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    Summary
    EudraCT Number:2005-000891-42
    Sponsor's Protocol Code Number:NN1731-1668
    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:2005-07-08
    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 number2005-000891-42
    A.3Full title of the trial
    A randomised, open-label, multi-centre trial investigating the intra-subject variability of ROTEM® and TEG® parameters following two intravenous administrations of the same dose of activated recombinant factor VII (rFVIIa/NovoSeven®) in haemophilia patients in a non-bleeding state
    A.4.1Sponsor's protocol code numberNN1731-1668
    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 Information not present in EudraCT
    D.2.1.1.1Trade name NovoSeven
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameNovoSeven®
    D.3.4Pharmaceutical form Powder and solvent 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 INNeptacog alfa (activated)
    D.3.9.1CAS number 102786-61-8
    D.3.9.3Other descriptive nameBlood-coagulation factor VIIa; Human recombinant coagulation factor VIIa
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Haemophilia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10061992
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the intra-subject variability (in vivo reproducibility) of thromboelastographic parameters as measured by ROTEM® and by TEG® prior to and at 15, 60, 120 and 240 minutes following two administrations of the same dose of activated recombinant human FVII (rFVIIa) in haemophilia patients in a non bleeding state
    E.2.2Secondary objectives of the trial
    • To evaluate whether there is a correlation between different doses of rFVIIa and the ROTEM® and TEG® parameters
    • To evaluate whether there is a correlation between thromboelastographic parameters as determined by ROTEM® and by TEG®
    • To compare the in vivo reproducibility of thromboelastographic parameters as determined by ROTEM® and by TEG®
    • To evaluate the inter-subject variability of thromboelastographic parameters as measured by ROTEM® and by TEG®
    • To evaluate whether there is a correlation between the response of in vivo and ex vivo supplementation of rFVIIa
    • To evaluate whether there is a correlation between the in vivo ROTEM® or TEG® parameters and the following parameters FVIIa:C, FX:C, Fibrinogen, Number of platelets and total platelet volume, PT and aPTT
    • To evaluate the safety of rFVIIa administration
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the patient.)
    • Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C or FIX:C one stage activity, respectively, at less than 5% of normal (based on medical records) +/- inhibitors (a positive inhibitor status defined as >0.6 Bethesda units)
    • Male subjects, 16 years of age or more
    • Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product
    E.4Principal exclusion criteria
    • Known or suspected allergy to trial product or any of its components or to related products
    • Previous participation in this trial defined as randomisation of the patient
    • Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B
    • Platelet count < 50,000 platelets/μL
    • Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for rFVIIa
    • Received rFVIIa within the last 48 hours prior to administration of trial product
    • Participation in any other trial involving investigational products within the last 30 days prior to administration of trial product
    • Received immunosuppressive-immunomodulatory drugs within the last 30 days prior to administration of trial product
    • Advanced atherosclerotic disease, incl. any history of thrombotic disorder (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke or peripheral arterial thrombosis)
    • Septicaemia, e.g. febrile illness within 5 days prior to trial product administration
    • Renal insufficiency defined as current dialysis therapy or creatinine levels above normal range (according to local laboratory range)
    • Hepatic disease
     Patients with significant hepatic enzyme elevation (ALAT x 2 upper reference limit and/or PT<70%)
     Known current hepatic dysfunction or severe hepatic disease during the last 12 months.
    • Any disease or condition which, according to the Investigator´s judgement, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
    • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints
    • TEG® parameters (R time, K time, α, MA and LY30) prior to and at 15, 60, 120, 240 minutes after dosing of rFVIIa
    • ROTEM® parameters (CT, CFT, α, MCT and LI60) prior to and at 15, 60, 120, 240 minutes after dosing of rFVIIa

    Secondary endpoints
    • TEG® parameters (R time, K time, α, MA and LY30) obtained from blood samples spiked ex-vivo with rFVIIa (corresponding to 45, 90 and 180 μg/kg)
    • ROTEM® parameters (CT, CFT, α, MCT and LI60) obtained from blood samples spiked ex-vivo with rFVIIa (corresponding to 45, 90 and 180 μg/kg)
    • FVIIa:C, FX:C, fibrinogen, number of platelets and total platelet volume, PT and aPTT prior to and at 15, 60, 120, 240 minutes after dosing of rFVIIa
    • Serious adverse events regardless of causality and non-serious adverse events judged by the Investigator to be related to trial product administration
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Investigation of TEG® or ROTEM® as a general dose predictive marker(s) in haemophilia
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Intra-subject variability of ROTEM and TEG parameters
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    14 days after last patient’s last visit:
    A telephone interview taking place two weeks after the dosing visits ensures complete adverse event information
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 30
    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 Decision2005-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-05-16
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