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   43857   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:2012-005511-11
    Sponsor's Protocol Code Number:SPON1155-12
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-005511-11
    A.3Full title of the trial
    Fibrinogen concentrate versus placebo for treatment of postpartum haemorrhage: a prospective double blind randomised control trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fibrinogen concentrate to treat bleeding at the time of childbirth
    A.3.2Name or abbreviated title of the trial where available
    Fibrinogen concentrate to treat postpartum haemorrhage
    A.4.1Sponsor's protocol code numberSPON1155-12
    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 SponsorRACD Cardiff University
    B.1.3.4CountryUnited Kingdom
    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 supportCSL Behring GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSouth East Wales Trials Unit (SEWTU, Cardiff University
    B.5.2Functional name of contact pointJacqueline Nuttall
    B.5.3 Address:
    B.5.3.1Street Address7th Floor, Neuadd Meirionnydd, Heath Park
    B.5.3.2Town/ cityCardiff
    B.5.3.3Post codeCF24 ODE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(029)20687295
    B.5.5Fax number+44(029)20687612
    B.5.6E-mailNuttallJ@cf.ac.uk
    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 RiaSTAP (bulk product)
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameRiaSTAP (bulk product)
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFibrinogen
    D.3.9.1CAS number PL15036/0033
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1 to 1
    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) 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 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 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 haemorrhage
    E.1.1.1Medical condition in easily understood language
    Bleeding at the time of childbirth
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 14.1
    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 14.1
    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 14.1
    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
    This study aims to establish whether giving fibrinogen (one of the body's blood clotting factors and it plays an important role is forming a strong clot) to women who are bleeding during childbirth and who have a low fibrinogen, reduces blood loss and reduces the amount of blood transfusion that women require.
    E.2.2Secondary objectives of the trial
    Secondary objectives (i) To explore the effect of fibrinogen concentrate infusion on following efficacy endpoints: - the proportion of women receiving blood products within 24 hours after study medication - the number of units of red cell, fresh frozen plasma, cryoprecipiate and platelets transfused within 24 hours after study medication - the measured blood loss within 24 hours after study medication - the proportion of women requiring cryoprecipitate or fibrinogen concentrate as subsequent therapy within 24 hours after study medication - the proportion of women requiring invasive procedures (return to theatre, uterine brace sutures, uterine tamponade balloons, radiology intervention and hysterectomy) and the time of this intervention within 24 hours after study medication - Incidence and duration of breastfeeding (ii) To explore the effect of fibrinogen concentrate infusion on following safety endpoints: - the proportion of women requiring ITU/HDU admission and length of
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria 1) Women Age 18 years or over 2) Women should have any one of the following within the first 12 hours after delivery: a) Haemorrhage of about 1500 mL and ongoing bleeding without another complication or b) Haemorrhage of about 1000 mL and ongoing bleeding with any of: i. caesarean section ii. uterine atony iii. placental abruption iv. placenta praevia v. Cardiovascular instability (arterial blood pressure below 90mm/Hg and heart rate greater than 100 bpm) vi. Clinical observation of microvascular oozing NB. Women can be included if they fulfill the inclusion criteria after delivery of the baby but where the bleeding had started in the antenatal period (antepartum haemorrhage). Women can be included where there is a slow accumulation of on-going blood loss (in the first 12 hours after delivery) if they fulfill the inclusion criteria. Participants will be eligible for randomisation and entry into the interventional phase of the study if there are both • On-going bleeding and • FIBTEM MCF < 18mm
    E.4Principal exclusion criteria
    Exclusion criteria The following groups will be excluded: 1) Women who have stated that they do not want to participate in the study during the antenatal period 2) Women declining infusion of red blood cells or blood components 3) Known inherited bleeding disorder 4) Placenta accreta diagnosed antenatally 5) Women who have already received uterine brace sutures, uterine tamponade balloons, radiology intervention or hysterectomy before entering the study 6) Clinical suspicion of amniotic fluid embolism 7) Secondary postpartum haemorrhage (haemorrhage which starts >12 hours after delivery)
    E.5 End points
    E.5.1Primary end point(s)
    This is a randomised double blind study comparing fibrinogen concentrate versus placebo. The primary outcome measure will be to compare: The total number of units of allogeneic blood products (red blood cells + fresh frozen plasma + cryoprecipitate + platelets) transfused within 24 hours after study medication between the two arms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evalated at 24 hours after the study drug has been administered.
    E.5.2Secondary end point(s)
    Efficacy endpoints: the proportion of women receiving no transfusion of allogeneic blood products within 24 hours after study medication the number of units of red blood cells, fresh frozen plasma, platelets and cryoprecipitate transfused within 24 hours after study medication the measured blood loss within 24 hours after study medication the proportion of women requiring cryoprecipitate or fibrinogen concentrate as subsequent therapy within 24 hours after study medication the proportion of women requiring invasive procedures (return to theatre, uterine brace sutures, uterine tamponade balloons, radiology intervention and hysterectomy) and the time of this intervention within 24 hours after study medication Safety endpoints: the proportion of women requiring ITU/HDU admission and length of stay the length of total hospital stay psychological impact of PPH on mothers' well being and breastfeeding rate (assessed by interview at 6 weeks follow up) the incidence of clinically diagnosed arterial and venous thromboembolism at 6 weeks follow up
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated between the time the study drug has been administered and 6 weeks.
    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 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 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 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 concerned3
    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
    For the purpose of regulatory requirements the end of the trial is defined as the date of the last 6 week follow up for the last participant undergoing protocol treatment. For the purpose of the research ethics committee the study end date is deemed to be the date of last data capture.
    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 months4
    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 months4
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1050
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 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 state1050
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1050
    F.4.2.2In the whole clinical trial 1050
    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)
    Normal treatment will apply after the infusion of fibrinogen/placebo.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Cardiff University
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-26
    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 14:01:23 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA