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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2008-006324-62
    Sponsor's Protocol Code Number:NN1810-3540
    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:2009-03-26
    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 number2008-006324-62
    A.3Full title of the trial
    A Multi-Centre, Randomised, Double-Blind, Placebo
    Controlled Trial on Efficacy and Safety of FXIII
    Replenishment with two different Doses of Recombinant
    Factor XIII following Cardiopulmonary Bypass Surgery
    A.4.1Sponsor's protocol code numberNN1810-3540
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameRecombinant Factor XIII (rFXIII)
    D.3.2Product code NN1810
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCatridecacog
    D.3.9.1CAS number 606138-08-3
    D.3.9.3Other descriptive nameRecombinant Factor XIII (rFXIII)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    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 placeboPowder for solution 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
    Aquired FXIII deficiency following cardiopulmonary bypass surgery (CABG (coronary atery bypass grafting) or CABG plus single heart valve replacement/repairs or planned replacement/repair of a single heart valve)

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063919
    E.1.2Term Bypass surgery
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether postoperative treatment with either of two doses (17.5 or 35 IU/kg LBM) of recombinant factor FXIII (rFXIII) is effective in avoiding any allogeneic transfusions in cardio pulmonary bypass (CPB) surgery subjects with a pre-operative transfusion risk score of 2 or 3
    E.2.2Secondary objectives of the trial
    To document the safety profile of rFXIII used as replenishment therapy in cardiopulmonary bypass (CPB) surgery.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent (IC) obtained before any trial-related activities. (Trial related activities are any procedure that would not have been performed during the normal management of the subject).
    2. Age: ≥ 18 - ≤ 80 years
    3. Subjects scheduled to undergo cardiac surgery (CS) requiring CPB
    4. Planned:
    • CABG or
    • CABG plus single heart valve replacement/repair or
    • planned replacement/repair of a single heart valve
    5. Pre-operative transfusion risk score of 2 or 3 (Table 3–1 in protocol)
    6. Peri-operative use of an antifibrinolytic agent
    E.4Principal exclusion criteria
    1. Known or suspected allergy to trial drug(s) or related products
    2. Known intolerance to protamine
    3. Known or suspected allergy to the used antifibrinolytic agent
    4. Previous randomisation and dosing in this trial
    5. The receipt of any investigational drug within 30 days prior to surgery
    6. Refusal to receive blood or blood product
    7. Planned off pump coronary artery bypass (OPCAB)
    8. Planned peri-operative use of Desmopressin (DDAVP)
    9. Known heparin induced thrombocytopenia (HIT)
    10. Known deficiency of protein C, protein S, antithrombin, or homozygous Factor V Leiden
    11. Known congenital bleeding disorders
    12. Planned surgery including the aortic arch and/or descending aorta
    13. Planned surgery including any implantable ventricular assist device
    14. Adult congenital heart diseases
    15. Current endocarditis
    16. Planned deep hypothermic circulatory arrest (< 28°C)
    17. Two or more previous cardiac surgery procedures
    18. Emergency cardiac surgery procedures i.e. those that are medically required within 24 hours of presenting with acute symptoms
    19. Planned CPB priming with red blood cells (RBC)
    20. Any known autoimmune diseases:
    • Collagen vascular disease (Systemic lupus erythematosus, Rheumatoid arthritis, Sjögren's syndrome)
    • Endocrine: hyperthyroidism (Grave's disease), adrenal insufficiency, Hashimoto's
    thyroiditis
    • Neurologic: Multiple sclerosis, myasthenia gravis
    • Skin: pemphigus vulgaris
    • Hematologic: Pernicious anaemia, Autoimmune haemolytic anaemia
    • Vasculitis
    • Primary or secondary antiphospholipid syndrome
    21. Any history of stroke or non-coronary thrombotic disorders including deep venous thrombosis (DVT) and pulmonary embolism (PE)
    22. Heart failure classified as New York Heart Association (NYHA) ≥ III
    23. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
    24. Confirmed acute myocardial infarction (AMI) within 7 days
    25. Pre-operative platelet count < 100,000/microliter
    26. BSA < 1.9 m² and anaemia: (haematocrit (Hct.) < 36% (f) / Hct. < 39% (m))
    27. Dosed with clopidogrel or other adenosinephosphate (ADP) receptor antagonists within the last three days prior to surgery
    28. Dosed with GPIIb/IIIa receptor blockers (Abciximab, Tirofiban, Eptifibatide) ≤ 24 hours prior to surgery
    29. International Ratio (INR) > 1.5 on the day of surgery in patients treated with vitamin K antagonist
    30. Liver dysfunction (aspartate aminotrasferase (AST) or alanine aminotransferase (ALT) increased ≥ 2-fold above the upper limit of local laboratory normal ranges)
    31. Renal failure (creatinine ≥ 175 micromol/L or dialysis)
    32. Most recent left ventricular ejection fraction < 30%
    33. Current thromboembolic disease other than myocardial infarct
    34. Planned peri-operative use of fibrin sealants
    35. Use of any investigational agent
    36. Weight ≥ 140 kg
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects avoiding any allogeneic transfusions (RBC, FFP, platelets, cryoprecipitate, fibrinogen concentrate, clotting factor concentrate) for seven days post-operative or until discharge, whichever comes first.
    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 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 287
    F.4.2.2In the whole clinical trial 460
    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 Decision2009-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-23
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