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    Summary
    EudraCT Number:2013-003532-68
    Sponsor's Protocol Code Number:FIBCON
    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:2014-02-14
    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 number2013-003532-68
    A.3Full title of the trial
    Fibrinogen concentrate supplementation in the management of bleeding during paediatric cardiopulmonary bypass: a phase 1B/2A, open label dose escalation study (Version 1.0, Jan 28, 2014)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fibrinogen concentrate supplementation for infants undergoing heart surgery with cardiopulmonary bypass
    A.3.2Name or abbreviated title of the trial where available
    FIBCON: Fibrinogen concentrate in paediatric cardiopulmonary bypass
    A.4.1Sponsor's protocol code numberFIBCON
    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 SponsorGuy's and St Thomas NHS Foundation Trust
    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 Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's and St Thomas' NHS Foundation Trust
    B.5.2Functional name of contact pointDr Shane Tibby
    B.5.3 Address:
    B.5.3.1Street AddressPICU F 02, Evelina Children’s Hospital, Westminster Bridge Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number440207188 4572
    B.5.5Fax number440207188 4570
    B.5.6E-mailshane.tibby@gstt.nhs.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
    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.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Fibrinogen (Riastap)
    D.3.9.1CAS number 9001-32-5
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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
    Neonates and infants who are at risk of mediastinal bleeding following cardiopulmonary bypass surgery for congenital heart disease
    E.1.1.1Medical condition in easily understood language
    Babies and young infants (<12kg) with congenital heart disease who require major heart surgery using cardiopulmonary bypass, and are thus at risk of postoperative bleeding from within the chest
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10055817
    E.1.2Term Haemorrhage intrapericardial
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10010495
    E.1.2Term Congenital heart disease NOS
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the dose of intraoperative human fibrinogen concentrate required to achieve physiological levels of fibrin polymerization of 8 to 13 mm as measured by the ROTEM measure of fibrin-based clotting: FibTEM MCF (equating to plasma fibrinogen concentrations of 1.5 to 2.5 g/L), immediately prior to separation from cardiopulmonary bypass in
    neonates and children < 12kg
    E.2.2Secondary objectives of the trial
    (a) To provide preliminary efficacy and safety data following human fibrinogen concentrate administration
    (b) To document ROTEM profiles intra- and post-operatively
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    i) Congenital heart disease requiring non-emergency* surgery on cardiopulmonary bypass
    ii) Age range: > 36 weeks corrected gestation
    iii) Weight 2.5 – 12 kg
    iv) Informed consent to participate
    *Non-emergency is defined as surgery that can be delayed >24 hours following diagnosis of congenital heart disease
    E.4Principal exclusion criteria
    i) Known pre-existing inherited coagulopathy
    ii) Known pre-existing inherited thrombophilia
    iii) Recent, acute (within previous 2 weeks) thrombosis in a major vessel or thrombotic-related major complications (as defined in sections 2.43 and 7.3)
    iv) Administration of antiplatelet agents (e.g. aspirin) <48 hrs prior to surgery
    v) Known hypersensitivity / allergy to study drug or similar products
    vi) History of anaphylaxis
    vii) Enrolment in another clinical trial in the previous 3 months
    viii) Parent/guardian unable to provide informed consent (this can include insufficient understanding of the trial, as judged by the clinician taking consent)
    ix) major co-morbidity likely to increase risk of mortality from surgical procedure
    x) significant renal/liver impairment within 2 days of planned surgery (creatinine > 2x ULN, ALT > 2x ULN)
    E.5 End points
    E.5.1Primary end point(s)
    Fibrinogen concentration and Fib-TEM MCF measured within 5 minutes of completion of IMP administration
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 5 minutes of completion of IMP administration
    E.5.2Secondary end point(s)
    (ACTIVE and MONITORING arms)
    Efficacy
    •Mediastinal drain losses in first 24 hours after PICU admission
    • Requirement for delayed sternal closure due to clinical bleeding / tamponade
    •Requirement for ancillary blood transfusions in first 24 hours after PICU admission
    •Use of intra- and post-operative ancillary clotting products (as per transfusion algorithm)
    •Fibrinogen levels and ROTEM variables T4 – T6
    Safety
    #Incidence of major thrombotic event / thromboembolic-associated complications
    •surgical shunt occlusion
    •imaging evidence of intracardiac/major vessel thrombosis up to discharge or day 30 post operative
    •Stroke from sinovenous thrombosis or arterial ischaemia of cardioembolic origin
    •Pulmonary embolism
    •Superior vena cava syndrome
    •Thrombotic vessel obstruction requiring active treatment with:
    thrombolysis/mechanical intervention (open thrombectomy, cardiac catheter)
    •Cardiopulmonary arrest associated with thrombosis
    #allergic / hypersensitivity reaction to study drug
    E.5.2.1Timepoint(s) of evaluation of this end point
    All safety analyses will be up to hospital discharge or day 30 post operative (whichever comes first).

    The remaining endpoints will be evaluated up to 24 hours after (Paediatric Intensive Care Unit (PICU) admission with Fibrinogen levels and ROTEM variables evaluated at timepoints T4 - T6.
    T4: at Paediatric intensive care Unit (PICU) admission
    T5: 4hrs after PICU admission
    T6: 24hrs after PICU admission
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.3Single blind No
    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 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 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
    LVLS (90th patient in the ACTIVE arm)
    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
    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: 90
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 90
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 90
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Neonates and infants
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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 - single dose only
    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 Medicines For Children Research Network (MCRN)
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-29
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