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    Summary
    EudraCT Number:2009-017736-41
    Sponsor's Protocol Code Number:2009-315
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-09
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2009-017736-41
    A.3Full title of the trial
    "Fibrinogen-koncentrat som initial behandling ved postpartum blødning"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment to enhance the blood ability to clot in case of haemorrhage following child birth
    A.3.2Name or abbreviated title of the trial where available
    [FIB∙PPH]-studiet
    A.4.1Sponsor's protocol code number2009-315
    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 SponsorAnæstesiologisk Afd. Herlev Hospital
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHerlev Anæstesiologisk Afdeling
    B.5.2Functional name of contact pointAnne Juul Wikkelsø
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.4Telephone numberDanma22612152
    B.5.6E-mailwikkelso@gmail.com
    D. IMP Identification
    D.IMP: 1
    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 Haemocomplettan / Riastap
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameFibrinogen koncentrat
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 9001-32-5
    D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postpartum blødning
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10036296
    E.1.2Term Postpartum haemorrhage NOS
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10036294
    E.1.2Term Postpartum haemorrhage (primary)
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10043454
    E.1.2Term Third-stage postpartum haemorrhage
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10036417
    E.1.2Term Postpartum haemorrhage
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10055864
    E.1.2Term Other immediate postpartum haemorrhage, postpartum
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10043449
    E.1.2Term Third stage postpartum haemorrhage
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Dette forsøg har til formål at se på effekt og bivirkninger af tidlig (up-front) administreret fibrinogen-koncentrat hos patienter med postpartum blødning.

    Hypotese:
    Fibrinogen-koncentrat versus placebo administreret initialt ved postpartum blødning reducerer behovet for transfusion med blodprodukter. Rationalet bag er at et sufficient niveau af fibrinogen, der fungerer som substrat for koagulationsprocessen, vil bedre hæmostasen hos den fødende med konstateret PPH.
    E.2.2Secondary objectives of the trial
    Se på effekten af fibrinogen i forhold til følgende effektparametre.
    Udvikling af "svær postpartum blødning" defineret som:
    "Peripartum fald i Hgb på > 2,5 mmol/L (sidste Hgb værdi før fødsel som reference), Transfusion af mindst 4 enheder røde blodlegemer (SAGM), Hæmostatisk intervention (angiografisk embolisering, kirurgisk arteriel ligering eller hysterektomi) eller Død. Estimeret blodtab, Transfusionsbehov Per- og postoperativt, 24 timer, 7 dage og 30 dage (Samlet, SAGM, FFP, trombcytter, kryopræcipitat),
    Multitransfusion (>5 SAGM), Sekundær PPH (vaginal blødning efter 24 timer til 42 dage efter fødsel), Incidensen af kirurgisk reintervention pga. blødning.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Delprojekt 1:
    Titel: Værdien af tidlig koagulopati-screening ved postpartum blødning.
    Metode: Prospektivt observationelt studie med laboratoriedata fra [FIB-PPH]-studiet.
    Formål: At belyse den prædiktive værdi af tidlig diagnosticeret koagulopati ved PPH. Samt sammenligne værdien af standard laboratorie koagulationstal og thrombelastografi (TEG).

    Delprojekt 2:
    Titel: Transfusions praksis ved postpartum blødning.
    Metode: Retrospektiv data-gennemgang 2000-2009
    kombineret med prospektive data fra [FIB-PPH]-studiet.
    Formål: At deskriptivt redegøre for transfusionspraksis og forekomst af multitransfusion ved PPH. At belyse sammenhængen mellem en balanceret transfusionsterapi og sværhedsgraden af PPH.

    (De fulde protokoller til disse delprojekter er vedlagt ansøgningen)
    E.3Principal inclusion criteria
    PPH defineret som blødning fra uterus og/eller fødselskanalen opstået indenfor de første 24
    timer efter fødsel. Alder ≥ 18 år. Samtykke fra patient eller forsøgsværge.
    Vaginal forløsning: Ved indikation for ét af følgende postnatale indgreb udført på operationsgangen med
    anæstesiologisk assistance:
    i. Ved estimeret blodtab ≥ 500 ml og indikation for manuel placentafjernelse.
    ii. Ved manuel eksploration af uterus på grund af blødning efter placentas fødsel.
    Forløsning ved sectio: Peroperativt blodtab ≥1000 ml.
    E.4Principal exclusion criteria
    Patienter med kendt medfødt koagulationsdefekt.
    Patienter, der præpartum er i behandling med antitrombotiske midler: AK- behandling (Warfarin), trombocythæmmende midler (Clopidogrel og Acetylsalicylsyre), lavmolekulært heparin (LMWH). Omfattende terapeutiske såvel som profylaktiske doser.
    Patienter med en prægraviditetsvægt
    < 45 kg.
    Patienter der på forhånd modsætter sig blodtransfusion.
    E.5 End points
    E.5.1Primary end point(s)
    Primært effektmål: Blodtransfusion +/- (allogen blodtransfusion)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 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.8.3 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 concerned4
    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 Information not present in EudraCT
    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
    Forsøget vil blive afbrudt i sin helhed hvis omfanget og alvorligheden af bivirkninger medfører at det ikke vurderes sikkert at fortsætte. Jvf. protokollen.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Postpartum periode: Dvs. ved opstået blødning indtil 24 timer efter fødslen.
    Nogle kvinder vil være akut påvirkede som følge af blødningen, så vi vil derfor anvende forsøgsværgeordning
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state245
    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)
    6 ugers follow up. Ellers intet ud over sædvanligt
    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 Decision2010-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-29
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    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
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