Venous thromboembolism occurring in patients undergoing total knee replacement arthroplasty MedDRA version: 20.0 Level: PT Classification code 10051055 Term: Deep vein thrombosis System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Name: SelK2
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Selk2
Other descriptive name: Selk2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Conc
Sponsors
Tetherex Pharmaceuticals Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 190 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 95
Exclusion criteria
Exclusion criteria: 1. Body weight 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 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;Secondary Objective: - 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.;Primary 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.;Timepoint(s) of evaluation of this end point: See protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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. ;Timepoint(s) of evaluation of this end point: See protocol | — |
Countries
Bulgaria, Latvia, Lithuania, Poland, Ukraine
Contacts
Public ContactExecutive Director, Clinical Devel.
Tetherex Pharmaceuticals Corporation
Outcome results
None listed