of blood fibrinogen level after early administration
    oChange in plasma fibrinogen level between H0 (start of IMP infusion) and D2.

    - Evolution of hemoconcentration
    oChange in Hb level between each determination and H0
    oChange in Ht level between each determination and H0
    oChange in RBCs count between each determination and H0
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints of evaluation of secondary endpoints are variable and are defined for each endpoint.
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 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 concerned15
    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 last 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 months2
    E.8.9.1In the Member State concerned 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: 434
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    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 state434
    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)
    usual treatment
    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 Decision2013-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-06
    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-Fri Apr 26 05:15:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA