AzTrials
AzTrials

VTE Prophylaxis With Anticoagulation After Total Knee Replacement SurgeryPhase 2TEXT-TKRNCT03251482

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

A Phase 2 study testing JNJ-64179375 0.3 mg/kg, JNJ-64179375 0.6 mg/kg and JNJ-64179375 1.2 mg/kg in people with VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery, run by Janssen Research & Development, LLC at 103 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
JNJ-64179375 0.3 mg/kg, JNJ-64179375 0.6 mg/kg and JNJ-64179375 1.2 mg/kg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
308 participants
Where
103 sitesin 16 countries
Study dates
13 Nov 2017to 5 Nov 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

103 sites in 16 countries.

103 sites in 16 countries

Japan10 sites

  • Matsudo City General Hospital

    Chiba, 270-2296

  • Hakodate Goryokaku Hospital

    Hakodate, 040-8611

  • Ritsuzankai Iida Hospital

    Iida-shi, 395-8505

  • Itami City Hospital

    Itami-shi, 664-8540

  • Yonemori Hospital

    Kagoshima, 890-0062

  • Bange Kousei General Hospital

    Kawanuma-Gun, 969-6593

  • Osaka Saiseikai Nakatsu Hospital

    Osaka, 530-0012

  • Osaka Rosai Hospital

    Osaka, 591-8025

  • Tokushima Municipal Hospital

    Tokushima, 770-0812

  • Yuaikai Tomishiro Central Hospital

    Tomishiro, 901-0243

Other trials in Japan

Poland10 sites

  • Klinika Ortopedii i Traumatologii UMB

    Bialystok, 15-276

  • Oddzial Ortopedii i Traumatologii - Szpital Ogolny im. W.Ginela

    Grajewo, 19-203

  • Klinika Ortopedii Gornoslaskie Centrum Medyczne

    Katowice, 40-635

  • Oddzial Ortopedii i Traumatologii Szpital Specjalistyczny im. L.Rydygiera

    Krakow, 31-826

  • SP ZOZ MSWiA w Krakowie Oddzial Urazowo-Ortopedyczny

    Krakow, 33-332

  • CSK UM Klinika Ortopedii

    Lodz, 92-213

  • Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny

    Lublin, 20-718

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

    Poznan, 61-545

  • Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika

    Tarnów, 33-100

  • Oddzial Chirurgii Urazowej iOrtopedycznej,Wojewodzki Szpital Brodnowski, SPZOZ

    Warsaw, 03-242

Other trials in Poland

Brazil9 sites

  • Universidade Federal de Minas Gerais (UFMG) - Faculdade de Medicina

    Belo Horizonte, 30130-100

  • Hospital Sao Francisco de Assis

    Belo Horizonte, 30360-290

  • Unicamp - Hospital de Clinicas

    Campinas, 13083-888

  • Uniort.e - Hospital de ortopedia

    Londrina, 86050-000

  • Irmandade da Santa Casa de Misericórdia de Marília

    Marília, 17515-000

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

  • Hospital e Maternidade Dr Christovão da Gama

    Santo André, 09030-010

  • Hospital Estadual Mario covas

    Santo André, 09190-615

  • Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

    São Paulo, 05403-010

Other trials in Brazil

Italy8 sites

  • Cliniche Humanitas Gavazzeni

    Bergamo, 24125

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • IRCCS Policlinico San Donato

    S. Donato Milanese, 20097

  • A.O.U. Città della Salute e della Scienza

    Torino, 10126

  • Ospedale Mauriziano (Torino)

    Torino, 10128

Other trials in Italy

Russia8 sites

  • Barnaul Federal Center of Traumatology, Orthopedics and Endoprothesis replacement

    Barnaul, 656045

  • Russian Ilizarov Scientific Center For Restorative Traumatology And Ortopaedics

    Kurgan, 640014

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

    Moscow, 117049

  • Privolzhsky Research Medical University of Ministry of Health of Russian Federation

    Nizhny Novgorod, 603155

  • St. Petersburg State Medical Institution City Multifunctional Hospital #2

    Saint Petersburg, 194354

  • Russian Research Institute of Traumatology and Orthopaedics n.a.R.R.Vreden

    Saint Petersburg, 195427

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

    Samara, 443095

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

    Yaroslavl, 150003

Other trials in Russia

Spain8 sites

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hosp. Univ. Fund. Jimenez Diaz

    Madrid, 28040

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

Other trials in Spain

Ukraine8 sites

  • Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009

  • Ivano-Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk, 76008

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

    Kharkiv, 61024

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

    Kharkiv, 61176

  • Kyiv Regional Clinical Hospital

    Kyiv, 04107

  • Communal Institution of Lviv Regional Council 'Lypa Lviv Regional Hospital'

    Lviv-Vynnyky, 79495

  • Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

    Vinnytsia, 21018

  • Zaporizhzhia Regional Clinical Hospital

    Zaporizhzhya, 69600

Other trials in Ukraine

United States7 sites

  • Florida Research Associates, LLC

    DeLand, Florida, 32720

  • Denver Metro Orthopedics, PC

    Englewood, Colorado, 80113

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas, 77024

  • Avanza research

    Pensacola, Florida, 32504

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • University Orthopedic and Joint Replacement Center

    Tamarac, Florida, 33321

  • Harbor-UCLA Medical Center

    Torrance, California, 90509

Other trials in United States

Argentina7 sites

  • Hospital Italiano de Buenos Aires

    Caba, C1199ABB

  • Clínica Adventista Belgrano

    CABA, C1430EGF

  • Hospital San Roque

    Córdoba, 5000

  • Clínica Chutro

    Córdoba, X5000EPU

  • Hospital Italiano La Plata

    La Plata, B1900AXI

  • Sanatorio Britanico de Rosario

    Rosario, 2000

  • Sanatorio San Miguel

    San Miguel, B1663GFL

Other trials in Argentina

Turkey (Türkiye)7 sites

  • Ankara Numune Research and Training Hospital

    Ankara, 06100

  • Dışkapı Yıldırım Beyazıd Training and Research Hospital

    Ankara, 06110

  • Yıldırım Beyazıt University Yenimahalle Training and Research Hospital

    Ankara, 06370

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

    Ankara, 06800

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147

  • Umraniye Training and Research Hospital

    Istanbul, 34764

  • Izmir Tepecik Training and Research Hospital

    Izmir, 35180

Other trials in Turkey (Türkiye)

Malaysia5 sites

  • University Malaya Medical Center

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Hospital Miri

    Miri, 98000

  • Hospital Sibu

    Sibu, 96000

  • Hospital Sultan Abdul Halim

    Sungai Petani, 08000

Other trials in Malaysia

Belgium4 sites

  • ZNA Middelheim

    Antwerp, 2020

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • Jessa Ziekenhuis

    Hasselt, 3500

  • ZNA Jan Palfijn

    Merksem, 2170

Other trials in Belgium

Latvia4 sites

  • Regional Hospital of Liepaja

    Liepāja, LV-3414

  • Riga 2nd Hospital

    Riga, LV1004

  • Hospital of Traumatology and Orthopedics

    Riga, LV1005

  • Vidzemes Hospital

    Valmiera, LV-4201

Other trials in Latvia

Bulgaria3 sites

  • Multiprofile Hospital for Active Treatment Russe

    Rousse, 7002

  • Acibadem City Clinic Tokuda Hospital

    Sofa, 1407

  • Military Medical Academy

    Sofia, 1606

Other trials in Bulgaria

Canada3 sites

  • Lakeridge Health Ajax

    Ajax, Ontario, L1S 2J4

  • Source Trial Solutions Inc.

    Kitchener, Ontario, N2M 1A1

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT50161

  • Klaipeda University Hospital

    Klaipėda, 92288

Other trials in Lithuania

About this study

Official title: 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).

Read the 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.

Being tested
JNJ-64179375 0.3 mg/kg, JNJ-64179375 0.6 mg/kg, JNJ-64179375 1.2 mg/kg, JNJ-64179375 (Dose to be Determined), JNJ-64179375 A mg/kg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-64179375 0.3 mg/kgDrug

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

  • JNJ-64179375 0.6 mg/kgDrug

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

  • JNJ-64179375 1.2 mg/kgDrug

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

  • JNJ-64179375 (Dose to be Determined)Drug

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

  • JNJ-64179375 A mg/kgDrug

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

  • JNJ-64179375 B mg/kgDrug

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

  • JNJ-64179375 C mg/kgDrug

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

  • JNJ-64179375 D mg/kgDrug

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

  • Placebo JNJ-64179375Drug

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

  • Apixaban placeboDrug

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

  • Apixaban 2.5 mgDrug

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

Study groups in NCT03251482
Study groupRoleWhat they receive
Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375 0.3 mg/kg; Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg
Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375 0.6 mg/kg; Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg
Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375 1.2 mg/kg; Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg
Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375 (Dose to be Determined); Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg
Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375 (Dose to be Determined); Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg
Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375 (Dose to be Determined); Drug: Placebo JNJ-64179375; Drug: Apixaban placebo; Drug: Apixaban 2.5 mg
Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placeboExperimentalParticipants 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.
Receives: Drug: JNJ-64179375 A mg/kg; Drug: Apixaban placebo
Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placeboExperimentalParticipants 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.
Receives: Drug: JNJ-64179375 B mg/kg; Drug: Apixaban placebo
Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placeboExperimentalParticipants 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.
Receives: Drug: JNJ-64179375 C mg/kg; Drug: Apixaban placebo
Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placeboExperimentalParticipants 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.
Receives: Drug: JNJ-64179375 D mg/kg; Drug: Apixaban placebo
Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mgExperimentalParticipants 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.
Receives: Drug: Placebo JNJ-64179375; Drug: Apixaban 2.5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)

    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.

    Measured: Up to Day 10 to 14 (visit observation period)

  2. Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)

    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.

    Measured: Up to Day 10 to 14 (visit observation period)

Secondary outcomes (11)

  1. Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)

    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.

    Measured: Up to Day 10 to 14 (visit observation period)

  2. Number of Participants With Major Bleeding Event (CEC-adjudicated)

    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.

    Measured: Up to Day 10 to 14 (visit observation period)

  3. Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)

    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.

    Measured: Up to Day 10 to 14 (visit observation period)

  4. Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)

    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.

    Measured: Up to Day 10 and 14 (visit observation period)

  5. Number of Participants With Minimal Bleeding Events (CEC-adjudicated)

    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.

    Measured: Up to Day 10 to 14 (visit observation period)

  6. Number of Participants With Major VTE (CEC-adjudicated)

    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.

    Measured: Up to Day 10 to 14 (visit observation period)

  7. Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)

    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.

    Measured: Up to Day 10 to 14 (visit observation period)

  8. Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)

    Number of participants with nonfatal PE (adjudicated by CEC) were reported.

    Measured: Up to Day 10 to 14 (visit observation period)

  9. Number of Participants With Death (CEC-adjudicated)

    Number of participants with death (adjudicated by CEC) were reported.

    Measured: Up to Day 10 to 14 (visit observation period)

  10. Number of Participants With Proximal and Distal DVT (CEC-adjudicated)

    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.

    Measured: Up to Day 10 to 14 (visit observation period)

  11. Number of Participants With Distal DVT (CEC-adjudicated)

    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.

    Measured: Up to Day 10 to 14 (visit observation period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2017
  2. Study start13 Nov 2017
  3. Primary completion5 Nov 2018
  4. Study completion5 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double Blinded
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03251482
Sponsor's protocol ID
CR108344
Other IDs
2016-004550-15, 64179375THR2001, 2016
Acronym
TEXT-TKR
Status last verified
Nov 2019
First submitted
14 Aug 2017
Last updated
25 Nov 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-64179375 0.3 mg/kg, JNJ-64179375 0.6 mg/kg and JNJ-64179375 1.2 mg/kg in people with VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery, run by Janssen Research & Development, LLC at 103 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in Japan, Poland, Brazil, Italy, Russia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated) (time frame: Up to Day 10 to 14 (visit observation period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03251482.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in