A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
- Conditions
- VTE prophylaxis with anticoagulation after Total Knee Replacement surgery
- Registration Number
- JPRN-jRCT2080223833
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 150
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
- 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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of Participants With any Bleeding Event (Part 1)<br>Baseline up to Day 10-14 Visit<br>Number of Participants With any Bleeding Event (Part 2)<br>Baseline up to Day 10-14 Visit<br>Number of Participants With Total Venous Thromboembolism (VTE) (Part 1)<br>Baseline up to Day 10-14 Visit<br>Number of Participants With Total Venous Thromboembolism (VTE) (Part 2)<br>Baseline up to Day 10-14 Visit
- Secondary Outcome Measures
Name Time Method