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    Summary
    EudraCT Number:2005-002059-41
    Sponsor's Protocol Code Number:F7Trauma-1711
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-06-09
    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 ConcernedGermany - PEI
    A.2EudraCT number2005-002059-41
    A.3Full title of the trial
    A multi-center, randomized, double-blind, parallel group, placebo controlled trial to evaluate the efficacy and safety of activated recombinant factor VII (rFVIIa/NovoSeven®/NiaStase®) in severely injured trauma patients with bleeding refractory to standard treatment
    A.4.1Sponsor's protocol code numberF7Trauma-1711
    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.2.5The 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.3.2Product code rFVIIa
    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 namerFVIIa, 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 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 and solvent 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
    Traumatic Hemorrhage
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10053476
    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 efficacy and safety of rFVIIa (NovoSeven®/NiaStase®) compared to placebo as an adjunct to standard treatment of trauma patients with active hemorrhage refractory to blood component therapy and surgical hemostatic procedures.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Informed consent (Section 17) obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed as part of the patient’s standard care).
    2.Trauma injury (blunt and/or penetrating) with evidence of active torso (proximal to the inguinal creases, proximal/medial to the axillae) and/or proximal lower extremity (above knee) hemorrhage refractory to blood component therapy and surgical hemostatic procedures at the time of randomization
    3.“Evidence of active hemorrhage (torso and/or proximal lower extremity) at the time of randomization” is defined as:
    a.Presence of hypotension due to hypovolemia (systolic blood pressure (SBP) ≤90 mmHg) documented at any point in time within 30 minutes prior to randomization or
    b.Presence of ongoing volume loading at a minimal rate of 1L/h (RBC or any other IV fluid/blood product) up to the point of randomization (and with continuing similar or greater need per the Investigator's judgment) or
    c.Presence of acidosis (lactate > 6 mmol/L (or 2 times the local upper limit of normal) or Base Deficit ≥ 5 mEq/L) documented at any point in time within 30 minutes prior to randomization
    4.Receipt of a minimum of 4 units of RBC at the time of randomization and the ability to administer first dose of study drug as soon as possible upon the completion of the 4th unit and no later than the completion of the 8th unit of RBC
    5.Male or female patients, between 18-70 years of age OR of legal age to consent for participation in an investigational drug trial as per local law
    E.4Principal exclusion criteria
    1.Moribund as defined by any one of the following (only the most recent values prior to randomization are to be considered):
    a.pH < 7.1* or
    b.Lactate > 15 mmol/l or
    c.Base deficit (BD) > 15 mEq/l or
    d.SBP ≤ 50 mmHg or use of 2 boluses or more of vasopressor or continuous vasopressor treatment to support the blood pressure prior to randomization (bolus vasopressor use for reasons other than hypovolemia (i.e. spinal cord injury, anesthetic induction) does not exclude the patient) or
    e.Anatomical injury incompatible with life (e.g. multiple cardiac wounds, unrepairable liver or pelvic injury) or
    f.Cardiac arrest (cessation of spontaneous circulation) any time from injury prior to randomization.
    2.Evidence of head injury and suspicion of severe brain trauma as defined by any one of the following:
    a.Highest GCS score ≤5 , or
    b.Need for immediate open intracranial operation or
    c.Abnormal physical examination indicative of brain injury (e.g. decorticate posturing, localizing signs such as unequal pupils due to Traumatic Brain Injury) or
    d.Traumatic intracranial injury of AIS > 4 demonstrated by CT scan
    3.Time from injury to dosing > 12 hours
    4.Estimated time of injury to trial hospital admission > 4 hours
    5.Primary bleeding source localized to the upper extremities or distal lower extremities as per the Investigator's judgment
    6.Treatment with aprotinin, aPCC (Activated Prothrombin Complex Concentrate) or PCC (Prothrombin Complex Concentrate)
    7.Known history of thromboembolic events within 30 days
    8.Presence of spinal cord injury above T6 with paralysis
    9.Total body surface area burns: 2° + 3° ≥ 40% (evaluated by the Investigator according to Lund-Browder chart for estimating the extent of burns, Appendix O)
    10.Known or suspected pregnancy
    11.Previous randomization in this trial
    12.Known participation in an investigational drug/device trial within the last 30 days
    13.Estimated body weight < 43 kg
    14.Known or suspected allergy to trial products or related products
    15.Known presence of congenital bleeding disorder
    16.Patient known or suspected of not being able to comply with this study protocol or indication of reluctance to participate in the trial (e.g. revealed by examination of an incapacitated patient's personal effects)

    *In case a low pH value (less than 7.1) is predominantly or partly due to a respiratory component, it is acceptable to assess moribund criterion 1.a. based on a "corrected pH value" calculated from one of the equations:
    In units of mmHg: Corrected pH = actual pH + (0.008 multiplied by each mmHg pCO2 above 40 mmHg). In units of kPa:Corrected pH = actual pH + (0.06 multiplied by each kPa pCO2 above 5.33)
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints:

    Efficacy:
    • A primary endpoint of all cause 30 day mortality designed to show superiority of rFVIIa compared to placebo in blunt trauma patients
    If mortality is not superior, then
    • A primary endpoint designed to demonstrate non-inferiority of rFVIIa compared to placebo on all cause 30 day mortality and superiority of rFVIIa compared to placebo on pulmonary and/or renal dysfunction requiring ongoing medical intervention at Day 30 in blunt trauma patients

    Safety:
    • Adverse events from Randomization through Hour 48 in blunt and penetrating trauma patients
    • Serious Adverse Events (SAEs) from Randomization through Day 90 in blunt and penetrating trauma patients

    Prioritized Secondary Endpoint:

    Efficacy in Blunt Trauma Patients:
    • Days alive and free of pulmonary and/or renal dysfunction requiring ongoing medical intervention through Day 30

    Other secondary endpoints:
    15 minutes after administration of each dose:
    • Assessment of tissue bleeding response

    At 24 hours after the first dose of study drug:
    • Number of transfused units of red blood cells (RBC)
    • Number of transfused units of fresh frozen plasma (FFP)
    • Number of transfused units of platelets
    • Number of transfused units of cryoprecipitate/fibrinogen concentrate
    • Total number transfused allogeneic units

    At 48 hours after the first dose of study drug:
    • Number of transfused units of red blood cells (RBC)
    • Number of transfused units of fresh frozen plasma (FFP)
    • Number of transfused units of platelets
    • Number of transfused units of cryoprecipitate/fibrinogen concentrate
    • Total number of transfused allogeneic units
    • All cause Mortality

    Through Day 30 after the first dose of study drug:
    • Multi organ failure according to Appendix G
    • Single organ failure for pulmonary, renal, cardiovascular, and the hepatic systems
    • Ventilator-free days
    • ICU-free days
    • Hospital-free days

    At Day 30 after the first dose of study drug:
    • Composite endpoint of all-cause mortality and pulmonary and/or renal dysfunction requiring ongoing medical intervention at Day 30
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.5The 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-06-09. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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
    i) Informed Consent by the patient or
    ii) Informed consent by the Patients Legally Authorized Representative or
    iii) Consent obtained according to an enrolment procedure complying with national legislation as described in the Protocol, Section 17
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state570
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2900
    F.4.2.2In the whole clinical trial 5000
    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 Decision2005-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-04
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