The purpose of this study is to determine the efficacy of JNJ-70033093 in preventing total venous thromboembolism (VTE) events (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death) during the treatment period.
JNJ-70033093 is an oral anticoagulant for prevention and treatment of thromboembolic events (for example, VTE) that binds and inhibits activated form of human coagulation Factor XI (FXIa) with high affinity and selectivity. The study will consist of 3 phases: up to 30-day screening phase before total knee replacement (TKR) surgery, 10 to14 day postoperative dosing phase, and 4-week follow-up phase. The hypothesis of this study is JNJ-70033093 reduces risk of total VTE during treatment period. The total duration of participation following randomization will be approximately 6 weeks. Efficacy evaluations include unilateral venography assessment of operated leg and assessments of symptomatic DVT, PE, or death. Safety evaluation includes adverse events, clinical laboratory tests, and physical examinations. The safety and efficacy will be monitored throughout the study.
| Condition | Repair of knee joint, Knee Surgery, Knee Replacement |
|---|---|
| Treatment | Placebo, JNJ-70033093 25 mg, JNJ-70033093 50 mg, JNJ-70033093 100 mg, JNJ-70033093 200 mg, JNJ-70033093, dose to be determined, Enoxaparin 40 mg |
| Clinical Study Identifier | NCT03891524 |
| Sponsor | Janssen Research & Development, LLC |
| Last Modified on | 11 April 2021 |
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