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

Phase 2

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: SelK2; Biological: Enoxaparin

• Registration Number: NCT03812328
• Lead Sponsor: Tetherex Pharmaceuticals Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-23
• Study Start: 2019-02-20
• Primary Completion: 2019-10-01
• Study Completion: 2019-11-14
• Results First Submitted: 2020-10-30
• Results First Submitted QC: 2020-10-30
• Results First Posted: 2020-11-24
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Total Venous Thromboembolism	10 ± 2 Days After Total Knee Replacement	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	10 ± 2 Days After Total Knee Replacement	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.

Trial Locations

Locations (21)

UMHAT Kanev AD; 🇧🇬 Ruse, Bulgaria

Vidzemes Hospital; 🇱🇻 Valmiera, Latvia

Kaunas Clinical Hospital; 🇱🇹 Kaunas, Lithuania

Klaipeda University Hospital; 🇱🇹 Klaipeda, Lithuania

Samodzielny Publiczny Zakład Opieki Zdrowotnej; 🇵🇱 Bielsk Podlaski, Poland

Szpital Ogólny im. dr Witolda Ginela w Grajewie; 🇵🇱 Grajewo, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie; 🇵🇱 Kraków, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; 🇵🇱 Wrocław, Poland

Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council; 🇺🇦 Cherkasy, Ukraine

Ivano-Frankivsk Regional Clinical Hospital; 🇺🇦 Ivano-Frankivs'k, Ukraine

UMHAT Tsaritsa Yoanna - ISUL; 🇧🇬 Sofia, Bulgaria

Uniwersytecki Szpital Kliniczny w Białymstoku; 🇵🇱 Białystok, Poland

Hospital of Traumatology and Orthopaedics; 🇱🇻 Riga, Latvia

ORTO Clinic; 🇱🇻 Riga, Latvia

Riga's 2nd Hospital; 🇱🇻 Riga, Latvia

Wojewódzki Szpital Specjalistyczny; 🇵🇱 Lublin, Poland

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi; 🇵🇱 Łódź, Poland

Kiev Regional Clinical Hospital; 🇺🇦 Kiev, Ukraine

Acibadem City Clinic Tokuda Hospital EAD; 🇧🇬 Sofia, Bulgaria

Regional Hospital of Liepaja; 🇱🇻 Liepāja, Latvia

Center of Traumatology & Orthopedics; 🇺🇦 Chernivtsi, Ukraine