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

NCT ID: NCT03251482

Last Updated: 2019-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-13

Study Completion Date

2018-11-05

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Blinded
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

JNJ-64179375 0.3 mg/kg

Intervention Type DRUG

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

Placebo JNJ-64179375

Intervention Type DRUG

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

Apixaban placebo

Intervention Type DRUG

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

Apixaban 2.5 mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

JNJ-64179375 0.6 mg/kg

Intervention Type DRUG

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

Placebo JNJ-64179375

Intervention Type DRUG

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

Apixaban placebo

Intervention Type DRUG

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

Apixaban 2.5 mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

JNJ-64179375 1.2 mg/kg

Intervention Type DRUG

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

Placebo JNJ-64179375

Intervention Type DRUG

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

Apixaban placebo

Intervention Type DRUG

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

Apixaban 2.5 mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

JNJ-64179375 (Dose to be Determined)

Intervention Type DRUG

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

Placebo JNJ-64179375

Intervention Type DRUG

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

Apixaban placebo

Intervention Type DRUG

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

Apixaban 2.5 mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

JNJ-64179375 (Dose to be Determined)

Intervention Type DRUG

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

Placebo JNJ-64179375

Intervention Type DRUG

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

Apixaban placebo

Intervention Type DRUG

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

Apixaban 2.5 mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

JNJ-64179375 (Dose to be Determined)

Intervention Type DRUG

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

Placebo JNJ-64179375

Intervention Type DRUG

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

Apixaban placebo

Intervention Type DRUG

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

Apixaban 2.5 mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

JNJ-64179375 A mg/kg

Intervention Type DRUG

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

Apixaban placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

JNJ-64179375 B mg/kg

Intervention Type DRUG

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

Apixaban placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

JNJ-64179375 C mg/kg

Intervention Type DRUG

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

Apixaban placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

JNJ-64179375 D mg/kg

Intervention Type DRUG

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

Apixaban placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Placebo JNJ-64179375

Intervention Type DRUG

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

Apixaban 2.5 mg

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

JNJ-64179375 0.6 mg/kg

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

Intervention Type DRUG

JNJ-64179375 1.2 mg/kg

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

Intervention Type DRUG

JNJ-64179375 (Dose to be Determined)

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

Intervention Type DRUG

JNJ-64179375 A mg/kg

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

Intervention Type DRUG

JNJ-64179375 B mg/kg

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

Intervention Type DRUG

JNJ-64179375 C mg/kg

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

Intervention Type DRUG

JNJ-64179375 D mg/kg

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

Intervention Type DRUG

Placebo JNJ-64179375

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

Intervention Type DRUG

Apixaban placebo

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

Intervention Type DRUG

Apixaban 2.5 mg

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Arizona Research Center

Phoenix, Arizona, United States

Site Status

Harbor-UCLA Medical Center

Torrance, California, United States

Site Status

Denver Metro Orthopedics, PC

Englewood, Colorado, United States

Site Status

Florida Research Associates, LLC

DeLand, Florida, United States

Site Status

Avanza research

Pensacola, Florida, United States

Site Status

University Orthopedic and Joint Replacement Center

Tamarac, Florida, United States

Site Status

Memorial Hermann Memorial City Medical Center

Houston, Texas, United States

Site Status

Hospital Italiano de Buenos Aires

Caba, , Argentina

Site Status

Clínica Adventista Belgrano

CABA, , Argentina

Site Status

Hospital San Roque

Córdoba, , Argentina

Site Status

Clínica Chutro

Córdoba, , Argentina

Site Status

Hospital Italiano La Plata

La Plata, , Argentina

Site Status

Sanatorio Britanico de Rosario

Rosario, , Argentina

Site Status

Sanatorio San Miguel

San Miguel, , Argentina

Site Status

ZNA Middelheim

Antwerp, , Belgium

Site Status

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status

Jessa Ziekenhuis

Hasselt, , Belgium

Site Status

ZNA Jan Palfijn

Merksem, , Belgium

Site Status

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

Belo Horizonte, , Brazil

Site Status

Hospital Sao Francisco de Assis

Belo Horizonte, , Brazil

Site Status

Unicamp - Hospital de Clinicas

Campinas, , Brazil

Site Status

Uniort.e - Hospital de ortopedia

Londrina, , Brazil

Site Status

Irmandade da Santa Casa de Misericórdia de Marília

Marília, , Brazil

Site Status

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Site Status

Hospital e Maternidade Dr Christovão da Gama

Santo André, , Brazil

Site Status

Hospital Estadual Mario covas

Santo André, , Brazil

Site Status

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

São Paulo, , Brazil

Site Status

Multiprofile Hospital for Active Treatment Russe

Rousse, , Bulgaria

Site Status

Acibadem City Clinic Tokuda Hospital

Sofa, , Bulgaria

Site Status

Military Medical Academy

Sofia, , Bulgaria

Site Status

Lakeridge Health Ajax

Ajax, Ontario, Canada

Site Status

Source Trial Solutions Inc.

Kitchener, Ontario, Canada

Site Status

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status

Cliniche Humanitas Gavazzeni

Bergamo, , Italy

Site Status

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, , Italy

Site Status

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Site Status

Istituto Clinico Humanitas

Rozzano, , Italy

Site Status

IRCCS Policlinico San Donato

S. Donato Milanese, , Italy

Site Status

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

Torino, , Italy

Site Status

Ospedale Mauriziano (Torino)

Torino, , Italy

Site Status

Matsudo City General Hospital

Chiba, , Japan

Site Status

Hakodate Goryokaku Hospital

Hakodate, , Japan

Site Status

Ritsuzankai Iida Hospital

Iida-shi, , Japan

Site Status

Itami City Hospital

Itami-shi, , Japan

Site Status

Yonemori Hospital

Kagoshima, , Japan

Site Status

Bange Kousei General Hospital

Kawanuma-Gun, , Japan

Site Status

Osaka Saiseikai Nakatsu Hospital

Osaka, , Japan

Site Status

Osaka Rosai Hospital

Osaka, , Japan

Site Status

Tokushima Municipal Hospital

Tokushima, , Japan

Site Status

Yuaikai Tomishiro Central Hospital

Tomishiro, , Japan

Site Status

Regional Hospital of Liepaja

Liepāja, , Latvia

Site Status

Riga 2nd Hospital

Riga, , Latvia

Site Status

Hospital of Traumatology and Orthopedics

Riga, , Latvia

Site Status

Vidzemes Hospital

Valmiera, , Latvia

Site Status

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Site Status

Klaipeda University Hospital

Klaipėda, , Lithuania

Site Status

University Malaya Medical Center

Kuala Lumpur, , Malaysia

Site Status

Hospital Tengku Ampuan Afzan

Kuantan, , Malaysia

Site Status

Hospital Miri

Miri, , Malaysia

Site Status

Hospital Sibu

Sibu, , Malaysia

Site Status

Hospital Sultan Abdul Halim

Sungai Petani, , Malaysia

Site Status

Klinika Ortopedii i Traumatologii UMB

Bialystok, , Poland

Site Status

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

Grajewo, , Poland

Site Status

Klinika Ortopedii Gornoslaskie Centrum Medyczne

Katowice, , Poland

Site Status

Oddzial Ortopedii i Traumatologii Szpital Specjalistyczny im. L.Rydygiera

Krakow, , Poland

Site Status

SP ZOZ MSWiA w Krakowie Oddzial Urazowo-Ortopedyczny

Krakow, , Poland

Site Status

CSK UM Klinika Ortopedii

Lodz, , Poland

Site Status

Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny

Lublin, , Poland

Site Status

Klinika Ortopedii I Traumatologii,Szpital Kliniczny Ortopedyczno-Rehabilitacyjny UM

Poznan, , Poland

Site Status

Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika

Tarnów, , Poland

Site Status

Oddzial Chirurgii Urazowej iOrtopedycznej,Wojewodzki Szpital Brodnowski, SPZOZ

Warsaw, , Poland

Site Status

Barnaul Federal Center of Traumatology, Orthopedics and Endoprothesis replacement

Barnaul, , Russia

Site Status

Russian Ilizarov Scientific Center For Restorative Traumatology And Ortopaedics

Kurgan, , Russia

Site Status

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

Moscow, , Russia

Site Status

Privolzhsky Research Medical University of Ministry of Health of Russian Federation

Nizhny Novgorod, , Russia

Site Status

St. Petersburg State Medical Institution City Multifunctional Hospital #2

Saint Petersburg, , Russia

Site Status

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

Saint Petersburg, , Russia

Site Status

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

Samara, , Russia

Site Status

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

Yaroslavl, , Russia

Site Status

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Site Status

Hosp. Clinico San Carlos

Madrid, , Spain

Site Status

Hosp. Univ. Fund. Jimenez Diaz

Madrid, , Spain

Site Status

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Site Status

Hosp. Univ. La Paz

Madrid, , Spain

Site Status

Corporacio Sanitari Parc Tauli

Sabadell, , Spain

Site Status

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Site Status

Hosp. Univ. I Politecni La Fe

Valencia, , Spain

Site Status

Ankara Numune Research and Training Hospital

Ankara, , Turkey (Türkiye)

Site Status

Dışkapı Yıldırım Beyazıd Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Yıldırım Beyazıt University Yenimahalle Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital

Ankara, , Turkey (Türkiye)

Site Status

Bakirkoy Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Umraniye Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Izmir Tepecik Training and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status

Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, , Ukraine

Site Status

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, , Ukraine

Site Status

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

Kharkiv, , Ukraine

Site Status

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

Kharkiv, , Ukraine

Site Status

Kyiv Regional Clinical Hospital

Kyiv, , Ukraine

Site Status

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

Lviv-Vynnyky, , Ukraine

Site Status

Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

Vinnytsia, , Ukraine

Site Status

Zaporizhzhia Regional Clinical Hospital

Zaporizhzhia, , Ukraine

Site Status

Countries

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United States Argentina Belgium Brazil Bulgaria Canada Italy Japan Latvia Lithuania Malaysia Poland Russia Spain Turkey (Türkiye) Ukraine

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-004550-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64179375THR2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108344

Identifier Type: -

Identifier Source: org_study_id

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Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin
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Dimolegin® (60 mg) Given Once Daily in Patients Undergoing Total Hip or Knee Replacement Compared to Enoxaparin
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Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee Replacement
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Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
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Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
NCT06474182 RECRUITING NA
Venous Thromboembolic Prophylaxis After Trauma: Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin
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Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery
NCT01344954 COMPLETED PHASE2
BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
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Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery
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Prevention of Thromboembolic Events in Total Knee Replacement Patients
NCT03393481 WITHDRAWN PHASE2