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

Tetherex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: SelK2; Biological: Enoxaparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03812328

2018-003122-88 (EudraCT Number)

SELK2-00005

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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207 participants in 3 patient groups

SelK2 and Enoxaparin

Experimental group

Description:

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

Treatment:

Biological: Enoxaparin

Drug: SelK2

Enoxaparin

Active Comparator group

Description:

SC, QD for up to 10 ± 2 days

Treatment:

Biological: Enoxaparin

SelK2

Experimental group

Description:

I.V., single-dose

Treatment:

Drug: SelK2