Last updated on December 2018

A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery


Brief description of study

The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).

Detailed Study Description

This study has 2 parts, dose escalation and dose-response evaluation, and will be conducted in participants undergoing primary unilateral elective Total Knee Replacement (TKR) surgery. Participants will participate in either Part 1 or Part 2 of study only. The study will be conducted in 3 phases: an up to 30-day screening phase before surgery, a 14-day double-blind dosing phase, and a 16-week follow-up phase. Safety evaluations will include monitoring of all nonserious and serious adverse events, clinical laboratory tests, vital signs measurements, and physical examinations. Pharmacokinetics (dense and sparse), pharmacodynamic (PD), health resource utilization, and immunogenicity samples will also be assessed. The total study duration of participant's participation in Part 1 or part 2 after randomization will be approximately 18 weeks.

Clinical Study Identifier: NCT03251482

Contact Investigators or Research Sites near you

Start Over

Study Contact

Central Research Associates, Inc.
Birmingham, AL United States

Study Contact

Harbor-UCLA Medical Center
Torrance, CA United States

Study Contact

Denver Metro Orthopedics, PC
Englewood, CO United States

Study Contact

Florida Research Associates, LLC
DeLand, FL United States

Study Contact

Precision Clinical Research
Lauderdale Lakes, FL United States

Study Contact

Avanza research
Pensacola, FL United States

Study Contact

University Orthopedic and Joint Replacement Center
Tamarac, FL United States

Study Contact

Tekton Research Inc.
Austin, TX United States

Study Contact

Memorial Hermann Memorial City Medical Center
Houston, TX United States

Study Contact

Hospital Italiano de Buenos Aires
Caba, Argentina

Study Contact

Cl nica Adventista Belgrano
Caba, Argentina

Study Contact

Hospital Italiano La Plata
La Plata, Argentina

Study Contact

Sanatorio Britanico de Rosario
Rosario, Argentina

Study Contact

Sanatorio San Miguel
San Miguel, Argentina

Study Contact

ZNA Middelheim
Antwerpen, Belgium

Study Contact

A.Z. Sint Jan
Brugge, Belgium

Study Contact

Ziekenhuis Oost-Limburg
Genk, Belgium

Study Contact

Jessa Ziekenhuis
Hasselt, Belgium

Study Contact

ZNA Jan Palfijn
Merksem, Belgium

Study Contact

Universidade Federal de Minas Gerais (UFMG) - Faculdade de Medicina
Belo Horizonte, Brazil

Study Contact

Hospital Sao Francisco de Assis
Belo Horizonte, Brazil

Study Contact

Unicamp - Hospital de Clinicas
Campinas, Brazil

Study Contact

Hospital De Cl nicas Da Universidade Federal Do Paran
Curitiba, Brazil

Study Contact

Uniort.e - Hospital de ortopedia
Londrina, Brazil

Study Contact

Irmandade da Santa Casa de Miseric rdia de Mar lia
Marilia, Brazil

Study Contact

Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil

Study Contact

Multiprofile Hospital for Active Treatment Russe
Russe, Bulgaria

Study Contact

Acibadem City Clinic Tokuda Hospital
Sofa, Bulgaria

Study Contact

MHAT Tzaritza Joanna
Sofia, Bulgaria

Study Contact

Military Medical Academy
Sofia, Bulgaria

Study Contact

Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD
Varna, Bulgaria

Study Contact

MHAT 'Sv. Anna - Varna' AD
Varna, Bulgaria

Study Contact

Lakeridge Health Ajax
Ajax, ON Canada

Study Contact

Hamilton Health Sciences - Juravinski site
Hamilton, ON Canada

Study Contact

Source Trial Solutions Inc.
Kitchener, ON Canada

Study Contact

Lakeridge Health Oshawa
Oshawa, ON Canada

Study Contact

The Ottawa Hospital Research Institute
Ottawa, ON Canada

Study Contact

Fakultni nemocnice Brno
Brno, Czechia

Study Contact

Urazova nemocnice v Brne
Brno, Czechia

Study Contact

Nemocnice Jihlava
Jihlava, Czechia

Study Contact

Oblastn nemocnice Kladno
Kladno, Czechia

Study Contact

Nemocnice Bulovka
Praha, Czechia

Study Contact

General Hospital of Nea Ionia 'Konstantopoulio'
Nea Ionia, Greece

Study Contact

University General Hospital of Rio Patras
Patra, Greece

Study Contact

Papageorgiou General Hospital
Thessaloniki, Greece

Study Contact

Cliniche Humanitas Gavazzeni
Bergamo, Italy

Study Contact

Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy

Study Contact

Istituto Ortopedico Rizzoli
Bologna, Italy

Study Contact

Azienda Ospedaliera Universitaria Careggi
Firenze, Italy

Study Contact

Policlinico S. Matteo
Pavia, Italy

Study Contact

Istituto Clinico Humanitas
Rozzano, Italy

Study Contact

IRCCS Policlinico San Donato
S. Donato Milanese ( Mi), Italy

Study Contact

A.O.U. Citt della Salute e della Scienza
Torino, Italy

Study Contact

Ospedale Mauriziano (Torino)
Torino, Italy

Study Contact

Nihon University Hospital
Chiyoda, Japan

Study Contact

Fukuoka Rehabilitation Hospital
Fukuoka-Shi, Japan

Study Contact

KKR Hamanomachi Hospital
Fukuoka, Japan

Study Contact

Hakodate Goryokaku Hospital
Hakodate, Japan

Study Contact

Kansai Medical University Hospital
Hirakata, Japan

Study Contact

Ritsuzankai Iida Hospital
Iida-Shi, Japan

Study Contact

Itami City Hospital
Itami-Shi, Japan

Study Contact

Yonemori Hospital
Kagoshima-Shi, Japan

Study Contact

Bange Kousei General Hospital
Kawanuma-Gun, Japan

Study Contact

Kurume University Medical Center
Kurume, Japan

Study Contact

NHO Okayama Medical Center
Okayama, Japan

Study Contact

Osaka Saiseikai Nakatsu Hospital
Osaka-Shi, Japan

Study Contact

Osaka Rosai Hospital
Osaka, Japan

Study Contact

Saitama City Hospital
Saitama, Japan

Study Contact

Takatsuki General Hospital
Takatsuki, Japan

Study Contact

Tokushima Municipal Hospital
Tokushima-Shi, Japan

Study Contact

National Center for Global Health and Medicine
Tokyo, Japan

Study Contact

Yuaikai Tomishiro Central Hospital
Tomishiro, Japan

Study Contact

Saiseikai Yokohamashi Tobu Hospital
Yokohama-Shi, Japan

Study Contact

Yokohama City University Medical Center
Yokohama, Japan

Study Contact

Regional Hospital of Liepaja
Liepaja, Latvia

Study Contact

Riga 2nd Hospital
Riga, Latvia

Study Contact

Hospital of Traumatology and Orthopedics
Riga, Latvia

Study Contact

Orto Clinic Ltd
Riga, Latvia

Study Contact

Riga East Clinical University Hospital
Riga, Latvia

Study Contact

Vidzemes Hospital
Valmiera, Latvia

Study Contact

Kaunas Clinical Hospital, Public Institution
Kaunas, Lithuania

Study Contact

Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania

Study Contact

Klaipeda University Hospital
Klaipeda, Lithuania

Study Contact

Republican Vilnius University Hospital, Public Institution
Vilnius, Lithuania

Study Contact

University Malaya Medical Center
Kuala Lumpur, Malaysia

Study Contact

Hospital Tengku Ampuan Afzan
Kuantan, Malaysia

Study Contact

Hospital Miri
Miri, Malaysia

Study Contact

Hospital Sibu
Sibu, Malaysia

Study Contact

Hospital Sultan Abdul Halim
Sungai Petani, Malaysia

Study Contact

Klinika Ortopedii i Traumatologii UMB
Bialystok, Poland

Study Contact

Oddzial Ortopedii i Traumatologii - Szpital Ogolny im. W.Ginela
Grajewo, Poland

Study Contact

Klinika Ortopedii Gornoslaskie Centrum Medyczne
Katowice, Poland

Study Contact

Oddzial Ortopedii i Traumatologii Szpital Specjalistyczny im. L.Rydygiera
Krakow, Poland

Study Contact

SP ZOZ MSWiA w Krakowie Oddzial Urazowo-Ortopedyczny
Krakow, Poland

Study Contact

CSK UM Klinika Ortopedii
Lodz, Poland

Study Contact

Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny
Lublin, Poland

Study Contact

Klinika Ortopedii I Traumatologii,Szpital Kliniczny Ortopedyczno-Rehabilitacyjny UM
Poznan, Poland

Study Contact

Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika
Tarnow, Poland

Study Contact

Oddzial Chirurgii Urazowej iOrtopedycznej,Wojewodzki Szpital Brodnowski, SPZOZ
Warszawa, Poland

Study Contact

Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro
Aveiro, Portugal

Study Contact

Centro Cl nico Acad mico - Braga, Associa o (2CA-Braga)
Braga, Portugal

Study Contact

Centro Hospitalar Lisboa Ocidental - Hospital S o Fracisco Xavier
Lisboa, Portugal

Study Contact

Hospital Lus adas
Lisboa, Portugal

Study Contact

Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria
Lisboa, Portugal

Study Contact

Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
Bucuresti, Romania

Study Contact

Spitalul Clinic de Urgenta Sfantul Pantelimon
Bucuresti, Romania

Study Contact

Spitalul Clinic de Urgenta Sfantul Ioan
Bucuresti, Romania

Study Contact

Spitalul Universitar de Urgenta Bucuresti
Bucuresti, Romania

Study Contact

Spitalul Clinic Judetean de Urgenta
Cluj-Napoca, Romania

Study Contact

Spitalul Clinic Judetean de Urgenta 'Sfantul Spiridon'
Iasi, Romania

Study Contact

Spitalul Clinic Judetean Mures
Tg. Mures, Romania

Study Contact

Spitalul Clinic Judetean de Urgenta 'Pius Branzeu'
Timisoara, Romania

Study Contact

Barnaul Federal Center of Traumatology, Orthopedics and Endoprothesis replacement
Barnaul, Russian Federation

Study Contact

Russian Ilizarov Scientific Center For Restorative Traumatology And Ortopaedics
Kurgan, Russian Federation

Study Contact

Moscow City Clinical Hospital #1 n.a. N.I.Pirogov
Moscow, Russian Federation

Study Contact

Novosibirsk Research Institute of Traumatology and Orthopedics n.a. Ya.L.Tsyv'yan
Novosibirsk, Russian Federation

Study Contact

Rostov State Medical University
Rostov On Don, Russian Federation

Study Contact

St. Petersburg State Medical Institution City Multifunctional Hospital #2
Saint-Petersburg, Russian Federation

Study Contact

Russian Research Institute of Traumatology and Orthopaedics n.a.R.R.Vreden
Saint-Petersburg, Russian Federation

Study Contact

State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin
Samara, Russian Federation

Study Contact

Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, Russian Federation

Study Contact

Hosp. Univ. Germans Trias I Pujol
Badalona, Spain

Study Contact

Hosp. Clinico San Carlos
Madrid, Spain

Study Contact

Hosp. Univ. Fund. Jimenez Diaz
Madrid, Spain

Study Contact

Hosp. Univ. 12 de Octubre
Madrid, Spain

Study Contact

Hosp. Univ. La Paz
Madrid, Spain

Study Contact

Corporacio Sanitari Parc Tauli
Sabadell, Spain

Study Contact

Hosp. Clinico Univ. de Santiago
Santiago De Compostela, Spain

Study Contact

Hosp. Univ. I Politecni La Fe
Valencia, Spain

Study Contact

Ankara Numune Research and Training Hospital
Ankara, Turkey

Study Contact

D kap Y ld r m Beyaz d Training and Research Hospital
Ankara, Turkey

Study Contact

Y ld r m Beyaz t University Yenimahalle Training and Research Hospital
Ankara, Turkey

Study Contact

Yildirim Beyazit University Medical Faculty Ankara Atat rk Research and Training Hospital
Ankara, Turkey

Study Contact

Medipol Mega University Hospital
Istanbul, Turkey

Study Contact

On Dokuz May s University Medical Faculty
Samsun, Turkey

Study Contact

Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, Ukraine

Study Contact

Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, Ukraine

Study Contact

Institute of Spine and JointPathology named after Prof.Sytenko of NationalAcademy of MedicalSciences
Kharkiv, Ukraine

Study Contact

Municipal Institution of Health Care 'Kharkiv Regional Clinical Traumatology Hospital'
Kharkiv, Ukraine

Study Contact

Kyiv City Clinical Emergency Care Hospital
Kyiv, Ukraine

Study Contact

Kyiv Regional Clinical Hospital
Kyiv, Ukraine

Study Contact

Communal Institution of Lviv Regional Council 'Lypa Lviv Regional Hospital'
Lviv-Vynnyky, Ukraine

Study Contact

Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
Vinnytsia, Ukraine

Study Contact

Zaporizhzhia Regional Clinical Hospital
Zaporizhzhia, Ukraine

Study Contact

Platte Valley Medical Group
Kearney, NE United States

Study Contact

University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
Pleven, Bulgaria

Study Contact

Matsudo City General Hospital
Chiba, Japan

Study Contact

Phramongkutklao Hospital and Medical College
Bangkok, Thailand

Study Contact

King Chulalongkorn Memorial Hospital
Bangkok, Thailand

Study Contact

Chiang Mai University
Chiang Mai, Thailand

Study Contact

Thammasat University Hospital
Pathumthani, Thailand

Study Contact

Arizona Research Center
Phoenix, AZ United States

Study Contact

Medicor Research Inc.
Sudbury, ON Canada

Study Contact

Nova Clinical Research, LLC
Bradenton, FL United States

Study Contact

Clinica Privada Velez Sarsfield
Cordoba, Argentina

Study Contact

General Hospital of Attiki 'KAT'
Kifisia, Greece

Study Contact

Privolzhsky Research Medical University of Ministry of Health of Russian Federation
Nizhny Novgorod, Russian Federation

Study Contact

City Hospital named after St. Martyr Elizabeth
Saint-Petersburg, Russian Federation

Study Contact

Bakirkoy Training and Research Hospital
Istanbul, Turkey

Study Contact

Umraniye Training and Research Hospital
Istanbul, Turkey

Study Contact

Dokuz Eyl l University Medical Faculty
Izmir, Turkey

Study Contact

Izmir Tepecik Training and Research Hospital
Izmir, Turkey

Study Contact

HUC - Hospital Universit rio Cajuru
Curitiba, Brazil

Study Contact

Hospital San Roque
Córdoba, Argentina

Study Contact

Cl nica Chutro
Córdoba, Argentina

Study Contact

Hospital e Maternidade Dr Christov o da Gama
Santo André, Brazil

Study Contact

Hospital Estadual Mario covas
Santo André, Brazil

Study Contact

Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo
São Paulo, Brazil

Study Contact

Oblastn nemocnice Kol n
Kolín, Czechia

Study Contact

Hyogo College of Medicine Hospital
Nishinomiya, Japan

Study Contact

Katedra Ortopedii i Traumatologii Narzadu Ruchu UM im. Piastow Slaskich we Wroclawiu
Wroclaw, Poland

Study Contact

Hosp. Univ. Fundacion Alcorcon
Alcorcón, Spain

Study Contact

Hosp. Univ. de Canarias
San Cristóbal De La Laguna, Spain

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.