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

NCT03812328 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: SELK2-000052018-003122-88
• Study Type: interventional
• Target: 207
• Locations: 5 countries
• Sites: 21

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.

Conditions

Venous Thromboembolism

Keywords

venous thromboembolism; adhesion molecule; P-selectin glycoprotein ligand 1; P-selectin; venous thrombosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

SelK2 and Enoxaparin

EXPERIMENTAL

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

Drug: SelK2; Biological: Enoxaparin

Enoxaparin

ACTIVE COMPARATOR

SC, QD for up to 10 ± 2 days

Biological: Enoxaparin

SelK2

EXPERIMENTAL

I.V., single-dose

Drug: SelK2

Interventions

SelK2 DRUG

I.V., single-dose

SelK2; SelK2 and Enoxaparin

Enoxaparin BIOLOGICAL

SC, QD for up to 10 ± 2 days

Also known as: Lovenox

Enoxaparin; SelK2 and Enoxaparin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, 18-80 years of age (inclusive)
• Planned to undergo elective, primary total unilateral Total Knee Arthroplasty under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Tetherex Pharmaceuticals Corporation: lead

Study Sites (21)

UMHAT Kanev AD

Rousse, Bulgaria

Location

Acibadem City Clinic Tokuda Hospital EAD

Sofia, Bulgaria

Location

UMHAT Tsaritsa Yoanna - ISUL

Sofia, Bulgaria

Location

Regional Hospital of Liepaja

Liepāja, Latvia

Location

Hospital of Traumatology and Orthopaedics

Riga, Latvia

Location

ORTO Clinic

Riga, Latvia

Location

Riga's 2nd Hospital

Riga, Latvia

Location

Vidzemes Hospital

Valmiera, Latvia

Location

Kaunas Clinical Hospital

Kaunas, Lithuania

Location

Klaipeda University Hospital

Klaipėda, Lithuania

Location

Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, Poland

Location

Samodzielny Publiczny Zakład Opieki Zdrowotnej

Bielsk Podlaski, Poland

Location

Szpital Ogólny im. dr Witolda Ginela w Grajewie

Grajewo, Poland

Location

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Krakow, Poland

Location

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

Lodz, Poland

Location

Wojewódzki Szpital Specjalistyczny

Lublin, Poland

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

Wroclaw, Poland

Location

Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council

Cherkasy, Ukraine

Location

Center of Traumatology & Orthopedics

Chernivtsi, Ukraine

Location

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, Ukraine

Location

Kiev Regional Clinical Hospital

Kiev, Ukraine

Location

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Jonathan Stocker, Ph.D.
• Organization: Tetherex Pharmaceuticals

jstocker@tetherex.com

855-222-0722

Study Officials

• Russell Rother, Ph.D.

  Tetherex Pharmaceuticals Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: February 20, 2019
• Primary Completion: October 1, 2019
• Study Completion: November 14, 2019
• Last Updated: January 6, 2021
• Results First Posted: November 24, 2020

Record last verified: 2020-12

Locations

PL (7); BU (3); LA (5); LI (2); UA (4)