A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
Completed · Phase 2 · Has a placebo group
Conditions studied: VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery
In brief
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).
Key facts
- Study ID
- NCT03251482
- Run by
- Janssen Research & Development, LLC
- People needed
- 308
- Starts
- 2017-11-13
- Expected to finish
- 2018-11-05
- Last updated by the study team
- 2019-11-25
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Harbor-UCLA Medical Center — Torrance, California, United States
- Denver Metro Orthopedics, PC — Englewood, Colorado, United States
- Florida Research Associates, LLC — DeLand, Florida, United States
- Avanza research — Pensacola, Florida, United States
- University Orthopedic and Joint Replacement Center — Tamarac, Florida, United States
- Memorial Hermann Memorial City Medical Center — Houston, Texas, United States
- Hospital Italiano de Buenos Aires — Caba, Argentina
- Clínica Adventista Belgrano — CABA, Argentina
- Hospital San Roque — Córdoba, Argentina
- Clínica Chutro — Córdoba, Argentina
- Hospital Italiano La Plata — La Plata, Argentina
- Sanatorio Britanico de Rosario — Rosario, Argentina
- Sanatorio San Miguel — San Miguel, Argentina
- ZNA Middelheim — Antwerp, Belgium
- Ziekenhuis Oost-Limburg — Genk, Belgium
- Jessa Ziekenhuis — Hasselt, Belgium
- ZNA Jan Palfijn — Merksem, Belgium
- Universidade Federal de Minas Gerais (UFMG) - Faculdade de Medicina — Belo Horizonte, Brazil
- Hospital Sao Francisco de Assis — Belo Horizonte, Brazil
- Unicamp - Hospital de Clinicas — Campinas, Brazil
- Uniort.e - Hospital de ortopedia — Londrina, Brazil
- Irmandade da Santa Casa de Misericórdia de Marília — Marília, Brazil
- Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Brazil
- Hospital e Maternidade Dr Christovão da Gama — Santo André, Brazil
- Arizona Research Center — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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