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

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Drug: SelK2; Biological: Enoxaparin

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Ruse, Bulgaria
    • UMHAT Kanev AD
  • Sofia, Bulgaria
    • Acibadem City Clinic Tokuda Hospital Ead
  • Sofia, Bulgaria
    • UMHAT Tsaritsa Yoanna - ISUL
• Latvia
  • Liepāja, Latvia
    • Regional Hospital of Liepaja
  • Riga, Latvia
    • Hospital of Traumatology and Orthopaedics
  • Riga, Latvia
    • Orto Clinic
  • Riga, Latvia
    • Riga's 2nd Hospital
  • Valmiera, Latvia
    • Vidzemes Hospital
• Lithuania
  • Kaunas, Lithuania
    • Kaunas Clinical Hospital
  • Klaipeda, Lithuania
    • Klaipeda university hospital
• Poland
  • Białystok, Poland
    • Uniwersytecki Szpital Kliniczny w Białymstoku
  • Bielsk Podlaski, Poland
    • Samodzielny Publiczny Zakład Opieki Zdrowotnej
  • Grajewo, Poland
    • Szpital Ogólny im. dr Witolda Ginela w Grajewie
  • Kraków, Poland
    • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
  • Lublin, Poland
    • Wojewodzki Szpital Specjalistyczny
  • Wrocław, Poland
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
  • Łódź, Poland
    • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
• Ukraine
  • Cherkasy, Ukraine
    • Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council
  • Chernivtsi, Ukraine
    • Center of Traumatology & Orthopedics
  • Ivano-Frankivs'k, Ukraine
    • Ivano-Frankivsk Regional Clinical Hospital
  • Kiev, Ukraine
    • Kiev Regional Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SelK2 and Enoxaparin; I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)	Drug: SelK2; I.V., single-dose; Biological: Enoxaparin; SC, QD for up to 10 ± 2 days; Other Names: Lovenox
Active Comparator: Enoxaparin; SC, QD for up to 10 ± 2 days	Biological: Enoxaparin; SC, QD for up to 10 ± 2 days; Other Names: Lovenox
Experimental: SelK2; I.V., single-dose	Drug: SelK2; I.V., single-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Total Venous Thromboembolism	The primary efficacy endpoint was incidence of total VTE (reported as a percentage of patients) during the Treatment Phase up to venography day (10 ± 2 days after total knee replacement). All efficacy endpoint data was adjudicated by the blinded Central Independent Adjudication Committee (CIAC).	10 ± 2 Days After Total Knee Replacement
Percentage of Participants With Major or Clinically Relevant Non-major Bleeding Events	All suspected bleeding events were reviewed by the Central Independent Adjudication Committee (CIAC) in a blinded fashion and were adjudicated for categorization as Major Bleeding (MB), Clinically Relevant Non-Major Bleeding (CRNMB), Minor Bleeding, or combination of MB and CRNMB. The outcome measure assessed the incidence of MB or CRNMB.	10 ± 2 Days After Total Knee Replacement

Collaborators and Investigators

• Sponsor: Tetherex Pharmaceuticals Corporation
• Investigators: Study Director: Russell Rother, Ph.D., Tetherex Pharmaceuticals Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): November 14, 2019

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: P-selectin; venous thrombosis; venous thromboembolism; adhesion molecule; P-selectin glycoprotein ligand 1
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin
• Other Study ID Numbers: SELK2-00005; 2018-003122-88 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes