Clinical trial NCT03812328: Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Keywords: venous thromboembolism
adhesion molecule
P-selectin glycoprotein ligand 1
P-selectin
venous thrombosis
Lead sponsor: Tetherex Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Percentage of Participants With Total Venous Thromboembolism
timeFrame: 10 ± 2 Days After Total Knee Replacement
measure: Percentage of Participants With Major or Clinically Relevant Non-major Bleeding Events
timeFrame: 10 ± 2 Days After Total Knee Replacement
Secondary outcomes:
Other outcomes:
Locations:
city: Ruse
country: Bulgaria
facility: UMHAT Kanev AD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital EAD
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Yoanna - ISUL
city: Liepāja
country: Latvia
facility: Regional Hospital of Liepaja
city: Riga
country: Latvia
facility: Hospital of Traumatology and Orthopaedics
city: Riga
country: Latvia
facility: ORTO Clinic
city: Riga
country: Latvia
facility: Riga's 2nd Hospital
city: Valmiera
country: Latvia
facility: Vidzemes Hospital
city: Kaunas
country: Lithuania
facility: Kaunas Clinical Hospital
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Białymstoku
city: Bielsk Podlaski
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej
city: Grajewo
country: Poland
facility: Szpital Ogólny im. dr Witolda Ginela w Grajewie
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
city: Lublin
country: Poland
facility: Wojewódzki Szpital Specjalistyczny
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
city: Łódź
country: Poland
facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
city: Cherkasy
country: Ukraine
facility: Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council
city: Chernivtsi
country: Ukraine
facility: Center of Traumatology & Orthopedics
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
city: Kiev
country: Ukraine
facility: Kiev Regional Clinical Hospital
Study officials:
affiliation: Tetherex Pharmaceuticals Corporation
name: Russell Rother, Ph.D.
role: STUDY_DIRECTOR
References: