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

Venous Thromboembolism Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812328
• Other study ID #: SELK2-00005
• Secondary ID: 2018-003122-88
• Status: Completed
• Phase: Phase 2
• Start date: February 20, 2019
• Est. completion date: November 14, 2019

Study information

• Verified date: December 2020
• Source: Tetherex Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: November 14, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• SelK2
I.V., single-dose

Biological:
• Enoxaparin
SC, QD for up to 10 ± 2 days

Locations

Country	Name	City	State
Bulgaria	UMHAT Kanev AD	Ruse
Bulgaria	Acibadem City Clinic Tokuda Hospital EAD	Sofia
Bulgaria	UMHAT Tsaritsa Yoanna - ISUL	Sofia
Latvia	Regional Hospital of Liepaja	Liepaja
Latvia	Hospital of Traumatology and Orthopaedics	Riga
Latvia	ORTO Clinic	Riga
Latvia	Riga's 2nd Hospital	Riga
Latvia	Vidzemes Hospital	Valmiera
Lithuania	Kaunas Clinical Hospital	Kaunas
Lithuania	Klaipeda University Hospital	Klaipeda
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Bielsk Podlaski
Poland	Szpital Ogólny im. dr Witolda Ginela w Grajewie	Grajewo
Poland	Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie	Kraków
Poland	SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi	Lódz
Poland	Wojewódzki Szpital Specjalistyczny	Lublin
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego	Wroclaw
Ukraine	Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council	Cherkasy
Ukraine	Center of Traumatology & Orthopedics	Chernivtsi
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivs'k
Ukraine	Kiev Regional Clinical Hospital	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Tetherex Pharmaceuticals Corporation

Countries where clinical trial is conducted

Bulgaria,  Latvia,  Lithuania,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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