Trials / Completed
CompletedNCT03812328
Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- Tetherex Pharmaceuticals Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SelK2 | I.V., single-dose |
| BIOLOGICAL | Enoxaparin | SC, QD for up to 10 ± 2 days |
Timeline
- Start date
- 2019-02-20
- Primary completion
- 2019-10-01
- Completion
- 2019-11-14
- First posted
- 2019-01-23
- Last updated
- 2021-01-06
- Results posted
- 2020-11-24
Locations
21 sites across 5 countries: Bulgaria, Latvia, Lithuania, Poland, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03812328. Inclusion in this directory is not an endorsement.