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

PHASE2CompletedINTERVENTIONAL
Enrollment

308

Participants

Timeline

Start Date

November 13, 2017

Primary Completion Date

November 5, 2018

Study Completion Date

November 5, 2018

Conditions
VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery
Interventions
DRUG

JNJ-64179375 0.3 mg/kg

JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion as a single dose on Day 1.

DRUG

JNJ-64179375 0.6 mg/kg

JNJ-64179375 0.6 mg/kg IV infusion as a single dose on Day 1.

DRUG

JNJ-64179375 1.2 mg/kg

JNJ-64179375 1.2 mg/kg IV infusion as a single dose on Day 1.

DRUG

JNJ-64179375 (Dose to be Determined)

JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1.

DRUG

JNJ-64179375 A mg/kg

JNJ-64179375 Dose A mg/kg IV as a single dose on Day 1.

DRUG

JNJ-64179375 B mg/kg

JNJ-64179375 Dose B mg/kg IV as a single dose on Day 1.

DRUG

JNJ-64179375 C mg/kg

JNJ-64179375 Dose C mg/kg IV as a single dose on Day 1.

DRUG

JNJ-64179375 D mg/kg

JNJ-64179375 Dose D mg/kg IV as a single dose on Day 1.

DRUG

Placebo JNJ-64179375

Matching JNJ-64179375 placebo (normal saline) administered as IV infusion as a single dose on Day 1.

DRUG

Apixaban placebo

Matching apixaban placebo administered orally twice a day for 10 to 14 days.

DRUG

Apixaban 2.5 mg

Apixaban 2.5 mg administered orally twice a day for 10 to 14 days.

Trial Locations (103)

1407

Acibadem City Clinic Tokuda Hospital, Sofa

1606

Military Medical Academy, Sofia

2000

Sanatorio Britanico de Rosario, Rosario

2020

ZNA Middelheim, Antwerp

2170

ZNA Jan Palfijn, Merksem

3500

Jessa Ziekenhuis, Hasselt

3600

Ziekenhuis Oost-Limburg, Genk

5000

Hospital San Roque, Córdoba

7002

Multiprofile Hospital for Active Treatment Russe, Rousse

10126

A.O.U. Città della Salute e della Scienza, Torino

10128

Ospedale Mauriziano (Torino), Torino

15706

Hosp. Clinico Univ. de Santiago, Santiago de Compostela

18009

Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council, Cherkasy

20089

Istituto Clinico Humanitas, Rozzano

20097

IRCCS Policlinico San Donato, S. Donato Milanese

21018

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

24125

Cliniche Humanitas Gavazzeni, Bergamo

24127

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

25100

Hospital Tengku Ampuan Afzan, Kuantan

28040

Hosp. Clinico San Carlos, Madrid

Hosp. Univ. Fund. Jimenez Diaz, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. La Paz, Madrid

32504

Avanza research, Pensacola

32720

Florida Research Associates, LLC, DeLand

33321

University Orthopedic and Joint Replacement Center, Tamarac

34147

Bakirkoy Training and Research Hospital, Istanbul

34764

Umraniye Training and Research Hospital, Istanbul

35180

Izmir Tepecik Training and Research Hospital, Izmir

40136

Istituto Ortopedico Rizzoli, Bologna

46026

Hosp. Univ. I Politecni La Fe, Valencia

50134

Azienda Ospedaliera Universitaria Careggi, Florence

59100

University Malaya Medical Center, Kuala Lumpur

61024

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

61176

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

69600

Zaporizhzhia Regional Clinical Hospital, Zaporizhzhia

76008

Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk

77024

Memorial Hermann Memorial City Medical Center, Houston

79495

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

80113

Denver Metro Orthopedics, PC, Englewood

85053

Arizona Research Center, Phoenix

90509

Harbor-UCLA Medical Center, Torrance

92288

Klaipeda University Hospital, Klaipėda

96000

Hospital Sibu, Sibu

98000

Hospital Miri, Miri

117049

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

150003

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

194354

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

195427

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

443095

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

603155

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

640014

Russian Ilizarov Scientific Center For Restorative Traumatology And Ortopaedics, Kurgan

656045

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

C1199ABB

Hospital Italiano de Buenos Aires, Caba

C1430EGF

Clínica Adventista Belgrano, CABA

X5000EPU

Clínica Chutro, Córdoba

B1900AXI

Hospital Italiano La Plata, La Plata

B1663GFL

Sanatorio San Miguel, San Miguel

30130-100

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

30360-290

Hospital Sao Francisco de Assis, Belo Horizonte

13083-888

Unicamp - Hospital de Clinicas, Campinas

86050-000

Uniort.e - Hospital de ortopedia, Londrina

17515-000

Irmandade da Santa Casa de Misericórdia de Marília, Marília

90020-090

Santa Casa de Misericordia de Porto Alegre, Porto Alegre

09030-010

Hospital e Maternidade Dr Christovão da Gama, Santo André

09190-615

Hospital Estadual Mario covas, Santo André

05403-010

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

L1S 2J4

Lakeridge Health Ajax, Ajax

N2M 1A1

Source Trial Solutions Inc., Kitchener

K1H 8L6

The Ottawa Hospital Research Institute, Ottawa

270-2296

Matsudo City General Hospital, Chiba

040-8611

Hakodate Goryokaku Hospital, Hakodate

395-8505

Ritsuzankai Iida Hospital, Iida-shi

664-8540

Itami City Hospital, Itami-shi

890-0062

Yonemori Hospital, Kagoshima

969-6593

Bange Kousei General Hospital, Kawanuma-Gun

530-0012

Osaka Saiseikai Nakatsu Hospital, Osaka

591-8025

Osaka Rosai Hospital, Osaka

770-0812

Tokushima Municipal Hospital, Tokushima

901-0243

Yuaikai Tomishiro Central Hospital, Tomishiro

LV-3414

Regional Hospital of Liepaja, Liepāja

LV1004

Riga 2nd Hospital, Riga

LV1005

Hospital of Traumatology and Orthopedics, Riga

LV-4201

Vidzemes Hospital, Valmiera

LT50161

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

08000

Hospital Sultan Abdul Halim, Sungai Petani

15-276

Klinika Ortopedii i Traumatologii UMB, Bialystok

19-203

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

40-635

Klinika Ortopedii Gornoslaskie Centrum Medyczne, Katowice

31-826

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

33-332

SP ZOZ MSWiA w Krakowie Oddzial Urazowo-Ortopedyczny, Krakow

92-213

CSK UM Klinika Ortopedii, Lodz

20-718

Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny, Lublin

61-545

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

33-100

Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika, Tarnów

03-242

Oddzial Chirurgii Urazowej iOrtopedycznej,Wojewodzki Szpital Brodnowski, SPZOZ, Warsaw

08916

Hosp. Univ. Germans Trias I Pujol, Badalona

08208

Corporacio Sanitari Parc Tauli, Sabadell

06100

Ankara Numune Research and Training Hospital, Ankara

06110

Dışkapı Yıldırım Beyazıd Training and Research Hospital, Ankara

06370

Yıldırım Beyazıt University Yenimahalle Training and Research Hospital, Ankara

06800

Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital, Ankara

04107

Kyiv Regional Clinical Hospital, Kyiv

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03251482 - A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery | Biotech Hunter | Biotech Hunter