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

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SelK2
Enoxaparin
Sponsored by
Tetherex Pharmaceuticals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring venous thromboembolism, adhesion molecule, P-selectin glycoprotein ligand 1, P-selectin, venous thrombosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMHAT Kanev AD
  • Acibadem City Clinic Tokuda Hospital EAD
  • UMHAT Tsaritsa Yoanna - ISUL
  • Regional Hospital of Liepaja
  • Hospital of Traumatology and Orthopaedics
  • ORTO Clinic
  • Riga's 2nd Hospital
  • Vidzemes Hospital
  • Kaunas Clinical Hospital
  • Klaipeda University Hospital
  • Uniwersytecki Szpital Kliniczny w Białymstoku
  • Samodzielny Publiczny Zakład Opieki Zdrowotnej
  • Szpital Ogólny im. dr Witolda Ginela w Grajewie
  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
  • Wojewódzki Szpital Specjalistyczny
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
  • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
  • Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council
  • Center of Traumatology & Orthopedics
  • Ivano-Frankivsk Regional Clinical Hospital
  • Kiev Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

SelK2 and Enoxaparin

Enoxaparin

SelK2

Arm Description

I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)

SC, QD for up to 10 ± 2 days

I.V., single-dose

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2019
Last Updated
December 14, 2020
Sponsor
Tetherex Pharmaceuticals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03812328
Brief Title
Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement
Acronym
COURSE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
November 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tetherex Pharmaceuticals Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
venous thromboembolism, adhesion molecule, P-selectin glycoprotein ligand 1, P-selectin, venous thrombosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This was an adaptive design study. The first two arms of the study enrolled patients in a 1:1 ratio to receive either SelK2 or an active comparator. The adaptive arm (SelK2 plus active comparator) was initiated at the discretion of the Steering and Safety Committee. The study then enrolled patients in a 2:1 ratio to receive either SelK2 with an active comparator or an active comparator only.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SelK2 and Enoxaparin
Arm Type
Experimental
Arm Description
I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)
Arm Title
Enoxaparin
Arm Type
Active Comparator
Arm Description
SC, QD for up to 10 ± 2 days
Arm Title
SelK2
Arm Type
Experimental
Arm Description
I.V., single-dose
Intervention Type
Drug
Intervention Name(s)
SelK2
Intervention Description
I.V., single-dose
Intervention Type
Biological
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Lovenox
Intervention Description
SC, QD for up to 10 ± 2 days
Primary Outcome Measure Information:
Title
Percentage of Participants With Total Venous Thromboembolism
Description
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).
Time Frame
10 ± 2 Days After Total Knee Replacement
Title
Percentage of Participants With Major or Clinically Relevant Non-major Bleeding Events
Description
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.
Time Frame
10 ± 2 Days After Total Knee Replacement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Rother, Ph.D.
Organizational Affiliation
Tetherex Pharmaceuticals Corporation
Official's Role
Study Director
Facility Information:
Facility Name
UMHAT Kanev AD
City
Ruse
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda Hospital EAD
City
Sofia
Country
Bulgaria
Facility Name
UMHAT Tsaritsa Yoanna - ISUL
City
Sofia
Country
Bulgaria
Facility Name
Regional Hospital of Liepaja
City
Liepāja
Country
Latvia
Facility Name
Hospital of Traumatology and Orthopaedics
City
Riga
Country
Latvia
Facility Name
ORTO Clinic
City
Riga
Country
Latvia
Facility Name
Riga's 2nd Hospital
City
Riga
Country
Latvia
Facility Name
Vidzemes Hospital
City
Valmiera
Country
Latvia
Facility Name
Kaunas Clinical Hospital
City
Kaunas
Country
Lithuania
Facility Name
Klaipeda University Hospital
City
Klaipeda
Country
Lithuania
Facility Name
Uniwersytecki Szpital Kliniczny w Białymstoku
City
Białystok
Country
Poland
Facility Name
Samodzielny Publiczny Zakład Opieki Zdrowotnej
City
Bielsk Podlaski
Country
Poland
Facility Name
Szpital Ogólny im. dr Witolda Ginela w Grajewie
City
Grajewo
Country
Poland
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
City
Kraków
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny
City
Lublin
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
City
Wrocław
Country
Poland
Facility Name
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
City
Łódź
Country
Poland
Facility Name
Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council
City
Cherkasy
Country
Ukraine
Facility Name
Center of Traumatology & Orthopedics
City
Chernivtsi
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
Kiev Regional Clinical Hospital
City
Kiev
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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