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Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement

NCT03812328 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2021-01-06

Study results available
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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

  • Venous Thromboembolism

Interventions

DRUG

SelK2

I.V., single-dose

BIOLOGICAL

Enoxaparin

SC, QD for up to 10 ± 2 days

Sponsors & Collaborators

  • Tetherex Pharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Russell Rother, Ph.D. · Tetherex Pharmaceuticals Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2019-10-01
Completion
2019-11-14
FDA Drug
Yes

Countries

  • Bulgaria
  • Latvia
  • Lithuania
  • Poland
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812328 on ClinicalTrials.gov