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    Summary
    EudraCT Number:2018-003122-88
    Sponsor's Protocol Code Number:SELK2-00005
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-26
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2018-003122-88
    A.3Full title of the trial
    A Phase 2, Randomized, Active Comparator-Controlled, Open-Label, Adaptive Design Study to Assess the Safety and Efficacy of Intravenously-Administered SelK2 in Patients Undergoing Total Knee Arthroplasty
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, controlled study to evaluate safety and efficacy of SelK2 in patients undergoing total knee replacement.

    A.4.1Sponsor's protocol code numberSELK2-00005
    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 SponsorTetherex Pharmaceuticals Corporation
    B.1.3.4CountryUnited States
    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 supportTetherex Pharmaceuticals Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTetherex Pharmaceuticals Corporation
    B.5.2Functional name of contact pointExecutive Director, Clinical Devel.
    B.5.3 Address:
    B.5.3.1Street Address840 Research Parkway, Suite 512
    B.5.3.2Town/ cityOklahoma City
    B.5.3.3Post codeOK 73104
    B.5.3.4CountryUnited States
    B.5.4Telephone number001919819-2112
    B.5.6E-mailjstocker@tetherex.com
    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 nameSelK2
    D.3.4Pharmaceutical form Solution for 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 INNSelK2
    D.3.9.2Current sponsor codeSelK2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    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.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 Enoxaparin
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Belgium
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    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 SODIUM
    D.3.9.1CAS number 9041-08-1
    D.3.9.4EV Substance CodeSUB11933MIG
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Venous thromboembolism occurring in patients undergoing total knee replacement arthroplasty
    E.1.1.1Medical condition in easily understood language
    Blood clots in the leg occurring in patients undergoing total knee replacement
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10051055
    E.1.2Term Deep vein thrombosis
    E.1.2System Organ Class 10047065 - Vascular disorders
    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 the efficacy of SelK2 as monotherapy for the prevention of VTE (venous thromboembolism) (composite of asymptomatic DVT (deep vein thrombosis) detected by mandatory unilateral venography of the operated leg or confirmed symptomatic DVT, confirmed symptomatic PE (pulmonary embolism) or unexplained death) in patients undergoing primary unilateral TKA.
    - To assess the incidence of bleeding events (major bleeding events, clinically relevant nonmajor bleeding events, and minor bleeding events) in patients administered SelK2 and undergoing primary unilateral TKA.
    - To assess the overall safety and tolerability of SelK2 in this patient population.

    Adaptive Arm (SelK2 given concomitantly with enoxaparin; SelK2, 7.5 mg/kg, IV and enoxaparin, 40 mg, SC, QD):
    -Assess the efficacy and safety of SelK2 when given in addition to enoxaparin for the prevention of VTE in patients undergoing primary unilateral TKA
    E.2.2Secondary objectives of the trial
    - To further describe the PK and PD of SelK2.
    - To evaluate the immunogenicity of single dose SelK2.
    - To evaluate exploratory efficacy endpoints of inflammation and thrombosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females, between 18 and 80 years of age, inclusive;
    2. Females must be non-pregnant and non-lactating, and either postmenopausal (>12 months since last menses) or using highly effective contraceptive measures as defined in the Clinical Trial Facilitation Group (CTFG) guidelines*;
    3. Males, if engaged in sexual relations with a partner of child-bearing potential, must use highly effective contraceptive measures as defined in the Clinical Trial Facilitation Group (CTFG) guidelines;
    4. Planned to undergo elective, primary total unilateral TKA under general anesthesia; and
    5. Able to comprehend and willing to give written informed consent.
    E.4Principal exclusion criteria
    1. Body weight <50 kg at Screening;
    2. Previous deep vein thrombosis (DVT) of the leg or pulmonary embolism (PE) within the past year;
    3. Malignancy within 1 year, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated;
    4. Myocardial infarction, transient ischemic attack or stroke within the last 6 months;
    5. Patients at increased risk of bleeding because of history of increased bleeding tendency (i.e., history of bleeding diathesis) or any other condition that in the opinion of the Investigator increases risk of bleeding (e.g., recurrent gastrointestinal ulcer) or patients with a history of intracranial or intraocular bleeding;
    6. Brain, spinal, or ophthalmologic surgery within the past 3 months;
    7. Cockcroft-Gault calculated creatinine clearance <30 mL/min at Screening (central lab will calculate the Cockcroft-Gault value);
    8. Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values that, in the opinion of the PI, would render a patient unsuitable for inclusion:
    - ALT or AST >1.5x ULN
    - Total bilirubin >1.5x ULN
    - Platelet count <150,000 or recent (over the last 3 months) history of thrombocytopenia (e.g. platelet count <150,000);
    9. Positive test for human immunodeficiency virus (HIV; by history of having HIV antibodies), positive hepatitis B (hepatitis B surface antigen [HBsAg]) or hepatitis C (antihepatitis C antibody [Anti-HCV]) at Screening;
    10. Uncontrolled hypertension as judged by the Investigator;
    11. Clinically significant abnormal ECG at Screening, as judged by the Investigator;
    12. Active infection;
    13. Unable to undergo venography due to a known allergy to the contrast agent, anticipated poor venous access, impaired renal function, or any other reason identified and specified by the PI;
    14. Hypersensitivity to enoxaparin or any contraindication listed in the local labeling of enoxaparin;
    15. Any underlying condition (e.g., atrial fibrillation, mechanical heart valve, or recent pulmonary embolism) that may lead to the required concomitant use of anticoagulants/antiplatelet agents (e.g., warfarin, dabigatran, rivaroxaban, apixaban, clopidogrel) that may affect study outcome or any other drug influencing coagulation (except low dose aspirin (100 mg or less));
    16. Anticipated use of intermittent pneumatic compression devices and/or electrical/mechanical muscle stimulators post TKA procedure;
    17. Anticipated use of indwelling intrathecal or epidural catheters;
    18. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 60 days prior to Day 1;
    19. History of alcoholism or drug addiction within 1 year prior to Screening;
    20. Any acute or chronic condition that, in the opinion of the Investigator, would limit the patient’s ability to complete and/or participate in this clinical study; or
    21. Unwillingness to comply with all study procedures including follow-up visits, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The incidence of total venous thromboembolism will consist of a composite of:
    - Asymptomatic deep-vein thrombosis of the operated leg (detected by mandatory unilateral venography);
    - confirmed symptomatic DVT of the leg(s);
    - confirmed symptomatic pulmonary embolism; and
    - unexplained death for which pulmonary embolism could not be ruled out.
    E.5.1.1Timepoint(s) of evaluation of this end point
    See protocol
    E.5.2Secondary end point(s)
    • The incidence of total bleeding events categorized as:
    - Major Bleeding event (MB),
    - Clinically Relevant Non-Major Bleeding event (CRNMB),
    - Minor Bleeding.
    • Laboratory Markers of Inflammation and Thrombosis. Absolute changes from baseline in levels of high sensitivity C-reactive Protein (hsCRP) and D-dimer will be assessed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See protocol
    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 Yes
    E.8.1.7.1Other trial design description
    Adaptive
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Enoxaparin
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Latvia
    Lithuania
    Poland
    Ukraine
    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
    LSLV
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 190
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 95
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 202
    F.4.2.2In the whole clinical trial 285
    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)
    The IMP will not be available after the clinical trial has ended.
    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 Decision2018-12-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-14
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