A Phase 2, controlled study to evaluate safety and efficacy of SelK2 in patients undergoing total knee replacement.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 285

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) no
F.1.3.1 Number of subjects for this age range 95

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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