Phase 2
N=207
Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement
Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT03812328 ↗Enrolled (actual)
207
Serious AEs
3.4%
Results posted
Nov 2020
Primary outcome: Primary: Percentage of Participants With Total Venous Thromboembolism — 19; 29; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SelK2 (Drug); Enoxaparin (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tetherex Pharmaceuticals Corporation
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Total Venous Thromboembolism |
19; 29; 17 | — |
| PRIMARY Percentage of Participants With Major or Clinically Relevant Non-major Bleeding Events |
2; 1; 0 | — |
Summary
The main purpose of this study is to determine if an investigational medication called SelK2 works in preventing a condition called "venous thromboembolism" (VTE) in patients having a total knee replacement. SelK2 has been designed to attach to a protein found on blood cells and blood vessels. By attaching to this protein, SelK2 is designed to decrease the inflammatory process in the blood vessel wall that leads to the formation of blood clots in the vessel (called thrombosis). By decreasing the inflammatory process, SelK2 may reduce the risk of VTE following joint replacement surgery. In addition, because SelK2 is not a blood thinner, it is expected that the risk for bleeding will also be reduced.
Eligibility Criteria
Key Inclusion Criteria
- Males or females, 18-80 years of age (inclusive)
- Planned to undergo elective, primary total unilateral Total Knee Arthroplasty under general anesthesia
Key Exclusion Criteria
- Previous deep vein thrombosis (DVT) of the leg or pulmonary embolism (PE) within the past year
- 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))
- Anticipated use of intermittent pneumatic compression devices and/or electrical/mechanical muscle stimulators post Total Knee Arthroplasty procedure
Data sourced from ClinicalTrials.gov (NCT03812328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.