drugset / Trial / NCT03251482
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
RandomizedParallel-groupDouble-blindPrevention
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. 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).
Timeline
- Start
- 2017-11-13
- Primary completion
- 2018-11-05
- Completion
- 2018-11-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 2.5 mg | Oral |
| Subject | ICHORCUMAB | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | ICHORCUMAB | Monoclonal antibody | 0.6 mg/kg | Intravenous |
| Subject | ICHORCUMAB | Monoclonal antibody | 1.2 mg/kg | Intravenous |
Indications
No indication recorded.