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

NCT03251482

Phase 2 Completed 308 enrolled Janssen Research & Development, LLC
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

EvaluationDrugModalityDoseRoute
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.