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    Summary
    EudraCT Number:2008-004539-39
    Sponsor's Protocol Code Number:TB-402-004
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-14
    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 ConcernedLatvia - SAM
    A.2EudraCT number2008-004539-39
    A.3Full title of the trial
    Single Intravenous Administration of TB-402 for the Prophylaxis of Venous hromboembolic Events (VTE) After Total Knee Replacement Surgery: A Dose-Escalating, Multicenter, Randomised, Active-Controlled Open Label Study
    A.4.1Sponsor's protocol code numberTB-402-004
    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 SponsorThromboGenics N.V
    B.1.3.4CountryBelgium
    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 nameTB-402
    D.3.2Product code TB-402
    D.3.4Pharmaceutical form Solution for infusion
    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.3.9.3Other descriptive nameTB-402
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman recombinant monoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Clexane
    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 nameEnoxaparin
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEnoxaparin
    D.3.9.1CAS number 9005-49-6
    D.3.9.3Other descriptive nameEnoxaparin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typelow molecular weight heparin
    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
    Venous thrombolic events
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049909
    E.1.2Term Venous thromboembolism prophylaxis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the safety and efficacy of a single
    administration of TB-402 for the prevention of VTE in patients undergoing knee
    replacement surgery.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A PK/PD sub study will be performed at selected sites, to develop a more detailed
    understanding of the pharmacokinetics (TB-402 levels) and pharmacodynamics of TB-
    402 (PT, APTT, FVIII). PK/PD blood samples will be collected in 60 patients (15 per
    treatment arm) at screening, day 1, post-infusion day 2, day 7-11, day 35 and day 90. For the patients randomised to enoxaparin, 1 blood sample is to be taken on Day 1; for the patients randomized to TB-402, 2 blood samples are to be taken on Day 1: 1 sample pre- infusion and 1 sample at 2 hours +/- 1 hour after the end of infusion.
    E.3Principal inclusion criteria
    1. Male or female patients aged > 18 and < 80 years old
    2. Female patients should be post menopausal
    3. Patients undergoing primary elective total knee replacement surgery
    4. Written informed consent obtained from the patient (or legally acceptable
    representative) prior to inclusion in the study
    5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests
    and other study procedures
    E.4Principal exclusion criteria
    1. Body weight < 50 kg or > 100 kg
    2. Patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of
    the knee
    3. Confirmed symptomatic deep vein thrombosis or pulmonary embolism within
    the past year
    4. Anticipated use of indwelling intrathecal or epidural catheter for more than 4 h
    after surgery or during the entire study
    5. Uncontrolled hypertension (SBP>160 mm Hg or DBP > 100 mm Hg)
    6. History of intracranial or intraocular bleeding. History of gastrointestinal and/or
    endoscopically verified ulcer disease within the past year
    7. Patients at increased risk of bleeding because of personal history of increased
    bleeding tendency or any other condition that in the opinion of the investigator
    increases risk of bleeding (e.g. documented angiodysplasia, recurrent
    gastrointestinal ulcer)
    8. Clinical laboratory evidence at screening of anemia (haemoglobin level < 10.0
    g/dL) or thrombocytopenia (platelet count < 100X103/μL) or prolonged activated
    partial thromboplastin time (APTT) or prothrombin time (PT) as per local lab
    ranges
    9. Excessive peroperative bleeding and/or active significant postoperative wound
    bleeding as per the investigator’s judgement
    10. Antiplatelet agents other than low dose aspirin < 160mg. The use of
    antithrombotic therapy within 7 days before surgery except for a
    thromboprophylactic dose of LMWH or unfractionated heparin. The use of
    intermittent pneumatic compression.
    11. Patients who require long-term anticoagulant treatment for a comorbid
    condition.
    12. History of significant adverse reaction (e.g. Heparin- or LMWH- induced
    thrombocytopenia) to an anticoagulant
    13. Creatinin clearance <30 mL/min, hypersensitivity to contrast media,
    hypersensitivity to enoxaparin sodium
    14. Active hepatic disease (defined as transaminase >3 X ULN or bilirubin > 1.5
    ULN) or history of hepatic insufficiency
    15. Known drug or alcohol abuse
    16. Active malignant disease or current cytostatic treatment
    17. Participation in an investigational drug study within the past 30 days or previous
    participation in this trial
    18. Any condition which in the opinion of the investigator would put the patient at
    increased risk from participating in the study
    19. Scheduled invasive or surgical procedure within 8 weeks after surgery
    20. Brain, spinal, or ophthalmological invasive surgery within the previous 3 months
    before enrolment
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is; Composite of the occurrence of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE, up to hospital discharge at D 7 – 11.

    The following definitions are applied to assess suspected episodes of PE/DVT:
    Clinically suspected DVT with one of the following findings:
    • an intraluminal filling defect on venography or , an extension of an intraluminal
    filling defect, or a new intraluminal filling defect or an extension of non-visualization
    of veins in the presence of a sudden cut-off on venography, or
    • abnormal compression ultrasound (CUS)
    Clinically suspected PE with one of the following findings:
    • an intraluminal filling defect in segmental or more proximal branches on sCT (spiral
    CT)
    • an intraluminal filling defect or an extension of an existing defect or a new sudden
    cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram,
    • a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scintigraphy
    • inconclusive sCT, pulmonary angiography or lung scintigraphy with demonstration
    of DVT in the lower extremities by compression ultrasound or venography.
    Fatal PE
    • PE based on objective diagnostic testing, autopsy, or
    • death which cannot be attributed to a documented cause and for which PE/DVT
    cannot be ruled out (unexplained death).

    The primary safety endpoint is: The occurrence of total bleeding defined as major and/or clinically relevant non-major bleeding events, from randomisation until the end of the study.
    Major bleeding is defined as acute clinically overt bleeding:
    • associated with a fall in hemoglobin of 2 g/dL (i.e 1.25 mmol/L) or more, or
    • leading to a transfusion of 2 or more units of packed red blood cells or whole blood.
    A red cell unit is defined as the quantity of red cells obtained from or corresponding
    to approximately 500 mL of whole blood, or
    • in a critical site: intracranial, intraspinal, intraocular, pericardial, intraarticular,
    intramuscular with compartment syndrome, retroperitoneal, or
    • that is fatal, or
    • leading to surgical intervention.
    Clinically relevant non-major bleeding is defined as acute clinically overt bleeding not
    meeting the criteria for major bleeding but associated with:
    • excessive wound hematoma or excessive wound bleeding, or
    • medical intervention, or
    • the need for unscheduled contact (visit or telephone call) with a physician, or
    • temporary cessation of a study drug, or
    • discomfort for the patient such as pain or impairment of activities of daily life.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 No
    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
    The end of the trial is defined as the last visit of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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 months6
    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.1.1.1In 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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 300
    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 Decision2008-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-22
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    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
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