Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2018
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT03251482
Start Date
November 13 2017
End Date
November 5 2018
Last Update
November 25 2019
Active Locations (103)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
Harbor-UCLA Medical Center
Torrance, California, United States, 90509
3
Denver Metro Orthopedics, PC
Englewood, Colorado, United States, 80113
4
Florida Research Associates, LLC
DeLand, Florida, United States, 32720