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

November 5, 2019 updated by: Janssen Research & Development, LLC

A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design, Dose Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
308

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • Caba, Argentina, C1430EGF
        • Clinica Adventista Belgrano
      • Córdoba, Argentina, 5000
        • Hospital San Roque
      • Córdoba, Argentina, X5000EPU
        • Clínica Chutro
      • La Plata, Argentina, B1900AXI
        • Hospital Italiano La Plata
      • Rosario, Argentina, 2000
        • Sanatorio Británico de Rosario
      • San Miguel, Argentina, B1663GFL
        • Sanatorio San Miguel
  • Belgium
      • Antwerpen, Belgium, 2020
        • ZNA Middelheim
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg
      • Hasselt, Belgium, 3500
        • Jessa ziekenhuis
      • Merksem, Belgium, 2170
        • ZNA Jan Palfijn
  • Brazil
      • Belo Horizonte, Brazil, 30130-100
        • Universidade Federal de Minas Gerais (UFMG) - Faculdade de Medicina
      • Belo Horizonte, Brazil, 30360-290
        • Hospital Sao Francisco de Assis
      • Campinas, Brazil, 13083-888
        • Unicamp - Hospital de Clinicas
      • Londrina, Brazil, 86050-000
        • Uniort.e - Hospital de ortopedia
      • Marilia, Brazil, 17515-000
        • Irmandade da Santa Casa de Misericórdia de Marília
      • Porto Alegre, Brazil, 90020-090
        • Santa Casa de Misericordia de Porto Alegre
      • Santo André, Brazil, 09030-010
        • Hospital e Maternidade Dr Christóvão da Gama
      • Santo André, Brazil, 09190-615
        • Hospital Estadual Mario Covas
      • São Paulo, Brazil, 05403-010
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
  • Bulgaria
      • Russe, Bulgaria, 7002
        • Multiprofile Hospital for Active Treatment Russe
      • Sofa, Bulgaria, 1407
        • Acibadem City Clinic Tokuda Hospital
      • Sofia, Bulgaria, 1606
        • Military Medical Academy
  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J4
        • Lakeridge Health Ajax
      • Kitchener, Ontario, Canada, N2M 1A1
        • Source Trial Solutions Inc.
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Research Institute
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Bergamo, Italy, 24125
        • Cliniche Humanitas Gavazzeni
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
      • S. Donato Milanese, Italy, 20097
        • IRCCS Policlinico San Donato
      • Torino, Italy, 10126
        • A.O.U. Città della Salute e della Scienza
      • Torino, Italy, 10128
        • Ospedale Mauriziano (Torino)
  • Japan
      • Chiba, Japan, 270-2296
        • Matsudo City General Hospital
      • Hakodate, Japan, 040-8611
        • Hakodate Goryokaku Hospital
      • Iida-shi, Japan, 395-8505
        • Ritsuzankai Iida Hospital
      • Itami-shi, Japan, 664-8540
        • Itami City Hospital
      • Kagoshima-shi, Japan, 890-0062
        • Yonemori Hospital
      • Kawanuma-Gun, Japan, 969-6593
        • Bange Kousei General Hospital
      • Osaka, Japan, 591-8025
        • Osaka Rosai Hospital
      • Osaka-shi, Japan, 530-0012
        • Osaka Saiseikai Nakatsu Hospital
      • Tokushima-shi, Japan, 770-0812
        • Tokushima Municipal Hospital
      • Tomishiro, Japan, 901-0243
        • Yuaikai Tomishiro Central Hospital
  • Latvia
      • Liepaja, Latvia, LV-3414
        • Regional Hospital of Liepaja
      • Riga, Latvia, LV1004
        • Riga 2nd Hospital
      • Riga, Latvia, LV1005
        • Hospital of Traumatology and Orthopedics
      • Valmiera, Latvia, LV-4201
        • Vidzemes Hospital
  • Lithuania
      • Kaunas, Lithuania, LT50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
      • Klaipeda, Lithuania, 92288
        • Klaipeda university hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Center
      • Kuantan, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan
      • Miri, Malaysia, 98000
        • Hospital Miri
      • Sibu, Malaysia, 96000
        • Hospital Sibu
      • Sungai Petani, Malaysia, 08000
        • Hospital Sultan Abdul Halim
  • Poland
      • Bialystok, Poland, 15-276
        • Klinika Ortopedii i Traumatologii UMB
      • Grajewo, Poland, 19-203
        • Oddzial Ortopedii i Traumatologii - Szpital Ogolny im. W.Ginela
      • Katowice, Poland, 40-635
        • Klinika Ortopedii Gornoslaskie Centrum Medyczne
      • Krakow, Poland, 31-826
        • Oddzial Ortopedii i Traumatologii Szpital Specjalistyczny im. L.Rydygiera
      • Krakow, Poland, 33-332
        • SP ZOZ MSWiA w Krakowie Oddzial Urazowo-Ortopedyczny
      • Lodz, Poland, 92-213
        • CSK UM Klinika Ortopedii
      • Lublin, Poland, 20-718
        • Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny
      • Poznan, Poland, 61-545
        • Klinika Ortopedii I Traumatologii,Szpital Kliniczny Ortopedyczno-Rehabilitacyjny UM
      • Tarnow, Poland, 33-100
        • Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika
      • Warszawa, Poland, 03-242
        • Oddzial Chirurgii Urazowej iOrtopedycznej,Wojewodzki Szpital Brodnowski, SPZOZ
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • Barnaul Federal Center of Traumatology, Orthopedics and Endoprothesis replacement
      • Kurgan, Russian Federation, 640014
        • Russian Ilizarov Scientific Center For Restorative Traumatology And Ortopaedics
      • Moscow, Russian Federation, 117049
        • Moscow City Clinical Hospital #1 n.a. N.I.Pirogov
      • Nizhny Novgorod, Russian Federation, 603155
        • Privolzhsky Research Medical University of Ministry of Health of Russian Federation
      • Saint-Petersburg, Russian Federation, 194354
        • St. Petersburg State Medical Institution City Multifunctional Hospital #2
      • Saint-Petersburg, Russian Federation, 195427
        • Russian Research Institute of Traumatology and Orthopaedics n.a.R.R.Vreden
      • Samara, Russian Federation, 443095
        • State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin
      • Yaroslavl, Russian Federation, 150003
        • Clinical Emergency Hospital n.a. N.V. Solovyev
  • Spain
      • Badalona, Spain, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Madrid, Spain, 28040
        • Hosp. Clinico San Carlos
      • Madrid, Spain, 28040
        • Hosp. Univ. Fund. Jimenez Diaz
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28046
        • Hosp. Univ. La Paz
      • Sabadell, Spain, 08208
        • Corporacio Sanitari Parc Tauli
      • Santiago de Compostela, Spain, 15706
        • Hosp. Clinico Univ. de Santiago
      • Valencia, Spain, 46026
        • Hosp. Univ. I Politecni La Fe
  • Turkey
      • Ankara, Turkey, 06100
        • Ankara Numune Research and Training Hospital
      • Ankara, Turkey, 06110
        • Dışkapı Yıldırım Beyazıd Training and Research Hospital
      • Ankara, Turkey, 06370
        • Yıldırım Beyazıt University Yenimahalle Training and Research Hospital
      • Ankara, Turkey, 06800
        • Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital
      • Istanbul, Turkey, 34764
        • Ümraniye Training and Research Hospital
      • Istanbul, Turkey, 34147
        • Bakirkoy Training and Research Hospital
      • Izmir, Turkey, 35180
        • Izmir Tepecik Training and Research Hospital
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council
      • Ivano-Frankivsk, Ukraine, 76008
        • Ivano-Frankivsk Regional Clinical Hospital
      • Kharkiv, Ukraine, 61024
        • Institute of Spine and JointPathology named after Prof.Sytenko of NationalAcademy of MedicalSciences
      • Kharkiv, Ukraine, 61176
        • Municipal Institution of Health Care 'Kharkiv Regional Clinical Traumatology Hospital'
      • Kyiv, Ukraine, 04107
        • Kyiv Regional Clinical Hospital
      • Lviv-Vynnyky, Ukraine, 79495
        • Communal Institution of Lviv Regional Council 'Lypa Lviv Regional Hospital'
      • Vinnytsia, Ukraine, 21018
        • Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
      • Zaporizhzhia, Ukraine, 69600
        • Zaporizhzhia Regional Clinical Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
    • California
      • Torrance, California, United States, 90509
        • Harbor-UCLA Medical Center
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Denver Metro Orthopedics, PC
    • Florida
      • DeLand, Florida, United States, 32720
        • Florida Research Associates, LLC
      • Pensacola, Florida, United States, 32504
        • Avanza research
      • Tamarac, Florida, United States, 33321
        • University Orthopedic and Joint Replacement Center
    • Texas
      • Houston, Texas, United States, 77024
        • Memorial Hermann Memorial City Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Weight greater than or equal to (>=) 40 kg to less than or equal to (<=) 150 kilogram (kg)
  • Medically appropriate for postoperative anticoagulant prophylaxis as determined by the investigator
  • Has undergone an elective primary unilateral total knee replacement (TKR)
  • Before randomization, a woman must not be of childbearing potential defined as postmenopausal (defined as no menses for 12 months without an alternative medical cause) and/ or permanently sterile (include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy)
  • Contraceptive use by men should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies

Exclusion Criteria:

  • Any condition for which the use of apixaban is not recommended in the opinion of the investigator
  • Bilateral, revision or unicompartmental procedure
  • Known or suspected hypersensitivity or intolerance to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or any of the excipients of JNJ-64179375
  • Unable to undergo venography
  • Known previous deep vein thrombosis (DVT) in either lower extremity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)
Participants will receive JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenously (IV) or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
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: 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.
Experimental: Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)
Participants will receive JNJ-64179375 0.6 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
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.
Drug: JNJ-64179375 0.6 mg/kg
JNJ-64179375 0.6 mg/kg IV infusion as a single dose on Day 1.
Experimental: Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)
Participants will receive JNJ-64179375 1.2 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
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.
Drug: JNJ-64179375 1.2 mg/kg
JNJ-64179375 1.2 mg/kg IV infusion as a single dose on Day 1.
Experimental: Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)
Participants will receive JNJ-64179375 Dose to be determined (TBD) based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
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.
Drug: JNJ-64179375 (Dose to be Determined)
JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1.
Experimental: Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)
Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
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.
Drug: JNJ-64179375 (Dose to be Determined)
JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1.
Experimental: Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)
Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
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.
Drug: JNJ-64179375 (Dose to be Determined)
JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1.
Experimental: Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo
Participants will receive JNJ-64179375 Dose A mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
Drug: Apixaban placebo
Matching apixaban placebo administered orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 A mg/kg
JNJ-64179375 Dose A mg/kg IV as a single dose on Day 1.
Experimental: Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo
Participants will receive JNJ-64179375 Dose B mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
Drug: Apixaban placebo
Matching apixaban placebo administered orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 B mg/kg
JNJ-64179375 Dose B mg/kg IV as a single dose on Day 1.
Experimental: Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo
Participants will receive JNJ-64179375 Dose C mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
Drug: Apixaban placebo
Matching apixaban placebo administered orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 C mg/kg
JNJ-64179375 Dose C mg/kg IV as a single dose on Day 1.
Experimental: Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo
Participants will receive JNJ-64179375 Dose D mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
Drug: Apixaban placebo
Matching apixaban placebo administered orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 D mg/kg
JNJ-64179375 Dose D mg/kg IV as a single dose on Day 1.
Experimental: Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg
Participants will receive JNJ-64179375 placebo (saline) IV as a single dose on Day 1 and apixaban 2.5 mg orally twice a day for 10 to 14 days.
Drug: Placebo JNJ-64179375
Matching JNJ-64179375 placebo (normal saline) administered as IV infusion as a single dose on Day 1.
Drug: Apixaban 2.5 mg
Apixaban 2.5 mg administered orally twice a day for 10 to 14 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.
Up to Day 10 to 14 (visit observation period)
Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated 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 assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
Up to Day 10 to 14 (visit observation period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
Up to Day 10 to 14 (visit observation period)
Number of Participants With Major Bleeding Event (CEC-adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.
Up to Day 10 to 14 (visit observation period)
Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
Up to Day 10 to 14 (visit observation period)
Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)
Time Frame: Up to Day 10 and 14 (visit observation period)
Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
Up to Day 10 and 14 (visit observation period)
Number of Participants With Minimal Bleeding Events (CEC-adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria.
Up to Day 10 to 14 (visit observation period)
Number of Participants With Major VTE (CEC-adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
Up to Day 10 to 14 (visit observation period)
Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
Up to Day 10 to 14 (visit observation period)
Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with nonfatal PE (adjudicated by CEC) were reported.
Up to Day 10 to 14 (visit observation period)
Number of Participants With Death (CEC-adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with death (adjudicated by CEC) were reported.
Up to Day 10 to 14 (visit observation period)
Number of Participants With Proximal and Distal DVT (CEC-adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
Up to Day 10 to 14 (visit observation period)
Number of Participants With Distal DVT (CEC-adjudicated)
Time Frame: Up to Day 10 to 14 (visit observation period)
Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Up to Day 10 to 14 (visit observation period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108344
  • 2016-004550-15 (EudraCT Number)
  • 64179375THR2001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery

Clinical Trials on JNJ-64179375 0.3 mg/kg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings