Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03251482 | A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery | PHASE2 | COMPLETED | 308 | — | — | Nov 13, 2017 | Nov 5, 2018 | Nov 25, 2019 | 103 | United States, Argentina +14 |
Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.
Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated 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 assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
| Arm | Type | Description |
|---|---|---|
| Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban) | EXPERIMENTAL | Participants will receive JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenously (IV) or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
| Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban) | EXPERIMENTAL | Participants will receive JNJ-64179375 0.6 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
| Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban) | EXPERIMENTAL | Participants will receive JNJ-64179375 1.2 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
| Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban) | EXPERIMENTAL | Participants will receive JNJ-64179375 Dose to be determined (TBD) based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
| Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban) | EXPERIMENTAL | Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
| Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban) | EXPERIMENTAL | Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
| Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo | EXPERIMENTAL | Participants will receive JNJ-64179375 Dose A mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days. |
| Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo | EXPERIMENTAL | Participants will receive JNJ-64179375 Dose B mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days. |
| Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo | EXPERIMENTAL | Participants will receive JNJ-64179375 Dose C mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days. |
| Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo | EXPERIMENTAL | Participants will receive JNJ-64179375 Dose D mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days. |
| Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg | EXPERIMENTAL | Participants will receive JNJ-64179375 placebo (saline) IV as a single dose on Day 1 and apixaban 2.5 mg orally twice a day for 10 to 14 days. |
| Name | Type | Description |
|---|---|---|
| JNJ-64179375 0.3 mg/kg | DRUG | JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion as a single dose on Day 1. |
| JNJ-64179375 0.6 mg/kg | DRUG | JNJ-64179375 0.6 mg/kg IV infusion as a single dose on Day 1. |
| JNJ-64179375 1.2 mg/kg | DRUG | JNJ-64179375 1.2 mg/kg IV infusion as a single dose on Day 1. |
| JNJ-64179375 (Dose to be Determined) | DRUG | JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1. |
| JNJ-64179375 A mg/kg | DRUG | JNJ-64179375 Dose A mg/kg IV as a single dose on Day 1. |
| JNJ-64179375 B mg/kg | DRUG | JNJ-64179375 Dose B mg/kg IV as a single dose on Day 1. |
| JNJ-64179375 C mg/kg | DRUG | JNJ-64179375 Dose C mg/kg IV as a single dose on Day 1. |
| JNJ-64179375 D mg/kg | DRUG | JNJ-64179375 Dose D mg/kg IV as a single dose on Day 1. |
| Placebo JNJ-64179375 | DRUG | Matching JNJ-64179375 placebo (normal saline) administered as IV infusion as a single dose on Day 1. |
| Apixaban placebo | DRUG | Matching apixaban placebo administered orally twice a day for 10 to 14 days. |
| Apixaban 2.5 mg | DRUG | Apixaban 2.5 mg administered orally twice a day for 10 to 14 days. |
Inclusion Criteria: * 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) * Befo...