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

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Central Research Associates, Inc.

Birmingham, AL United States

Harbor-UCLA Medical Center

Torrance, CA United States

Denver Metro Orthopedics, PC

Englewood, CO United States

Florida Research Associates, LLC

DeLand, FL United States

Precision Clinical Research

Lauderdale Lakes, FL United States

Avanza research

Pensacola, FL United States

Tekton Research Inc.

Austin, TX United States

Cl nica Adventista Belgrano

Caba, Argentina

Hospital Italiano La Plata

La Plata, Argentina

Sanatorio Britanico de Rosario

Rosario, Argentina

Sanatorio San Miguel

San Miguel, Argentina

ZNA Middelheim

Antwerpen, Belgium

A.Z. Sint Jan

Brugge, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

ZNA Jan Palfijn

Merksem, Belgium

Hospital Sao Francisco de Assis

Belo Horizonte, Brazil

MHAT Tzaritza Joanna

Sofia, Bulgaria

Military Medical Academy

Sofia, Bulgaria

MHAT 'Sv. Anna - Varna' AD

Varna, Bulgaria

Lakeridge Health Ajax

Ajax, ON Canada

Source Trial Solutions Inc.

Kitchener, ON Canada

Lakeridge Health Oshawa

Oshawa, ON Canada

Fakultni nemocnice Brno

Brno, Czechia

Urazova nemocnice v Brne

Brno, Czechia

Nemocnice Jihlava

Jihlava, Czechia

Oblastn nemocnice Kladno

Kladno, Czechia

Nemocnice Bulovka

Praha, Czechia

Papageorgiou General Hospital

Thessaloniki, Greece

Policlinico S. Matteo

Pavia, Italy

IRCCS Policlinico San Donato

S. Donato Milanese ( Mi), Italy

Nihon University Hospital

Chiyoda, Japan

Fukuoka Rehabilitation Hospital

Fukuoka-Shi, Japan

KKR Hamanomachi Hospital

Fukuoka, Japan

Hakodate Goryokaku Hospital

Hakodate, Japan

Ritsuzankai Iida Hospital

Iida-Shi, Japan

Itami City Hospital

Itami-Shi, Japan

Yonemori Hospital

Kagoshima-Shi, Japan

Bange Kousei General Hospital

Kawanuma-Gun, Japan

Osaka Rosai Hospital

Osaka, Japan

Saitama City Hospital

Saitama, Japan

Takatsuki General Hospital

Takatsuki, Japan

Tokushima Municipal Hospital

Tokushima-Shi, Japan

Riga 2nd Hospital

Riga, Latvia

Orto Clinic Ltd

Riga, Latvia

Vidzemes Hospital

Valmiera, Latvia

Klaipeda University Hospital

Klaipeda, Lithuania

University Malaya Medical Center

Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia

Hospital Miri

Miri, Malaysia

Hospital Sibu

Sibu, Malaysia

Hospital Sultan Abdul Halim

Sungai Petani, Malaysia

Hospital Lus adas

Lisboa, Portugal

Spitalul Clinic Judetean Mures

Tg. Mures, Romania

Rostov State Medical University

Rostov On Don, Russian Federation

Clinical Emergency Hospital n.a. N.V. Solovyev

Yaroslavl, Russian Federation

Hosp. Clinico San Carlos

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp. Clinico Univ. de Santiago

Santiago De Compostela, Spain

Platte Valley Medical Group

Kearney, NE United States

Chiang Mai University

Chiang Mai, Thailand

Thammasat University Hospital

Pathumthani, Thailand

Arizona Research Center

Phoenix, AZ United States

Medicor Research Inc.

Sudbury, ON Canada

Nova Clinical Research, LLC

Bradenton, FL United States

Clinica Privada Velez Sarsfield

Cordoba, Argentina

City Hospital named after St. Martyr Elizabeth

Saint-Petersburg, Russian Federation

Hospital San Roque

Córdoba, Argentina

Cl nica Chutro

Córdoba, Argentina

Hospital Estadual Mario covas

Santo André, Brazil

Oblastn nemocnice Kol n

Kolín, Czechia

Hosp. Univ. de Canarias

San Cristóbal De La Laguna, Spain

Recruitment Status: Closed


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